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Medical Aid in Dying Should Be Legal, Says Ethicist
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine.
Right now, there are 10 states and the District of Columbia that have had some version of medical assistance in dying approved and on the books. That basically means that about 20% of Americans have access where they live to a physician who can prescribe a lethal dose of medication to them if they’re terminally ill and can ingest the medication themselves. That leaves many Americans not covered by this kind of access to this kind of service.
Many of you watching this may live in states where it is legal, like Oregon, Washington, New Jersey, Colorado, and Hawaii. I know many doctors say, “I’m not going to do that.” It’s not something that anyone is compelling a doctor to do. For some Americans, access is not just about where they live but whether there is a doctor willing to participate with them in bringing about their accelerated death, knowing that they’re inevitably going to die.
There’s not much we can do about that. It’s up to the conscience of each physician as to what they’re comfortable with. Certainly, there are other things that can be done to extend the possibility of having this available.
One thing that’s taking place is that, after lawsuits were filed, Vermont and Oregon have given up on their residency requirement, so you don’t have to be there 6 months or a year in order to use this opportunity. It’s legal now to move to the state or visit the state, and as soon as you get there, sign up for this kind of end-of-life intervention.
New Jersey is also being sued. I’ll predict that every state that has a residency requirement, when sued in court, is going to lose because we’ve long recognized the right of Americans to seek out healthcare in the United States, wherever they want to go.
If some states have made this a legitimate medical procedure, courts are going to say you can’t restrict it only to state residents. If someone wants to use a service, they’re entitled to show up from another state or another place and use it. I’m not sure about foreign nationals, but I’m very sure that Americans can go state to state in search of legitimate medical procedures.
The other bills that are out there, however, are basically saying they want to emulate Oregon, Washington, and the other states and say that the terminally ill, with severe restrictions, are going to be able to get this service without going anywhere.
The restrictions include a diagnosis of terminal illness and that you have to be deemed mentally competent. You can’t use this if you have Alzheimer’s or severe depression. You have to make a request twice with a week or two in between to make sure that your request is authentic. And obviously, everyone is on board to make sure that you’re not being coerced or pushed somehow into requesting a somewhat earlier death than you would have experienced without having the availability of the pills.
You also have to take the pills yourself or be able to pull a switch so that you could use a feeding tube–type administration. If you can’t do that, say due to ALS, you’re not eligible to use medical aid in dying. It’s a pretty restricted intervention.
Many people who get pills after going through these restrictions in the states that permit it don’t use it. As many as one third say they like having it there as a safety valve or a parachute, but once they know they could end their life sooner, then they’re going to stick it out.
Should states make this legal? New York, Massachusetts, Florida, and many other states have bills that are moving through. I’m going to say yes. We’ve had Oregon and Washington since the late 1990s with medical aid in dying on the books. There doesn’t seem to be any evidence of pushing people to use this, of bias against the disabled, or bigotry against particular ethnic or racial groups being used to encourage people to end their life sooner.
I think it is an option that Americans want. I think it’s an option that makes some sense. I’m well aware that we also have to make sure that people know about hospice. In some of these states, medical aid in dying is offered as a part of hospice — not all, but a few. Not everybody wants hospice once they realize that they’re dying and that it is coming relatively soon. They may want to leave with family present, with a ceremony, or with a quality of life that they desire.
Past experience says let’s continue to expand availability in each state. Let’s also realize that we have to keep the restrictions in place on how it’s used because they have protected us against abuse. Let’s understand that every doctor has an option to do this or not do this. It’s a matter of conscience and a matter of comfort.
I think legalization is the direction we’re going to be going in. Getting rid of the residency requirements that have been around, as I think courts are going to overturn them, also gives a push to the idea that once the service is in this many states, it’s something that should be available if there are doctors willing to do it.
I’m Art Caplan at the Division of Medical Ethics at NYU Grossman School of Medicine. New York, NY. Thank you for watching.
Arthur L. Caplan, PhD, has disclosed the following relevant financial relationships:
- Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position)
- Serves as a contributing author and adviser for: Medscape
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine.
Right now, there are 10 states and the District of Columbia that have had some version of medical assistance in dying approved and on the books. That basically means that about 20% of Americans have access where they live to a physician who can prescribe a lethal dose of medication to them if they’re terminally ill and can ingest the medication themselves. That leaves many Americans not covered by this kind of access to this kind of service.
Many of you watching this may live in states where it is legal, like Oregon, Washington, New Jersey, Colorado, and Hawaii. I know many doctors say, “I’m not going to do that.” It’s not something that anyone is compelling a doctor to do. For some Americans, access is not just about where they live but whether there is a doctor willing to participate with them in bringing about their accelerated death, knowing that they’re inevitably going to die.
There’s not much we can do about that. It’s up to the conscience of each physician as to what they’re comfortable with. Certainly, there are other things that can be done to extend the possibility of having this available.
One thing that’s taking place is that, after lawsuits were filed, Vermont and Oregon have given up on their residency requirement, so you don’t have to be there 6 months or a year in order to use this opportunity. It’s legal now to move to the state or visit the state, and as soon as you get there, sign up for this kind of end-of-life intervention.
New Jersey is also being sued. I’ll predict that every state that has a residency requirement, when sued in court, is going to lose because we’ve long recognized the right of Americans to seek out healthcare in the United States, wherever they want to go.
If some states have made this a legitimate medical procedure, courts are going to say you can’t restrict it only to state residents. If someone wants to use a service, they’re entitled to show up from another state or another place and use it. I’m not sure about foreign nationals, but I’m very sure that Americans can go state to state in search of legitimate medical procedures.
The other bills that are out there, however, are basically saying they want to emulate Oregon, Washington, and the other states and say that the terminally ill, with severe restrictions, are going to be able to get this service without going anywhere.
The restrictions include a diagnosis of terminal illness and that you have to be deemed mentally competent. You can’t use this if you have Alzheimer’s or severe depression. You have to make a request twice with a week or two in between to make sure that your request is authentic. And obviously, everyone is on board to make sure that you’re not being coerced or pushed somehow into requesting a somewhat earlier death than you would have experienced without having the availability of the pills.
You also have to take the pills yourself or be able to pull a switch so that you could use a feeding tube–type administration. If you can’t do that, say due to ALS, you’re not eligible to use medical aid in dying. It’s a pretty restricted intervention.
Many people who get pills after going through these restrictions in the states that permit it don’t use it. As many as one third say they like having it there as a safety valve or a parachute, but once they know they could end their life sooner, then they’re going to stick it out.
Should states make this legal? New York, Massachusetts, Florida, and many other states have bills that are moving through. I’m going to say yes. We’ve had Oregon and Washington since the late 1990s with medical aid in dying on the books. There doesn’t seem to be any evidence of pushing people to use this, of bias against the disabled, or bigotry against particular ethnic or racial groups being used to encourage people to end their life sooner.
I think it is an option that Americans want. I think it’s an option that makes some sense. I’m well aware that we also have to make sure that people know about hospice. In some of these states, medical aid in dying is offered as a part of hospice — not all, but a few. Not everybody wants hospice once they realize that they’re dying and that it is coming relatively soon. They may want to leave with family present, with a ceremony, or with a quality of life that they desire.
Past experience says let’s continue to expand availability in each state. Let’s also realize that we have to keep the restrictions in place on how it’s used because they have protected us against abuse. Let’s understand that every doctor has an option to do this or not do this. It’s a matter of conscience and a matter of comfort.
I think legalization is the direction we’re going to be going in. Getting rid of the residency requirements that have been around, as I think courts are going to overturn them, also gives a push to the idea that once the service is in this many states, it’s something that should be available if there are doctors willing to do it.
I’m Art Caplan at the Division of Medical Ethics at NYU Grossman School of Medicine. New York, NY. Thank you for watching.
Arthur L. Caplan, PhD, has disclosed the following relevant financial relationships:
- Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position)
- Serves as a contributing author and adviser for: Medscape
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine.
Right now, there are 10 states and the District of Columbia that have had some version of medical assistance in dying approved and on the books. That basically means that about 20% of Americans have access where they live to a physician who can prescribe a lethal dose of medication to them if they’re terminally ill and can ingest the medication themselves. That leaves many Americans not covered by this kind of access to this kind of service.
Many of you watching this may live in states where it is legal, like Oregon, Washington, New Jersey, Colorado, and Hawaii. I know many doctors say, “I’m not going to do that.” It’s not something that anyone is compelling a doctor to do. For some Americans, access is not just about where they live but whether there is a doctor willing to participate with them in bringing about their accelerated death, knowing that they’re inevitably going to die.
There’s not much we can do about that. It’s up to the conscience of each physician as to what they’re comfortable with. Certainly, there are other things that can be done to extend the possibility of having this available.
One thing that’s taking place is that, after lawsuits were filed, Vermont and Oregon have given up on their residency requirement, so you don’t have to be there 6 months or a year in order to use this opportunity. It’s legal now to move to the state or visit the state, and as soon as you get there, sign up for this kind of end-of-life intervention.
New Jersey is also being sued. I’ll predict that every state that has a residency requirement, when sued in court, is going to lose because we’ve long recognized the right of Americans to seek out healthcare in the United States, wherever they want to go.
If some states have made this a legitimate medical procedure, courts are going to say you can’t restrict it only to state residents. If someone wants to use a service, they’re entitled to show up from another state or another place and use it. I’m not sure about foreign nationals, but I’m very sure that Americans can go state to state in search of legitimate medical procedures.
The other bills that are out there, however, are basically saying they want to emulate Oregon, Washington, and the other states and say that the terminally ill, with severe restrictions, are going to be able to get this service without going anywhere.
The restrictions include a diagnosis of terminal illness and that you have to be deemed mentally competent. You can’t use this if you have Alzheimer’s or severe depression. You have to make a request twice with a week or two in between to make sure that your request is authentic. And obviously, everyone is on board to make sure that you’re not being coerced or pushed somehow into requesting a somewhat earlier death than you would have experienced without having the availability of the pills.
You also have to take the pills yourself or be able to pull a switch so that you could use a feeding tube–type administration. If you can’t do that, say due to ALS, you’re not eligible to use medical aid in dying. It’s a pretty restricted intervention.
Many people who get pills after going through these restrictions in the states that permit it don’t use it. As many as one third say they like having it there as a safety valve or a parachute, but once they know they could end their life sooner, then they’re going to stick it out.
Should states make this legal? New York, Massachusetts, Florida, and many other states have bills that are moving through. I’m going to say yes. We’ve had Oregon and Washington since the late 1990s with medical aid in dying on the books. There doesn’t seem to be any evidence of pushing people to use this, of bias against the disabled, or bigotry against particular ethnic or racial groups being used to encourage people to end their life sooner.
I think it is an option that Americans want. I think it’s an option that makes some sense. I’m well aware that we also have to make sure that people know about hospice. In some of these states, medical aid in dying is offered as a part of hospice — not all, but a few. Not everybody wants hospice once they realize that they’re dying and that it is coming relatively soon. They may want to leave with family present, with a ceremony, or with a quality of life that they desire.
Past experience says let’s continue to expand availability in each state. Let’s also realize that we have to keep the restrictions in place on how it’s used because they have protected us against abuse. Let’s understand that every doctor has an option to do this or not do this. It’s a matter of conscience and a matter of comfort.
I think legalization is the direction we’re going to be going in. Getting rid of the residency requirements that have been around, as I think courts are going to overturn them, also gives a push to the idea that once the service is in this many states, it’s something that should be available if there are doctors willing to do it.
I’m Art Caplan at the Division of Medical Ethics at NYU Grossman School of Medicine. New York, NY. Thank you for watching.
Arthur L. Caplan, PhD, has disclosed the following relevant financial relationships:
- Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position)
- Serves as a contributing author and adviser for: Medscape
A version of this article appeared on Medscape.com.
Five Bold Predictions for Long COVID in 2024
With a number of large-scale clinical trials underway and researchers on the hunt for new therapies, long COVID scientists are hopeful that this is the year patients — and doctors who care for them — will finally see improvements in treating their symptoms.
Here are five bold predictions — all based on encouraging research — that could happen in 2024. At the very least, they are promising signs of progress against a debilitating and frustrating disease.
#1: We’ll gain a better understanding of each long COVID phenotype
This past year, a wide breadth of research began showing that long COVID can be defined by a number of different disease phenotypes that present a range of symptoms.
Researchers identified four clinical phenotypes: Chronic fatigue-like syndrome, headache, and memory loss; respiratory syndrome, which includes cough and difficulty breathing; chronic pain; and neurosensorial syndrome, which causes an altered sense of taste and smell.
Identifying specific diagnostic criteria for each phenotype would lead to better health outcomes for patients instead of treating them as if it were a “one-size-fits-all disease,” said Nisha Viswanathan, MD, director of the long COVID program at UCLA Health, Los Angeles, California.
Ultimately, she hopes that this year her patients will receive treatments based on the type of long COVID they’re personally experiencing, and the symptoms they have, leading to improved health outcomes and more rapid relief.
“Many new medications are focused on different pathways of long COVID, and the challenge becomes which drug is the right drug for each treatment,” said Dr. Viswanathan.
#2: Monoclonal antibodies may change the game
We’re starting to have a better understanding that what’s been called “viral persistence” as a main cause of long COVID may potentially be treated with monoclonal antibodies. These are antibodies produced by cloning unique white blood cells to target the circulating spike proteins in the blood that hang out in viral reservoirs and cause the immune system to react as if it’s still fighting acute COVID-19.
Smaller-scale studies have already shown promising results. A January 2024 study published in The American Journal of Emergency Medicine followed three patients who completely recovered from long COVID after taking monoclonal antibodies. “Remission occurred despite dissimilar past histories, sex, age, and illness duration,” wrote the study authors.
Larger clinical trials are underway at the University of California, San Francisco, California, to test targeted monoclonal antibodies. If the results of the larger study show that monoclonal antibodies are beneficial, then it could be a game changer for a large swath of patients around the world, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.
“The idea is that the downstream damage caused by viral persistence will resolve itself once you wipe out the virus,” said Dr. Putrino.
#3: Paxlovid could prove effective for long COVID
The US Food and Drug Administration granted approval for Paxlovid last May for the treatment of mild to moderate COVID-19 in adults at a high risk for severe disease. The medication is made up of two drugs packaged together. The first, nirmatrelvir, works by blocking a key enzyme required for virus replication. The second, ritonavir, is an antiviral that’s been used in patients with HIV and helps boost levels of antivirals in the body.
In a large-scale trial headed up by Dr. Putrino and his team, the oral antiviral is being studied for use in the post-viral stage in patients who test negative for acute COVID-19 but have persisting symptoms of long COVID.
Similar to monoclonal antibodies, the idea is to quell viral persistence. If patients have long COVID because they can’t clear SAR-CoV-2 from their bodies, Paxlovid could help. But unlike monoclonal antibodies that quash the virus, Paxlovid stops the virus from replicating. It’s a different mechanism with the same end goal.
It’s been a controversial treatment because it’s life-changing for some patients and ineffective for others. In addition, it can cause a range of side effects such as diarrhea, nausea, vomiting, and an impaired sense of taste. The goal of the trial is to see which patients with long COVID are most likely to benefit from the treatment.
#4: Anti-inflammatories like metformin could prove useful
Many of the inflammatory markers persistent in patients with long COVID were similarly present in patients with autoimmune diseases like rheumatoid arthritis, according to a July 2023 study published in JAMA.
The hope is that anti-inflammatory medications may be used to reduce inflammation causing long COVID symptoms. But drugs used to treat rheumatoid arthritis like abatacept and infliximabcan also have serious side effects, including increased risk for infection, flu-like symptoms, and burning of the skin.
“Powerful anti-inflammatories can change a number of pathways in the immune system,” said Grace McComsey, MD, who leads the long COVID RECOVER study at University Hospitals Health System in Cleveland, Ohio. Anti-inflammatories hold promise but, Dr. McComsey said, “some are more toxic with many side effects, so even if they work, there’s still a question about who should take them.”
Still, other anti-inflammatories that could work don’t have as many side effects. For example, a study published in The Lancet Infectious Diseases found that the diabetes drug metformin reduced a patient’s risk for long COVID up to 40% when the drug was taken during the acute stage.
Metformin, compared to other anti-inflammatories (also known as immune modulators), is an inexpensive and widely available drug with relatively few side effects compared with other medications.
#5: Serotonin levels — and selective serotonin reuptake inhibitors (SSRIs) — may be keys to unlocking long COVID
One of the most groundbreaking studies of the year came last November. A study published in the journal Cell found lower circulating serotonin levels in patents with long COVID than in those who did not have the condition. The study also found that the SSRI fluoxetine improved cognitive function in rat models infected with the virus.
Researchers found that the reduction in serotonin levels was partially caused by the body’s inability to absorb tryptophan, an amino acid that’s a precursor to serotonin. Overactivated blood platelets may also have played a role.
Michael Peluso, MD, an assistant research professor of infectious medicine at the UCSF School of Medicine, San Francisco, California, hopes to take the finding a step further, investigating whether increased serotonin levels in patients with long COVID will lead to improvements in symptoms.
“What we need now is a good clinical trial to see whether altering levels of serotonin in people with long COVID will lead to symptom relief,” Dr. Peluso said last month in an interview with this news organization.
If patients show an improvement in symptoms, then the next step is looking into whether SSRIs boost serotonin levels in patients and, as a result, reduce their symptoms.
A version of this article appeared on Medscape.com.
With a number of large-scale clinical trials underway and researchers on the hunt for new therapies, long COVID scientists are hopeful that this is the year patients — and doctors who care for them — will finally see improvements in treating their symptoms.
Here are five bold predictions — all based on encouraging research — that could happen in 2024. At the very least, they are promising signs of progress against a debilitating and frustrating disease.
#1: We’ll gain a better understanding of each long COVID phenotype
This past year, a wide breadth of research began showing that long COVID can be defined by a number of different disease phenotypes that present a range of symptoms.
Researchers identified four clinical phenotypes: Chronic fatigue-like syndrome, headache, and memory loss; respiratory syndrome, which includes cough and difficulty breathing; chronic pain; and neurosensorial syndrome, which causes an altered sense of taste and smell.
Identifying specific diagnostic criteria for each phenotype would lead to better health outcomes for patients instead of treating them as if it were a “one-size-fits-all disease,” said Nisha Viswanathan, MD, director of the long COVID program at UCLA Health, Los Angeles, California.
Ultimately, she hopes that this year her patients will receive treatments based on the type of long COVID they’re personally experiencing, and the symptoms they have, leading to improved health outcomes and more rapid relief.
“Many new medications are focused on different pathways of long COVID, and the challenge becomes which drug is the right drug for each treatment,” said Dr. Viswanathan.
#2: Monoclonal antibodies may change the game
We’re starting to have a better understanding that what’s been called “viral persistence” as a main cause of long COVID may potentially be treated with monoclonal antibodies. These are antibodies produced by cloning unique white blood cells to target the circulating spike proteins in the blood that hang out in viral reservoirs and cause the immune system to react as if it’s still fighting acute COVID-19.
Smaller-scale studies have already shown promising results. A January 2024 study published in The American Journal of Emergency Medicine followed three patients who completely recovered from long COVID after taking monoclonal antibodies. “Remission occurred despite dissimilar past histories, sex, age, and illness duration,” wrote the study authors.
Larger clinical trials are underway at the University of California, San Francisco, California, to test targeted monoclonal antibodies. If the results of the larger study show that monoclonal antibodies are beneficial, then it could be a game changer for a large swath of patients around the world, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.
“The idea is that the downstream damage caused by viral persistence will resolve itself once you wipe out the virus,” said Dr. Putrino.
#3: Paxlovid could prove effective for long COVID
The US Food and Drug Administration granted approval for Paxlovid last May for the treatment of mild to moderate COVID-19 in adults at a high risk for severe disease. The medication is made up of two drugs packaged together. The first, nirmatrelvir, works by blocking a key enzyme required for virus replication. The second, ritonavir, is an antiviral that’s been used in patients with HIV and helps boost levels of antivirals in the body.
In a large-scale trial headed up by Dr. Putrino and his team, the oral antiviral is being studied for use in the post-viral stage in patients who test negative for acute COVID-19 but have persisting symptoms of long COVID.
Similar to monoclonal antibodies, the idea is to quell viral persistence. If patients have long COVID because they can’t clear SAR-CoV-2 from their bodies, Paxlovid could help. But unlike monoclonal antibodies that quash the virus, Paxlovid stops the virus from replicating. It’s a different mechanism with the same end goal.
It’s been a controversial treatment because it’s life-changing for some patients and ineffective for others. In addition, it can cause a range of side effects such as diarrhea, nausea, vomiting, and an impaired sense of taste. The goal of the trial is to see which patients with long COVID are most likely to benefit from the treatment.
#4: Anti-inflammatories like metformin could prove useful
Many of the inflammatory markers persistent in patients with long COVID were similarly present in patients with autoimmune diseases like rheumatoid arthritis, according to a July 2023 study published in JAMA.
The hope is that anti-inflammatory medications may be used to reduce inflammation causing long COVID symptoms. But drugs used to treat rheumatoid arthritis like abatacept and infliximabcan also have serious side effects, including increased risk for infection, flu-like symptoms, and burning of the skin.
“Powerful anti-inflammatories can change a number of pathways in the immune system,” said Grace McComsey, MD, who leads the long COVID RECOVER study at University Hospitals Health System in Cleveland, Ohio. Anti-inflammatories hold promise but, Dr. McComsey said, “some are more toxic with many side effects, so even if they work, there’s still a question about who should take them.”
Still, other anti-inflammatories that could work don’t have as many side effects. For example, a study published in The Lancet Infectious Diseases found that the diabetes drug metformin reduced a patient’s risk for long COVID up to 40% when the drug was taken during the acute stage.
Metformin, compared to other anti-inflammatories (also known as immune modulators), is an inexpensive and widely available drug with relatively few side effects compared with other medications.
#5: Serotonin levels — and selective serotonin reuptake inhibitors (SSRIs) — may be keys to unlocking long COVID
One of the most groundbreaking studies of the year came last November. A study published in the journal Cell found lower circulating serotonin levels in patents with long COVID than in those who did not have the condition. The study also found that the SSRI fluoxetine improved cognitive function in rat models infected with the virus.
Researchers found that the reduction in serotonin levels was partially caused by the body’s inability to absorb tryptophan, an amino acid that’s a precursor to serotonin. Overactivated blood platelets may also have played a role.
Michael Peluso, MD, an assistant research professor of infectious medicine at the UCSF School of Medicine, San Francisco, California, hopes to take the finding a step further, investigating whether increased serotonin levels in patients with long COVID will lead to improvements in symptoms.
“What we need now is a good clinical trial to see whether altering levels of serotonin in people with long COVID will lead to symptom relief,” Dr. Peluso said last month in an interview with this news organization.
If patients show an improvement in symptoms, then the next step is looking into whether SSRIs boost serotonin levels in patients and, as a result, reduce their symptoms.
A version of this article appeared on Medscape.com.
With a number of large-scale clinical trials underway and researchers on the hunt for new therapies, long COVID scientists are hopeful that this is the year patients — and doctors who care for them — will finally see improvements in treating their symptoms.
Here are five bold predictions — all based on encouraging research — that could happen in 2024. At the very least, they are promising signs of progress against a debilitating and frustrating disease.
#1: We’ll gain a better understanding of each long COVID phenotype
This past year, a wide breadth of research began showing that long COVID can be defined by a number of different disease phenotypes that present a range of symptoms.
Researchers identified four clinical phenotypes: Chronic fatigue-like syndrome, headache, and memory loss; respiratory syndrome, which includes cough and difficulty breathing; chronic pain; and neurosensorial syndrome, which causes an altered sense of taste and smell.
Identifying specific diagnostic criteria for each phenotype would lead to better health outcomes for patients instead of treating them as if it were a “one-size-fits-all disease,” said Nisha Viswanathan, MD, director of the long COVID program at UCLA Health, Los Angeles, California.
Ultimately, she hopes that this year her patients will receive treatments based on the type of long COVID they’re personally experiencing, and the symptoms they have, leading to improved health outcomes and more rapid relief.
“Many new medications are focused on different pathways of long COVID, and the challenge becomes which drug is the right drug for each treatment,” said Dr. Viswanathan.
#2: Monoclonal antibodies may change the game
We’re starting to have a better understanding that what’s been called “viral persistence” as a main cause of long COVID may potentially be treated with monoclonal antibodies. These are antibodies produced by cloning unique white blood cells to target the circulating spike proteins in the blood that hang out in viral reservoirs and cause the immune system to react as if it’s still fighting acute COVID-19.
Smaller-scale studies have already shown promising results. A January 2024 study published in The American Journal of Emergency Medicine followed three patients who completely recovered from long COVID after taking monoclonal antibodies. “Remission occurred despite dissimilar past histories, sex, age, and illness duration,” wrote the study authors.
Larger clinical trials are underway at the University of California, San Francisco, California, to test targeted monoclonal antibodies. If the results of the larger study show that monoclonal antibodies are beneficial, then it could be a game changer for a large swath of patients around the world, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.
“The idea is that the downstream damage caused by viral persistence will resolve itself once you wipe out the virus,” said Dr. Putrino.
#3: Paxlovid could prove effective for long COVID
The US Food and Drug Administration granted approval for Paxlovid last May for the treatment of mild to moderate COVID-19 in adults at a high risk for severe disease. The medication is made up of two drugs packaged together. The first, nirmatrelvir, works by blocking a key enzyme required for virus replication. The second, ritonavir, is an antiviral that’s been used in patients with HIV and helps boost levels of antivirals in the body.
In a large-scale trial headed up by Dr. Putrino and his team, the oral antiviral is being studied for use in the post-viral stage in patients who test negative for acute COVID-19 but have persisting symptoms of long COVID.
Similar to monoclonal antibodies, the idea is to quell viral persistence. If patients have long COVID because they can’t clear SAR-CoV-2 from their bodies, Paxlovid could help. But unlike monoclonal antibodies that quash the virus, Paxlovid stops the virus from replicating. It’s a different mechanism with the same end goal.
It’s been a controversial treatment because it’s life-changing for some patients and ineffective for others. In addition, it can cause a range of side effects such as diarrhea, nausea, vomiting, and an impaired sense of taste. The goal of the trial is to see which patients with long COVID are most likely to benefit from the treatment.
#4: Anti-inflammatories like metformin could prove useful
Many of the inflammatory markers persistent in patients with long COVID were similarly present in patients with autoimmune diseases like rheumatoid arthritis, according to a July 2023 study published in JAMA.
The hope is that anti-inflammatory medications may be used to reduce inflammation causing long COVID symptoms. But drugs used to treat rheumatoid arthritis like abatacept and infliximabcan also have serious side effects, including increased risk for infection, flu-like symptoms, and burning of the skin.
“Powerful anti-inflammatories can change a number of pathways in the immune system,” said Grace McComsey, MD, who leads the long COVID RECOVER study at University Hospitals Health System in Cleveland, Ohio. Anti-inflammatories hold promise but, Dr. McComsey said, “some are more toxic with many side effects, so even if they work, there’s still a question about who should take them.”
Still, other anti-inflammatories that could work don’t have as many side effects. For example, a study published in The Lancet Infectious Diseases found that the diabetes drug metformin reduced a patient’s risk for long COVID up to 40% when the drug was taken during the acute stage.
Metformin, compared to other anti-inflammatories (also known as immune modulators), is an inexpensive and widely available drug with relatively few side effects compared with other medications.
#5: Serotonin levels — and selective serotonin reuptake inhibitors (SSRIs) — may be keys to unlocking long COVID
One of the most groundbreaking studies of the year came last November. A study published in the journal Cell found lower circulating serotonin levels in patents with long COVID than in those who did not have the condition. The study also found that the SSRI fluoxetine improved cognitive function in rat models infected with the virus.
Researchers found that the reduction in serotonin levels was partially caused by the body’s inability to absorb tryptophan, an amino acid that’s a precursor to serotonin. Overactivated blood platelets may also have played a role.
Michael Peluso, MD, an assistant research professor of infectious medicine at the UCSF School of Medicine, San Francisco, California, hopes to take the finding a step further, investigating whether increased serotonin levels in patients with long COVID will lead to improvements in symptoms.
“What we need now is a good clinical trial to see whether altering levels of serotonin in people with long COVID will lead to symptom relief,” Dr. Peluso said last month in an interview with this news organization.
If patients show an improvement in symptoms, then the next step is looking into whether SSRIs boost serotonin levels in patients and, as a result, reduce their symptoms.
A version of this article appeared on Medscape.com.
Think Outside the Traditional Toolbox to Treat Itch
ORLANDO — “Itch may not be as sexy as Mohs surgery or aesthetic procedures,” but treating it is important and meaningful to patients, particularly those who’ve found little relief previously, Shawn G. Kwatra, MD, said at the annual ODAC Dermatology, Aesthetic & Surgery Conference.
In doctors’ defense, it can be highly challenging to know which approach is optimal for each individual with pruritus, added Dr. Kwatra, associate professor of dermatology at Johns Hopkins University, Baltimore, Maryland.
Cooling agents, topical capsaicin, topical anesthetics like pramoxine 1%, various forms of lidocaine, strontium, opioid modulators like naltrexone, oral Janus kinase inhibitor (JAK) inhibitors, and medical marijuana are among some of the “outside the box” tools in Dr. Kwatra’s itch toolbox.
Often a Medical Puzzle
Frequently, patients come to the dermatologist complaining of itch, “but you don’t see much on their skin.” After a trial of antihistamines, and some topical steroids, the doctor might put up their hands and think: I tried, but I don’t know what else to do. “This actually happens a lot,” said Dr. Kwatra, who is also director of the Johns Hopkins Itch Center.
This means itch can frustrate providers as well. But for patients, the impact on their quality of life can be on the same level as recovering from a stroke or living with heart failure, Dr. Kwatra said. Finding relief for their itch is where “we can make a big difference for patients.”
Consider Cooling Agents
Many of these therapies are inexpensive and widely available. Cooling agents like menthol, camphor, or calamine can reduce activity of the transient receptor potential (TRP) channels in the skin associated with itch. This ion channel also senses temperature, pressure, and other sensations.
Another option is topical capsaicin, which works through the same ion channels. It binds to the TRPV1 receptors in sensory nerve fibers and causes desensitization. Initially, four to six applications a day are required to reduce itch. After that, patients can apply the medication less frequently. “You have to tell folks we know it’s going to work, but it’s going to burn a lot initially,” Dr. Kwatra said. “In real world practice, I’m not using it often.”
A 1.8% capsaicin patch, approved for treating postherpetic neuralgia, can be used to treat pruritus as well. “You put the patch on for one hour and you can have a true clinical response,” he noted.
Another option for itch relief, the topical anesthetic pramoxine 1%, “is probably underutilized for our patients,” Dr. Kwatra said. Pramoxine 1% works fast — as quickly as 2 minutes — and lasts up to 8 hours and is well-tolerated with low toxicity, he added. The agent is applied three to four times a day and relieves itch by reducing the transmembrane permeability of sodium ions on the skin. “This is something widely available and cheap.”
Lidocaine, another topical anesthetic, is available compounded, over the counter, and as a spray or patch. “I would be careful before you use high doses, like 10%” because of tolerability issues, Dr. Kwatra cautioned. He generally starts with lower concentrations.
Topical strontium is really interesting as a strategy, Dr. Kwatra said. Strontium is a soft, white metal that competes with calcium for receptor binding. There are over-the-counter formulations available as a scalp solution or lotion, which, he said, “are ways to go with more episodic itching.”
Topical oatmeal can also relieve itch in some patients. “There is actually some good scientific evidence for topical oatmeal preparations,” he said.
Steroid-Sparing Novel Topicals
Topical ruxolitinib (a JAK inhibitor approved for atopic dermatitis and vitiligo); topical roflumilast (a phosphodiesterase-4 inhibitor) and topical tapinarof (an aryl hydrocarbon receptor agonist), both approved for treating psoriasis; and the atopic dermatitis drug crisaborole fall into this category of topicals with potential for treating itch, he said, noting that use for treating itch is off label.
Off-label use of biologic agents are also possible treatment options for itch, dupilumab and tralokinumab, both US Food and Drug Administration (FDA)–approved for treating atopic dermatitis. Emerging agents that may prove useful for treating itch include lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab, he said.
In terms of oral therapies, the FDA has approved two oral JAK inhibitors for atopic dermatitis, abrocitinib and upadacitinib, which could prove useful for itch as an off-label indication, according to Dr. Kwatra.
Naltrexone Off Label
An emerging therapeutic concept for treating itch is using an opioid antagonist like naltrexone. Morphine causes more itch, so the theory is a reversal agent might help reduce it. The challenge is that naltrexone only comes as a 50 mg tablet, “and I find the high dose makes people nauseous and vomit,” he added.
Don’t Forget Devices
He referred to a “great paper” that he said has been “totally overlooked,” published in 2001, which evaluated a device that stimulates C fibers in the skin to reduce itch. In the study, 19 patients used the device to treat local areas 20 minutes daily for 5 weeks. Punch biopsies of the affected areas were taken at baseline and after treatment. Mean itch ratings decreased from 78% to 42%, and the number of immunoreactive nerve fibers in the epidermis decreased by 40% at the end of treatment.
“Electrical neurostimulation is better for localized pruritus. There is limited case series evidence, but it’s something to think about,” Dr. Kwatra said.
He and his colleagues also have a case study in press that explored the use of injected botulinum toxin to relieve recalcitrant, chronic itch in a 65-year-old man “who failed everything.”
Dr. Kwatra is a consultant or advisory board member for AbbVie, Amgen, Arcutis Biotherapeutics, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi.
A version of this article appeared on Medscape.com.
ORLANDO — “Itch may not be as sexy as Mohs surgery or aesthetic procedures,” but treating it is important and meaningful to patients, particularly those who’ve found little relief previously, Shawn G. Kwatra, MD, said at the annual ODAC Dermatology, Aesthetic & Surgery Conference.
In doctors’ defense, it can be highly challenging to know which approach is optimal for each individual with pruritus, added Dr. Kwatra, associate professor of dermatology at Johns Hopkins University, Baltimore, Maryland.
Cooling agents, topical capsaicin, topical anesthetics like pramoxine 1%, various forms of lidocaine, strontium, opioid modulators like naltrexone, oral Janus kinase inhibitor (JAK) inhibitors, and medical marijuana are among some of the “outside the box” tools in Dr. Kwatra’s itch toolbox.
Often a Medical Puzzle
Frequently, patients come to the dermatologist complaining of itch, “but you don’t see much on their skin.” After a trial of antihistamines, and some topical steroids, the doctor might put up their hands and think: I tried, but I don’t know what else to do. “This actually happens a lot,” said Dr. Kwatra, who is also director of the Johns Hopkins Itch Center.
This means itch can frustrate providers as well. But for patients, the impact on their quality of life can be on the same level as recovering from a stroke or living with heart failure, Dr. Kwatra said. Finding relief for their itch is where “we can make a big difference for patients.”
Consider Cooling Agents
Many of these therapies are inexpensive and widely available. Cooling agents like menthol, camphor, or calamine can reduce activity of the transient receptor potential (TRP) channels in the skin associated with itch. This ion channel also senses temperature, pressure, and other sensations.
Another option is topical capsaicin, which works through the same ion channels. It binds to the TRPV1 receptors in sensory nerve fibers and causes desensitization. Initially, four to six applications a day are required to reduce itch. After that, patients can apply the medication less frequently. “You have to tell folks we know it’s going to work, but it’s going to burn a lot initially,” Dr. Kwatra said. “In real world practice, I’m not using it often.”
A 1.8% capsaicin patch, approved for treating postherpetic neuralgia, can be used to treat pruritus as well. “You put the patch on for one hour and you can have a true clinical response,” he noted.
Another option for itch relief, the topical anesthetic pramoxine 1%, “is probably underutilized for our patients,” Dr. Kwatra said. Pramoxine 1% works fast — as quickly as 2 minutes — and lasts up to 8 hours and is well-tolerated with low toxicity, he added. The agent is applied three to four times a day and relieves itch by reducing the transmembrane permeability of sodium ions on the skin. “This is something widely available and cheap.”
Lidocaine, another topical anesthetic, is available compounded, over the counter, and as a spray or patch. “I would be careful before you use high doses, like 10%” because of tolerability issues, Dr. Kwatra cautioned. He generally starts with lower concentrations.
Topical strontium is really interesting as a strategy, Dr. Kwatra said. Strontium is a soft, white metal that competes with calcium for receptor binding. There are over-the-counter formulations available as a scalp solution or lotion, which, he said, “are ways to go with more episodic itching.”
Topical oatmeal can also relieve itch in some patients. “There is actually some good scientific evidence for topical oatmeal preparations,” he said.
Steroid-Sparing Novel Topicals
Topical ruxolitinib (a JAK inhibitor approved for atopic dermatitis and vitiligo); topical roflumilast (a phosphodiesterase-4 inhibitor) and topical tapinarof (an aryl hydrocarbon receptor agonist), both approved for treating psoriasis; and the atopic dermatitis drug crisaborole fall into this category of topicals with potential for treating itch, he said, noting that use for treating itch is off label.
Off-label use of biologic agents are also possible treatment options for itch, dupilumab and tralokinumab, both US Food and Drug Administration (FDA)–approved for treating atopic dermatitis. Emerging agents that may prove useful for treating itch include lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab, he said.
In terms of oral therapies, the FDA has approved two oral JAK inhibitors for atopic dermatitis, abrocitinib and upadacitinib, which could prove useful for itch as an off-label indication, according to Dr. Kwatra.
Naltrexone Off Label
An emerging therapeutic concept for treating itch is using an opioid antagonist like naltrexone. Morphine causes more itch, so the theory is a reversal agent might help reduce it. The challenge is that naltrexone only comes as a 50 mg tablet, “and I find the high dose makes people nauseous and vomit,” he added.
Don’t Forget Devices
He referred to a “great paper” that he said has been “totally overlooked,” published in 2001, which evaluated a device that stimulates C fibers in the skin to reduce itch. In the study, 19 patients used the device to treat local areas 20 minutes daily for 5 weeks. Punch biopsies of the affected areas were taken at baseline and after treatment. Mean itch ratings decreased from 78% to 42%, and the number of immunoreactive nerve fibers in the epidermis decreased by 40% at the end of treatment.
“Electrical neurostimulation is better for localized pruritus. There is limited case series evidence, but it’s something to think about,” Dr. Kwatra said.
He and his colleagues also have a case study in press that explored the use of injected botulinum toxin to relieve recalcitrant, chronic itch in a 65-year-old man “who failed everything.”
Dr. Kwatra is a consultant or advisory board member for AbbVie, Amgen, Arcutis Biotherapeutics, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi.
A version of this article appeared on Medscape.com.
ORLANDO — “Itch may not be as sexy as Mohs surgery or aesthetic procedures,” but treating it is important and meaningful to patients, particularly those who’ve found little relief previously, Shawn G. Kwatra, MD, said at the annual ODAC Dermatology, Aesthetic & Surgery Conference.
In doctors’ defense, it can be highly challenging to know which approach is optimal for each individual with pruritus, added Dr. Kwatra, associate professor of dermatology at Johns Hopkins University, Baltimore, Maryland.
Cooling agents, topical capsaicin, topical anesthetics like pramoxine 1%, various forms of lidocaine, strontium, opioid modulators like naltrexone, oral Janus kinase inhibitor (JAK) inhibitors, and medical marijuana are among some of the “outside the box” tools in Dr. Kwatra’s itch toolbox.
Often a Medical Puzzle
Frequently, patients come to the dermatologist complaining of itch, “but you don’t see much on their skin.” After a trial of antihistamines, and some topical steroids, the doctor might put up their hands and think: I tried, but I don’t know what else to do. “This actually happens a lot,” said Dr. Kwatra, who is also director of the Johns Hopkins Itch Center.
This means itch can frustrate providers as well. But for patients, the impact on their quality of life can be on the same level as recovering from a stroke or living with heart failure, Dr. Kwatra said. Finding relief for their itch is where “we can make a big difference for patients.”
Consider Cooling Agents
Many of these therapies are inexpensive and widely available. Cooling agents like menthol, camphor, or calamine can reduce activity of the transient receptor potential (TRP) channels in the skin associated with itch. This ion channel also senses temperature, pressure, and other sensations.
Another option is topical capsaicin, which works through the same ion channels. It binds to the TRPV1 receptors in sensory nerve fibers and causes desensitization. Initially, four to six applications a day are required to reduce itch. After that, patients can apply the medication less frequently. “You have to tell folks we know it’s going to work, but it’s going to burn a lot initially,” Dr. Kwatra said. “In real world practice, I’m not using it often.”
A 1.8% capsaicin patch, approved for treating postherpetic neuralgia, can be used to treat pruritus as well. “You put the patch on for one hour and you can have a true clinical response,” he noted.
Another option for itch relief, the topical anesthetic pramoxine 1%, “is probably underutilized for our patients,” Dr. Kwatra said. Pramoxine 1% works fast — as quickly as 2 minutes — and lasts up to 8 hours and is well-tolerated with low toxicity, he added. The agent is applied three to four times a day and relieves itch by reducing the transmembrane permeability of sodium ions on the skin. “This is something widely available and cheap.”
Lidocaine, another topical anesthetic, is available compounded, over the counter, and as a spray or patch. “I would be careful before you use high doses, like 10%” because of tolerability issues, Dr. Kwatra cautioned. He generally starts with lower concentrations.
Topical strontium is really interesting as a strategy, Dr. Kwatra said. Strontium is a soft, white metal that competes with calcium for receptor binding. There are over-the-counter formulations available as a scalp solution or lotion, which, he said, “are ways to go with more episodic itching.”
Topical oatmeal can also relieve itch in some patients. “There is actually some good scientific evidence for topical oatmeal preparations,” he said.
Steroid-Sparing Novel Topicals
Topical ruxolitinib (a JAK inhibitor approved for atopic dermatitis and vitiligo); topical roflumilast (a phosphodiesterase-4 inhibitor) and topical tapinarof (an aryl hydrocarbon receptor agonist), both approved for treating psoriasis; and the atopic dermatitis drug crisaborole fall into this category of topicals with potential for treating itch, he said, noting that use for treating itch is off label.
Off-label use of biologic agents are also possible treatment options for itch, dupilumab and tralokinumab, both US Food and Drug Administration (FDA)–approved for treating atopic dermatitis. Emerging agents that may prove useful for treating itch include lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab, he said.
In terms of oral therapies, the FDA has approved two oral JAK inhibitors for atopic dermatitis, abrocitinib and upadacitinib, which could prove useful for itch as an off-label indication, according to Dr. Kwatra.
Naltrexone Off Label
An emerging therapeutic concept for treating itch is using an opioid antagonist like naltrexone. Morphine causes more itch, so the theory is a reversal agent might help reduce it. The challenge is that naltrexone only comes as a 50 mg tablet, “and I find the high dose makes people nauseous and vomit,” he added.
Don’t Forget Devices
He referred to a “great paper” that he said has been “totally overlooked,” published in 2001, which evaluated a device that stimulates C fibers in the skin to reduce itch. In the study, 19 patients used the device to treat local areas 20 minutes daily for 5 weeks. Punch biopsies of the affected areas were taken at baseline and after treatment. Mean itch ratings decreased from 78% to 42%, and the number of immunoreactive nerve fibers in the epidermis decreased by 40% at the end of treatment.
“Electrical neurostimulation is better for localized pruritus. There is limited case series evidence, but it’s something to think about,” Dr. Kwatra said.
He and his colleagues also have a case study in press that explored the use of injected botulinum toxin to relieve recalcitrant, chronic itch in a 65-year-old man “who failed everything.”
Dr. Kwatra is a consultant or advisory board member for AbbVie, Amgen, Arcutis Biotherapeutics, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi.
A version of this article appeared on Medscape.com.
FROM ODAC 2024
Cutaneous lupus, dermatomyositis: Excitement growing around emerging therapies
ORLANDO, FLORIDA — Advances in treating medical conditions rarely emerge in a straight line. Oftentimes, progress comes in fits and starts, and therapies to treat cutaneous lupus erythematosus (CLE) and dermatomyositis are no exception.
Beyond approved treatments that deserve more attention, like belimumab, approved by the Food and Drug Administration (FDA) for systemic lupus erythematosus (SLE) in 2011, and Octagam 10%, an intravenous immune globulin (IVIG) preparation approved for dermatomyositis in 2021, anticipation is growing for emerging therapies and their potential to provide relief to patients, Anthony Fernandez, MD, PhD, said at the ODAC Dermatology, Aesthetic & Surgical Conference. The tyrosine kinase 2 (TYK2) inhibitor deucravacitinib, Janus kinase (JAK) inhibitors brepocitinib and baricitinib, and the monoclonal antibody anifrolumab, he noted, are prime examples.
“. In my opinion, this is the start of what will be the most exciting decade in the history of these two diseases,” said Dr. Fernandez, director of medical dermatology at the Cleveland Clinic.
Emerging Treatments for Cutaneous Lupus
Although SLE can involve many organ systems, the skin is one of the most affected. There are specific cutaneous lesions categorized as either acute cutaneous lupus, subacute cutaneous lupus, or chronic cutaneous lupus.
The oral TYK2 inhibitor deucravacitinib, for example, should be able to dampen interleukin responses in people with CLE, Dr. Fernandez said. Deucravacitinib was approved by the FDA to treat psoriasis in September 2022.
A phase 2 study published in 2023 focused on this agent for relief of systemic lupus. Improvements in cutaneous disease were a secondary endpoint. The trial demonstrated that the patients treated with deucravacitinib achieved a 56%-70% CLASI-50 response, depending on dosing, compared with a 17% response among those on placebo at week 48.
Based on the trial results, recruitment has begun for a phase 2 trial to evaluate deucravacitinib, compared with placebo, in patients with discoid and/or subacute cutaneous lupus. “This may be another medicine we have available to give to any of our patients with cutaneous lupus,” Dr. Fernandez said.
Anifrolumab Appears Promising
The FDA approval of anifrolumab, a type I interferon (IFN) receptor antagonist, for treating moderate to severe SLE in July 2021, for example, is good news for dermatologists and their patients, added Dr. Fernandez. “Almost immediately after approval, case studies showed marked improvement in patients with refractory cutaneous lupus.” While the therapy was approved for treating systemic lupus, it allows for off-label treatment of the cutaneous predominant form of the disease, he said.
Furthermore, the manufacturer of anifrolumab, AstraZeneca, is launching the LAVENDER clinical trial to assess the monoclonal antibody specifically for treating CLE. “This is a big deal because we may be able to prescribe anifrolumab for our cutaneous lupus patients who don’t have systemic lupus,” Dr. Fernandez said.
Phase 3 data supported use the of anifrolumab in systemic lupus, including the TULIP-2 trial, which demonstrated its superiority to placebo for reducing severity of systemic disease and lowering corticosteroid use. A study published in March 2023 of 11 patients showed that they had a “very fast response” to the agent, Dr. Fernandez said, with a 50% or greater improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score reached by all participants at week 16. Improvements of 50% or more in this scoring system are considered clinically meaningful, he added.
Upcoming Dermatomyositis Treatments
Why highlight emerging therapies for CLE and dermatomyositis in the same ODAC presentation? Although distinct conditions, these autoimmune conditions are both mediated by type 1 IFN inflammation.
Dermatomyositis is a relatively rare immune-mediated disease that most commonly affects the skin and muscle. Doctors score disease presentation, activity, and clinical improvements on a scale similar to CLASI for cutaneous lupus, the CDASI or Cutaneous Dermatomyositis Disease Area and Severity Index. Among people with CDASI activity scores of at least 14, which is the threshold for moderate to severe disease, a 20% improvement is clinically meaningful, Dr. Fernandez said. In addition, a 40% or greater improvement correlates with significant improvements in quality of life.
There is now more evidence for the use of IVIG to treat dermatomyositis. “Among those of us who treat dermatomyositis on a regular basis, we believe IVIG is the most potent treatment. We’ve known that for a long time,” Dr. Fernandez said.
Despite this tenet, for years, there was only one placebo-controlled trial, published in 1993, that evaluated IVIG treatment for dermatomyositis, and it included only 15 participants. That was until October 2022, he said, when the New England Journal of Medicine published a study comparing a specific brand of IVIG (Octagam) with placebo in 95 people with dermatomyositis.
In the study, 79% of participants treated with IVIG had a total improvement score of at least 20 (minimal improvement), the primary endpoint, at 16 weeks, compared with 44% of those receiving a placebo. Those treated with IVIG also had significant improvements in the CDASI score, a secondary endpoint, compared with those on placebo, he said.
Based on results of this trial, the FDA approved Octagam 10% for dermatomyositis in adults. Dr. Fernandez noted the approval is restricted to the brand of IVIG in the trial, not all IVIG products. However, “the FDA approval is most important to us because it gives us ammunition to fight for insurers to approve IVIG when we feel our patients with dermatomyositis need it,” regardless of the brand.
The Potential of JAK1 Inhibitors
An open-label study of the JAK inhibitor tofacitinib, published in December 2020, showed that mean changes in CDASI activity scores at 12 weeks were statistically significant compared with baseline in 10 people with dermatomyositis. “The importance of this study is that it is proof of concept that JAK inhibition can be effective for treating dermatomyositis, especially with active skin disease,” Dr. Fernandez said.
In addition, two large phase 3 trials are evaluating JAK inhibitor safety and efficacy for treating dermatomyositis. One is the VALOR trial, currently recruiting people with recalcitrant dermatomyositis to evaluate treatment with brepocitinib. Researchers in France are looking at another JAK inhibitor, baricitinib, for treating relapsing or treatment-naive dermatomyositis. Recruitment for the BIRD clinical trial is ongoing.
Monoclonal Antibody Showing Promise
“When it comes to looking specifically at dermatomyositis cutaneous disease, it’s been found that the levels of IFN beta correlate best with not only lesional skin type 1 IFN inflammatory signatures but also overall clinical disease activity,” Dr. Fernandez said. This correlation is stronger than for any other IFN-1-type cytokine active in the disorder.
“Perhaps blocking IFN beta might be best way to get control of dermatomyositis activity,” he added.
With that in mind, a phase 2 trial of dazukibart presented at the American Academy of Dermatology 2023 annual meeting highlighted the promise of this agent that targets type 1 IFN beta.
The primary endpoint was improvement in CDASI at 12 weeks. “This medication has remarkable efficacy,” Dr. Fernandez said. “We were one of the sites for this trial. Despite being blinded, there was no question about who was receiving drug and who was receiving placebo.”
“A minimal clinical improvement in disease activity was seen in more than 90%, so almost every patient who received this medication had meaningful improvement,” he added.
Based on the results, the manufacturer, Pfizer, is recruiting participants for a phase 3 trial to further assess dazukibart in dermatomyositis and polymyositis. Dr. Fernandez said, “This is a story you should pay attention to if you treat any dermatomyositis patients at all.”
Regarding these emerging therapies for CLE and dermatomyositis, “This looks very much like the early days of psoriasis, in the early 2000s, when there was a lot of activity developing treatments,” Dr. Fernandez said. “I will predict that within 10 years, we will have multiple novel agents available that will probably work better than anything we have today.”
Dr. Fernandez reported receiving grant and/or research support from Alexion, Incyte, Mallinckrodt Pharmaceuticals, Novartis, Pfizer, and Priovant Therapeutics; acting as a consultant or advisory board member for AbbVie, Biogen, Mallinckrodt Pharmaceuticals; and being a member of the speaker bureau or receiving honoraria for non-CME from AbbVie, Kyowa Kirin, and Mallinckrodt Pharmaceuticals.
A version of this article appeared on Medscape.com.
ORLANDO, FLORIDA — Advances in treating medical conditions rarely emerge in a straight line. Oftentimes, progress comes in fits and starts, and therapies to treat cutaneous lupus erythematosus (CLE) and dermatomyositis are no exception.
Beyond approved treatments that deserve more attention, like belimumab, approved by the Food and Drug Administration (FDA) for systemic lupus erythematosus (SLE) in 2011, and Octagam 10%, an intravenous immune globulin (IVIG) preparation approved for dermatomyositis in 2021, anticipation is growing for emerging therapies and their potential to provide relief to patients, Anthony Fernandez, MD, PhD, said at the ODAC Dermatology, Aesthetic & Surgical Conference. The tyrosine kinase 2 (TYK2) inhibitor deucravacitinib, Janus kinase (JAK) inhibitors brepocitinib and baricitinib, and the monoclonal antibody anifrolumab, he noted, are prime examples.
“. In my opinion, this is the start of what will be the most exciting decade in the history of these two diseases,” said Dr. Fernandez, director of medical dermatology at the Cleveland Clinic.
Emerging Treatments for Cutaneous Lupus
Although SLE can involve many organ systems, the skin is one of the most affected. There are specific cutaneous lesions categorized as either acute cutaneous lupus, subacute cutaneous lupus, or chronic cutaneous lupus.
The oral TYK2 inhibitor deucravacitinib, for example, should be able to dampen interleukin responses in people with CLE, Dr. Fernandez said. Deucravacitinib was approved by the FDA to treat psoriasis in September 2022.
A phase 2 study published in 2023 focused on this agent for relief of systemic lupus. Improvements in cutaneous disease were a secondary endpoint. The trial demonstrated that the patients treated with deucravacitinib achieved a 56%-70% CLASI-50 response, depending on dosing, compared with a 17% response among those on placebo at week 48.
Based on the trial results, recruitment has begun for a phase 2 trial to evaluate deucravacitinib, compared with placebo, in patients with discoid and/or subacute cutaneous lupus. “This may be another medicine we have available to give to any of our patients with cutaneous lupus,” Dr. Fernandez said.
Anifrolumab Appears Promising
The FDA approval of anifrolumab, a type I interferon (IFN) receptor antagonist, for treating moderate to severe SLE in July 2021, for example, is good news for dermatologists and their patients, added Dr. Fernandez. “Almost immediately after approval, case studies showed marked improvement in patients with refractory cutaneous lupus.” While the therapy was approved for treating systemic lupus, it allows for off-label treatment of the cutaneous predominant form of the disease, he said.
Furthermore, the manufacturer of anifrolumab, AstraZeneca, is launching the LAVENDER clinical trial to assess the monoclonal antibody specifically for treating CLE. “This is a big deal because we may be able to prescribe anifrolumab for our cutaneous lupus patients who don’t have systemic lupus,” Dr. Fernandez said.
Phase 3 data supported use the of anifrolumab in systemic lupus, including the TULIP-2 trial, which demonstrated its superiority to placebo for reducing severity of systemic disease and lowering corticosteroid use. A study published in March 2023 of 11 patients showed that they had a “very fast response” to the agent, Dr. Fernandez said, with a 50% or greater improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score reached by all participants at week 16. Improvements of 50% or more in this scoring system are considered clinically meaningful, he added.
Upcoming Dermatomyositis Treatments
Why highlight emerging therapies for CLE and dermatomyositis in the same ODAC presentation? Although distinct conditions, these autoimmune conditions are both mediated by type 1 IFN inflammation.
Dermatomyositis is a relatively rare immune-mediated disease that most commonly affects the skin and muscle. Doctors score disease presentation, activity, and clinical improvements on a scale similar to CLASI for cutaneous lupus, the CDASI or Cutaneous Dermatomyositis Disease Area and Severity Index. Among people with CDASI activity scores of at least 14, which is the threshold for moderate to severe disease, a 20% improvement is clinically meaningful, Dr. Fernandez said. In addition, a 40% or greater improvement correlates with significant improvements in quality of life.
There is now more evidence for the use of IVIG to treat dermatomyositis. “Among those of us who treat dermatomyositis on a regular basis, we believe IVIG is the most potent treatment. We’ve known that for a long time,” Dr. Fernandez said.
Despite this tenet, for years, there was only one placebo-controlled trial, published in 1993, that evaluated IVIG treatment for dermatomyositis, and it included only 15 participants. That was until October 2022, he said, when the New England Journal of Medicine published a study comparing a specific brand of IVIG (Octagam) with placebo in 95 people with dermatomyositis.
In the study, 79% of participants treated with IVIG had a total improvement score of at least 20 (minimal improvement), the primary endpoint, at 16 weeks, compared with 44% of those receiving a placebo. Those treated with IVIG also had significant improvements in the CDASI score, a secondary endpoint, compared with those on placebo, he said.
Based on results of this trial, the FDA approved Octagam 10% for dermatomyositis in adults. Dr. Fernandez noted the approval is restricted to the brand of IVIG in the trial, not all IVIG products. However, “the FDA approval is most important to us because it gives us ammunition to fight for insurers to approve IVIG when we feel our patients with dermatomyositis need it,” regardless of the brand.
The Potential of JAK1 Inhibitors
An open-label study of the JAK inhibitor tofacitinib, published in December 2020, showed that mean changes in CDASI activity scores at 12 weeks were statistically significant compared with baseline in 10 people with dermatomyositis. “The importance of this study is that it is proof of concept that JAK inhibition can be effective for treating dermatomyositis, especially with active skin disease,” Dr. Fernandez said.
In addition, two large phase 3 trials are evaluating JAK inhibitor safety and efficacy for treating dermatomyositis. One is the VALOR trial, currently recruiting people with recalcitrant dermatomyositis to evaluate treatment with brepocitinib. Researchers in France are looking at another JAK inhibitor, baricitinib, for treating relapsing or treatment-naive dermatomyositis. Recruitment for the BIRD clinical trial is ongoing.
Monoclonal Antibody Showing Promise
“When it comes to looking specifically at dermatomyositis cutaneous disease, it’s been found that the levels of IFN beta correlate best with not only lesional skin type 1 IFN inflammatory signatures but also overall clinical disease activity,” Dr. Fernandez said. This correlation is stronger than for any other IFN-1-type cytokine active in the disorder.
“Perhaps blocking IFN beta might be best way to get control of dermatomyositis activity,” he added.
With that in mind, a phase 2 trial of dazukibart presented at the American Academy of Dermatology 2023 annual meeting highlighted the promise of this agent that targets type 1 IFN beta.
The primary endpoint was improvement in CDASI at 12 weeks. “This medication has remarkable efficacy,” Dr. Fernandez said. “We were one of the sites for this trial. Despite being blinded, there was no question about who was receiving drug and who was receiving placebo.”
“A minimal clinical improvement in disease activity was seen in more than 90%, so almost every patient who received this medication had meaningful improvement,” he added.
Based on the results, the manufacturer, Pfizer, is recruiting participants for a phase 3 trial to further assess dazukibart in dermatomyositis and polymyositis. Dr. Fernandez said, “This is a story you should pay attention to if you treat any dermatomyositis patients at all.”
Regarding these emerging therapies for CLE and dermatomyositis, “This looks very much like the early days of psoriasis, in the early 2000s, when there was a lot of activity developing treatments,” Dr. Fernandez said. “I will predict that within 10 years, we will have multiple novel agents available that will probably work better than anything we have today.”
Dr. Fernandez reported receiving grant and/or research support from Alexion, Incyte, Mallinckrodt Pharmaceuticals, Novartis, Pfizer, and Priovant Therapeutics; acting as a consultant or advisory board member for AbbVie, Biogen, Mallinckrodt Pharmaceuticals; and being a member of the speaker bureau or receiving honoraria for non-CME from AbbVie, Kyowa Kirin, and Mallinckrodt Pharmaceuticals.
A version of this article appeared on Medscape.com.
ORLANDO, FLORIDA — Advances in treating medical conditions rarely emerge in a straight line. Oftentimes, progress comes in fits and starts, and therapies to treat cutaneous lupus erythematosus (CLE) and dermatomyositis are no exception.
Beyond approved treatments that deserve more attention, like belimumab, approved by the Food and Drug Administration (FDA) for systemic lupus erythematosus (SLE) in 2011, and Octagam 10%, an intravenous immune globulin (IVIG) preparation approved for dermatomyositis in 2021, anticipation is growing for emerging therapies and their potential to provide relief to patients, Anthony Fernandez, MD, PhD, said at the ODAC Dermatology, Aesthetic & Surgical Conference. The tyrosine kinase 2 (TYK2) inhibitor deucravacitinib, Janus kinase (JAK) inhibitors brepocitinib and baricitinib, and the monoclonal antibody anifrolumab, he noted, are prime examples.
“. In my opinion, this is the start of what will be the most exciting decade in the history of these two diseases,” said Dr. Fernandez, director of medical dermatology at the Cleveland Clinic.
Emerging Treatments for Cutaneous Lupus
Although SLE can involve many organ systems, the skin is one of the most affected. There are specific cutaneous lesions categorized as either acute cutaneous lupus, subacute cutaneous lupus, or chronic cutaneous lupus.
The oral TYK2 inhibitor deucravacitinib, for example, should be able to dampen interleukin responses in people with CLE, Dr. Fernandez said. Deucravacitinib was approved by the FDA to treat psoriasis in September 2022.
A phase 2 study published in 2023 focused on this agent for relief of systemic lupus. Improvements in cutaneous disease were a secondary endpoint. The trial demonstrated that the patients treated with deucravacitinib achieved a 56%-70% CLASI-50 response, depending on dosing, compared with a 17% response among those on placebo at week 48.
Based on the trial results, recruitment has begun for a phase 2 trial to evaluate deucravacitinib, compared with placebo, in patients with discoid and/or subacute cutaneous lupus. “This may be another medicine we have available to give to any of our patients with cutaneous lupus,” Dr. Fernandez said.
Anifrolumab Appears Promising
The FDA approval of anifrolumab, a type I interferon (IFN) receptor antagonist, for treating moderate to severe SLE in July 2021, for example, is good news for dermatologists and their patients, added Dr. Fernandez. “Almost immediately after approval, case studies showed marked improvement in patients with refractory cutaneous lupus.” While the therapy was approved for treating systemic lupus, it allows for off-label treatment of the cutaneous predominant form of the disease, he said.
Furthermore, the manufacturer of anifrolumab, AstraZeneca, is launching the LAVENDER clinical trial to assess the monoclonal antibody specifically for treating CLE. “This is a big deal because we may be able to prescribe anifrolumab for our cutaneous lupus patients who don’t have systemic lupus,” Dr. Fernandez said.
Phase 3 data supported use the of anifrolumab in systemic lupus, including the TULIP-2 trial, which demonstrated its superiority to placebo for reducing severity of systemic disease and lowering corticosteroid use. A study published in March 2023 of 11 patients showed that they had a “very fast response” to the agent, Dr. Fernandez said, with a 50% or greater improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score reached by all participants at week 16. Improvements of 50% or more in this scoring system are considered clinically meaningful, he added.
Upcoming Dermatomyositis Treatments
Why highlight emerging therapies for CLE and dermatomyositis in the same ODAC presentation? Although distinct conditions, these autoimmune conditions are both mediated by type 1 IFN inflammation.
Dermatomyositis is a relatively rare immune-mediated disease that most commonly affects the skin and muscle. Doctors score disease presentation, activity, and clinical improvements on a scale similar to CLASI for cutaneous lupus, the CDASI or Cutaneous Dermatomyositis Disease Area and Severity Index. Among people with CDASI activity scores of at least 14, which is the threshold for moderate to severe disease, a 20% improvement is clinically meaningful, Dr. Fernandez said. In addition, a 40% or greater improvement correlates with significant improvements in quality of life.
There is now more evidence for the use of IVIG to treat dermatomyositis. “Among those of us who treat dermatomyositis on a regular basis, we believe IVIG is the most potent treatment. We’ve known that for a long time,” Dr. Fernandez said.
Despite this tenet, for years, there was only one placebo-controlled trial, published in 1993, that evaluated IVIG treatment for dermatomyositis, and it included only 15 participants. That was until October 2022, he said, when the New England Journal of Medicine published a study comparing a specific brand of IVIG (Octagam) with placebo in 95 people with dermatomyositis.
In the study, 79% of participants treated with IVIG had a total improvement score of at least 20 (minimal improvement), the primary endpoint, at 16 weeks, compared with 44% of those receiving a placebo. Those treated with IVIG also had significant improvements in the CDASI score, a secondary endpoint, compared with those on placebo, he said.
Based on results of this trial, the FDA approved Octagam 10% for dermatomyositis in adults. Dr. Fernandez noted the approval is restricted to the brand of IVIG in the trial, not all IVIG products. However, “the FDA approval is most important to us because it gives us ammunition to fight for insurers to approve IVIG when we feel our patients with dermatomyositis need it,” regardless of the brand.
The Potential of JAK1 Inhibitors
An open-label study of the JAK inhibitor tofacitinib, published in December 2020, showed that mean changes in CDASI activity scores at 12 weeks were statistically significant compared with baseline in 10 people with dermatomyositis. “The importance of this study is that it is proof of concept that JAK inhibition can be effective for treating dermatomyositis, especially with active skin disease,” Dr. Fernandez said.
In addition, two large phase 3 trials are evaluating JAK inhibitor safety and efficacy for treating dermatomyositis. One is the VALOR trial, currently recruiting people with recalcitrant dermatomyositis to evaluate treatment with brepocitinib. Researchers in France are looking at another JAK inhibitor, baricitinib, for treating relapsing or treatment-naive dermatomyositis. Recruitment for the BIRD clinical trial is ongoing.
Monoclonal Antibody Showing Promise
“When it comes to looking specifically at dermatomyositis cutaneous disease, it’s been found that the levels of IFN beta correlate best with not only lesional skin type 1 IFN inflammatory signatures but also overall clinical disease activity,” Dr. Fernandez said. This correlation is stronger than for any other IFN-1-type cytokine active in the disorder.
“Perhaps blocking IFN beta might be best way to get control of dermatomyositis activity,” he added.
With that in mind, a phase 2 trial of dazukibart presented at the American Academy of Dermatology 2023 annual meeting highlighted the promise of this agent that targets type 1 IFN beta.
The primary endpoint was improvement in CDASI at 12 weeks. “This medication has remarkable efficacy,” Dr. Fernandez said. “We were one of the sites for this trial. Despite being blinded, there was no question about who was receiving drug and who was receiving placebo.”
“A minimal clinical improvement in disease activity was seen in more than 90%, so almost every patient who received this medication had meaningful improvement,” he added.
Based on the results, the manufacturer, Pfizer, is recruiting participants for a phase 3 trial to further assess dazukibart in dermatomyositis and polymyositis. Dr. Fernandez said, “This is a story you should pay attention to if you treat any dermatomyositis patients at all.”
Regarding these emerging therapies for CLE and dermatomyositis, “This looks very much like the early days of psoriasis, in the early 2000s, when there was a lot of activity developing treatments,” Dr. Fernandez said. “I will predict that within 10 years, we will have multiple novel agents available that will probably work better than anything we have today.”
Dr. Fernandez reported receiving grant and/or research support from Alexion, Incyte, Mallinckrodt Pharmaceuticals, Novartis, Pfizer, and Priovant Therapeutics; acting as a consultant or advisory board member for AbbVie, Biogen, Mallinckrodt Pharmaceuticals; and being a member of the speaker bureau or receiving honoraria for non-CME from AbbVie, Kyowa Kirin, and Mallinckrodt Pharmaceuticals.
A version of this article appeared on Medscape.com.
FROM ODAC 2024
Dana-Farber Moves to Retract, Correct Dozens of Cancer Papers Amid Allegations
News of the investigation follows a blog post by British molecular biologist Sholto David, MD, who flagged almost 60 papers published between 1997 and 2017 that contained image manipulation and other errors. Some of the papers were published by Dana-Farber’s chief executive officer, Laurie Glimcher, MD, and chief operating officer, William Hahn, MD, on topics including multiple myeloma and immune cells.
Mr. David, who blogs about research integrity, highlighted numerous errors and irregularities, including copying and pasting images across multiple experiments to represent different days within the same experiment, sometimes rotating or stretching images.
In one case, Mr. David equated the manipulation with tactics used by “hapless Chinese papermills” and concluded that “a swathe of research coming out of [Dana-Farber] authored by the most senior researchers and managers appears to be hopelessly corrupt with errors that are obvious from just a cursory reading the papers.”
“Imagine what mistakes might be found in the raw data if anyone was allowed to look!” he wrote.
Barrett Rollins, MD, PhD, Dana-Farber Cancer Institute’s research integrity officer, declined to comment on whether the errors represent scientific misconduct, according to STAT. Rollins told ScienceInsider that the “presence of image discrepancies in a paper is not evidence of an author’s intent to deceive.”
Access to new artificial intelligence tools is making it easier for data sleuths, like Mr. David, to unearth data manipulation and errors.
The current investigation closely follows two other investigations into the published work of Harvard University’s former president, Claudine Gay, and Stanford University’s former president, Marc Tessier-Lavigne, which led both to resign their posts.
A version of this article appeared on Medscape.com.
News of the investigation follows a blog post by British molecular biologist Sholto David, MD, who flagged almost 60 papers published between 1997 and 2017 that contained image manipulation and other errors. Some of the papers were published by Dana-Farber’s chief executive officer, Laurie Glimcher, MD, and chief operating officer, William Hahn, MD, on topics including multiple myeloma and immune cells.
Mr. David, who blogs about research integrity, highlighted numerous errors and irregularities, including copying and pasting images across multiple experiments to represent different days within the same experiment, sometimes rotating or stretching images.
In one case, Mr. David equated the manipulation with tactics used by “hapless Chinese papermills” and concluded that “a swathe of research coming out of [Dana-Farber] authored by the most senior researchers and managers appears to be hopelessly corrupt with errors that are obvious from just a cursory reading the papers.”
“Imagine what mistakes might be found in the raw data if anyone was allowed to look!” he wrote.
Barrett Rollins, MD, PhD, Dana-Farber Cancer Institute’s research integrity officer, declined to comment on whether the errors represent scientific misconduct, according to STAT. Rollins told ScienceInsider that the “presence of image discrepancies in a paper is not evidence of an author’s intent to deceive.”
Access to new artificial intelligence tools is making it easier for data sleuths, like Mr. David, to unearth data manipulation and errors.
The current investigation closely follows two other investigations into the published work of Harvard University’s former president, Claudine Gay, and Stanford University’s former president, Marc Tessier-Lavigne, which led both to resign their posts.
A version of this article appeared on Medscape.com.
News of the investigation follows a blog post by British molecular biologist Sholto David, MD, who flagged almost 60 papers published between 1997 and 2017 that contained image manipulation and other errors. Some of the papers were published by Dana-Farber’s chief executive officer, Laurie Glimcher, MD, and chief operating officer, William Hahn, MD, on topics including multiple myeloma and immune cells.
Mr. David, who blogs about research integrity, highlighted numerous errors and irregularities, including copying and pasting images across multiple experiments to represent different days within the same experiment, sometimes rotating or stretching images.
In one case, Mr. David equated the manipulation with tactics used by “hapless Chinese papermills” and concluded that “a swathe of research coming out of [Dana-Farber] authored by the most senior researchers and managers appears to be hopelessly corrupt with errors that are obvious from just a cursory reading the papers.”
“Imagine what mistakes might be found in the raw data if anyone was allowed to look!” he wrote.
Barrett Rollins, MD, PhD, Dana-Farber Cancer Institute’s research integrity officer, declined to comment on whether the errors represent scientific misconduct, according to STAT. Rollins told ScienceInsider that the “presence of image discrepancies in a paper is not evidence of an author’s intent to deceive.”
Access to new artificial intelligence tools is making it easier for data sleuths, like Mr. David, to unearth data manipulation and errors.
The current investigation closely follows two other investigations into the published work of Harvard University’s former president, Claudine Gay, and Stanford University’s former president, Marc Tessier-Lavigne, which led both to resign their posts.
A version of this article appeared on Medscape.com.
Association Between LDL-C and Androgenetic Alopecia Among Female Patients in a Specialty Alopecia Clinic
To the Editor:
Female pattern hair loss (FPHL), or androgenetic alopecia (AGA), is the most common form of alopecia worldwide and is characterized by a reduction of hair follicles spent in the anagen phase of growth as well as progressive terminal hair loss.1 It is caused by an excessive response to androgens and leads to the characteristic distribution of hair loss in both sexes. Studies have shown a notable association between AGA and markers of metabolic syndrome such as dyslipidemia, insulin resistance, and obesity in age- and sex-matched controls.2,3 However, research describing the relationship between AGA severity and these markers is scarce.
To understand the relationship between FPHL severity and abnormal cholesterol levels, we performed a retrospective chart review of patients diagnosed with FPHL at a specialty alopecia clinic from June 2022 to December 2022. Patient age and age at onset of FPHL were collected. The severity of FPHL was measured using the Sinclair scale (score range, 1–5) and unidentifiable patient photographs. Laboratory values were collected; abnormal cholesterol was defined by the American Heart Association as having a low-density lipoprotein cholesterol (LDL-C) level of 100 mg/dL or higher.4 Finally, data on medication use were noted to understand patient treatment status (Table).
We identified 54 female patients with FPHL with an average age of 59 years (range, 34–80 years). Thirty-three females (61.11%) had a normal LDL-C level and 21 (38.89%) had an abnormal level. The mean (SD) LDL-C level was 66.02 (15.20) mg/dL (range, 29–92 mg/dL) in the group with normal levels and 138.81 (29.90) mg/dL (range, 100–193 mg/dL) in the group with abnormal levels. Patients with abnormal LDL-C had significantly higher Sinclair scale scores compared to those with normal levels (2.43 vs 1.91; P=.01). There were no significant differences in patient age (58.71 vs 59.70 years; P=.39), age at onset of AGA (47.75 vs 47.65 years; P=.49), history of polycystic ovary syndrome (9.52% vs 6.06%; P=.64), or statin use (38.09% vs 36.36%; P=.89) between patients with abnormal and normal LDL-C levels, respectively. There also were no significant differences in ferritin (96.42 vs 91.54 ng/mL; P=.40), vitamin D (42.35 vs 48.96 ng/mL; P=.09), or hemoglobin A1c levels (5.60 ng/mL vs 5.38 ng/mL; P=.06)—variables that could have confounded this relationship. Triglycerides were within reference range in both groups (121.36 vs 116.16 mg/dL; P=.32), while total cholesterol was mildly elevated in both groups but not significantly different (213.19 vs 201.21 mg/dL; P=.13). Use of hair loss treatments such as topical minoxidil (14.29% vs 21.21%; P=.53), oral low-dose minoxidil (57.14% vs 66.67%; P=.48), oral spironolactone (47.62% vs 57.58%; P=.47), and platelet-rich plasma injections (47.62% vs 27.27%; P=.90) were not significantly different across both groups.
The data suggest a significant (P<.05) association between abnormal LDL-C and hair loss severity in FPHL patients. Our study was limited by its small sample size and lack of causality; however, it coincides with and reiterates the findings established in the literature. The mechanism of the association between hyperlipidemia and AGA is not well understood but is thought to stem from the homology between cholesterol and androgens. Increased cholesterol release from dermal adipocytes and subsequent absorption into hair follicle cell populations may increase hair follicle steroidogenesis, thereby accelerating the anagen-catagen transition and inducing AGA. Alternatively, impaired cholesterol homeostasis may disrupt normal hair follicle cycling by interrupting signaling pathways in follicle proliferation and differentiation.5 Adequate control and monitoring of LDL-C levels may be important, particularly in patients with more severe FPHL.
- Herskovitz I, Tosti A. Female pattern hair loss. Int J Endocrinol Metab. 2013;11:E9860. doi:10.5812/ijem.9860
- El Sayed MH, Abdallah MA, Aly DG, et al. Association of metabolic syndrome with female pattern hair loss in women: a case-control study. Int J Dermatol. 2016;55:1131-1137. doi:10.1111/ijd.13303
- Kim MW, Shin IS, Yoon HS, et al. Lipid profile in patients with androgenetic alopecia: a meta-analysis. J Eur Acad Dermatol Venereol. 2017;31:942-951. doi:10.1111/jdv.14000
- Birtcher KK, Ballantyne CM. Cardiology patient page. measurement of cholesterol: a patient perspective. Circulation. 2004;110:E296-E297. doi:10.1161/01.CIR.0000141564.89465.4E
- Palmer MA, Blakeborough L, Harries M, et al. Cholesterol homeostasis: links to hair follicle biology and hair disorders. Exp Dermatol. 2020;29:299-311. doi:10.1111/exd.13993
To the Editor:
Female pattern hair loss (FPHL), or androgenetic alopecia (AGA), is the most common form of alopecia worldwide and is characterized by a reduction of hair follicles spent in the anagen phase of growth as well as progressive terminal hair loss.1 It is caused by an excessive response to androgens and leads to the characteristic distribution of hair loss in both sexes. Studies have shown a notable association between AGA and markers of metabolic syndrome such as dyslipidemia, insulin resistance, and obesity in age- and sex-matched controls.2,3 However, research describing the relationship between AGA severity and these markers is scarce.
To understand the relationship between FPHL severity and abnormal cholesterol levels, we performed a retrospective chart review of patients diagnosed with FPHL at a specialty alopecia clinic from June 2022 to December 2022. Patient age and age at onset of FPHL were collected. The severity of FPHL was measured using the Sinclair scale (score range, 1–5) and unidentifiable patient photographs. Laboratory values were collected; abnormal cholesterol was defined by the American Heart Association as having a low-density lipoprotein cholesterol (LDL-C) level of 100 mg/dL or higher.4 Finally, data on medication use were noted to understand patient treatment status (Table).
We identified 54 female patients with FPHL with an average age of 59 years (range, 34–80 years). Thirty-three females (61.11%) had a normal LDL-C level and 21 (38.89%) had an abnormal level. The mean (SD) LDL-C level was 66.02 (15.20) mg/dL (range, 29–92 mg/dL) in the group with normal levels and 138.81 (29.90) mg/dL (range, 100–193 mg/dL) in the group with abnormal levels. Patients with abnormal LDL-C had significantly higher Sinclair scale scores compared to those with normal levels (2.43 vs 1.91; P=.01). There were no significant differences in patient age (58.71 vs 59.70 years; P=.39), age at onset of AGA (47.75 vs 47.65 years; P=.49), history of polycystic ovary syndrome (9.52% vs 6.06%; P=.64), or statin use (38.09% vs 36.36%; P=.89) between patients with abnormal and normal LDL-C levels, respectively. There also were no significant differences in ferritin (96.42 vs 91.54 ng/mL; P=.40), vitamin D (42.35 vs 48.96 ng/mL; P=.09), or hemoglobin A1c levels (5.60 ng/mL vs 5.38 ng/mL; P=.06)—variables that could have confounded this relationship. Triglycerides were within reference range in both groups (121.36 vs 116.16 mg/dL; P=.32), while total cholesterol was mildly elevated in both groups but not significantly different (213.19 vs 201.21 mg/dL; P=.13). Use of hair loss treatments such as topical minoxidil (14.29% vs 21.21%; P=.53), oral low-dose minoxidil (57.14% vs 66.67%; P=.48), oral spironolactone (47.62% vs 57.58%; P=.47), and platelet-rich plasma injections (47.62% vs 27.27%; P=.90) were not significantly different across both groups.
The data suggest a significant (P<.05) association between abnormal LDL-C and hair loss severity in FPHL patients. Our study was limited by its small sample size and lack of causality; however, it coincides with and reiterates the findings established in the literature. The mechanism of the association between hyperlipidemia and AGA is not well understood but is thought to stem from the homology between cholesterol and androgens. Increased cholesterol release from dermal adipocytes and subsequent absorption into hair follicle cell populations may increase hair follicle steroidogenesis, thereby accelerating the anagen-catagen transition and inducing AGA. Alternatively, impaired cholesterol homeostasis may disrupt normal hair follicle cycling by interrupting signaling pathways in follicle proliferation and differentiation.5 Adequate control and monitoring of LDL-C levels may be important, particularly in patients with more severe FPHL.
To the Editor:
Female pattern hair loss (FPHL), or androgenetic alopecia (AGA), is the most common form of alopecia worldwide and is characterized by a reduction of hair follicles spent in the anagen phase of growth as well as progressive terminal hair loss.1 It is caused by an excessive response to androgens and leads to the characteristic distribution of hair loss in both sexes. Studies have shown a notable association between AGA and markers of metabolic syndrome such as dyslipidemia, insulin resistance, and obesity in age- and sex-matched controls.2,3 However, research describing the relationship between AGA severity and these markers is scarce.
To understand the relationship between FPHL severity and abnormal cholesterol levels, we performed a retrospective chart review of patients diagnosed with FPHL at a specialty alopecia clinic from June 2022 to December 2022. Patient age and age at onset of FPHL were collected. The severity of FPHL was measured using the Sinclair scale (score range, 1–5) and unidentifiable patient photographs. Laboratory values were collected; abnormal cholesterol was defined by the American Heart Association as having a low-density lipoprotein cholesterol (LDL-C) level of 100 mg/dL or higher.4 Finally, data on medication use were noted to understand patient treatment status (Table).
We identified 54 female patients with FPHL with an average age of 59 years (range, 34–80 years). Thirty-three females (61.11%) had a normal LDL-C level and 21 (38.89%) had an abnormal level. The mean (SD) LDL-C level was 66.02 (15.20) mg/dL (range, 29–92 mg/dL) in the group with normal levels and 138.81 (29.90) mg/dL (range, 100–193 mg/dL) in the group with abnormal levels. Patients with abnormal LDL-C had significantly higher Sinclair scale scores compared to those with normal levels (2.43 vs 1.91; P=.01). There were no significant differences in patient age (58.71 vs 59.70 years; P=.39), age at onset of AGA (47.75 vs 47.65 years; P=.49), history of polycystic ovary syndrome (9.52% vs 6.06%; P=.64), or statin use (38.09% vs 36.36%; P=.89) between patients with abnormal and normal LDL-C levels, respectively. There also were no significant differences in ferritin (96.42 vs 91.54 ng/mL; P=.40), vitamin D (42.35 vs 48.96 ng/mL; P=.09), or hemoglobin A1c levels (5.60 ng/mL vs 5.38 ng/mL; P=.06)—variables that could have confounded this relationship. Triglycerides were within reference range in both groups (121.36 vs 116.16 mg/dL; P=.32), while total cholesterol was mildly elevated in both groups but not significantly different (213.19 vs 201.21 mg/dL; P=.13). Use of hair loss treatments such as topical minoxidil (14.29% vs 21.21%; P=.53), oral low-dose minoxidil (57.14% vs 66.67%; P=.48), oral spironolactone (47.62% vs 57.58%; P=.47), and platelet-rich plasma injections (47.62% vs 27.27%; P=.90) were not significantly different across both groups.
The data suggest a significant (P<.05) association between abnormal LDL-C and hair loss severity in FPHL patients. Our study was limited by its small sample size and lack of causality; however, it coincides with and reiterates the findings established in the literature. The mechanism of the association between hyperlipidemia and AGA is not well understood but is thought to stem from the homology between cholesterol and androgens. Increased cholesterol release from dermal adipocytes and subsequent absorption into hair follicle cell populations may increase hair follicle steroidogenesis, thereby accelerating the anagen-catagen transition and inducing AGA. Alternatively, impaired cholesterol homeostasis may disrupt normal hair follicle cycling by interrupting signaling pathways in follicle proliferation and differentiation.5 Adequate control and monitoring of LDL-C levels may be important, particularly in patients with more severe FPHL.
- Herskovitz I, Tosti A. Female pattern hair loss. Int J Endocrinol Metab. 2013;11:E9860. doi:10.5812/ijem.9860
- El Sayed MH, Abdallah MA, Aly DG, et al. Association of metabolic syndrome with female pattern hair loss in women: a case-control study. Int J Dermatol. 2016;55:1131-1137. doi:10.1111/ijd.13303
- Kim MW, Shin IS, Yoon HS, et al. Lipid profile in patients with androgenetic alopecia: a meta-analysis. J Eur Acad Dermatol Venereol. 2017;31:942-951. doi:10.1111/jdv.14000
- Birtcher KK, Ballantyne CM. Cardiology patient page. measurement of cholesterol: a patient perspective. Circulation. 2004;110:E296-E297. doi:10.1161/01.CIR.0000141564.89465.4E
- Palmer MA, Blakeborough L, Harries M, et al. Cholesterol homeostasis: links to hair follicle biology and hair disorders. Exp Dermatol. 2020;29:299-311. doi:10.1111/exd.13993
- Herskovitz I, Tosti A. Female pattern hair loss. Int J Endocrinol Metab. 2013;11:E9860. doi:10.5812/ijem.9860
- El Sayed MH, Abdallah MA, Aly DG, et al. Association of metabolic syndrome with female pattern hair loss in women: a case-control study. Int J Dermatol. 2016;55:1131-1137. doi:10.1111/ijd.13303
- Kim MW, Shin IS, Yoon HS, et al. Lipid profile in patients with androgenetic alopecia: a meta-analysis. J Eur Acad Dermatol Venereol. 2017;31:942-951. doi:10.1111/jdv.14000
- Birtcher KK, Ballantyne CM. Cardiology patient page. measurement of cholesterol: a patient perspective. Circulation. 2004;110:E296-E297. doi:10.1161/01.CIR.0000141564.89465.4E
- Palmer MA, Blakeborough L, Harries M, et al. Cholesterol homeostasis: links to hair follicle biology and hair disorders. Exp Dermatol. 2020;29:299-311. doi:10.1111/exd.13993
Practice Points
- Associations have been shown between hair loss and markers of bad health such as insulin resistance and high cholesterol. Research has not yet shown the relationship between hair loss severity and these markers, particularly cholesterol.
Acne and Pregnancy: A Clinical Review and Practice Pearls
Acne vulgaris, or acne, is a highly common inflammatory skin disorder affecting up to 85% of the population, and it constitutes the most commonly presenting chief concern in routine dermatology practice.1 Older teenagers and young adults are most often affected by acne.2 Although acne generally is more common in males, adult-onset acne occurs more frequently in women.2,3 Black and Hispanic women are at higher risk for acne compared to those of Asian, White, or Continental Indian descent.4 As such, acne is a common concern in all women of childbearing age.
Concerns for maternal and fetal safety are important therapeutic considerations, especially because hormonal and physiologic changes in pregnancy can lead to onset of inflammatory acne lesions, particularly during the second and third trimesters.5 Female patients younger than 25 years; with a higher body mass index, prior irregular menstruation, or polycystic ovary syndrome; or those experiencing their first pregnancy are thought to be more commonly affected.5-7 In fact, acne affects up to 43% of pregnant women, and lesions typically extend beyond the face to involve the trunk.6,8-10 Importantly, one-third of women with a history of acne experience symptom relapse after disease-free periods, while two-thirds of those with ongoing disease experience symptom deterioration during pregnancy.10 Although acne is not a life-threatening condition, it has a well-documented, detrimental impact on social, emotional, and psychological well-being, namely self-perception, social interactions, quality-of-life scores, depression, and anxiety.11
Therefore, safe and effective treatment of pregnant women is of paramount importance. Because pregnant women are not included in clinical trials, there is a paucity of medication safety data, further augmented by inefficient access to available information. The US Food and Drug Administration (FDA) pregnancy safety categories were updated in 2015, letting go of the traditional A, B, C, D, and X categories.12 The Table reviews the current pregnancy classification system. In this narrative review, we summarize the most recent available data and recommendations on the safety and efficacy of acne treatment during pregnancy.
Topical Treatments for Acne
Benzoyl Peroxide—Benzoyl peroxide commonly is used as first-line therapy alone or in combination with other agents for the treatment of mild to moderate acne.13 It is safe for use during pregnancy.14 Although the medication is systemically absorbed, it undergoes complete metabolism to benzoic acid, a commonly used food additive.15,16 Benzoic acid has low bioavailability, as it gets rapidly metabolized by the kidneys; therefore, benzoyl peroxide is unlikely to reach clinically significant levels in the maternal circulation and consequently the fetal circulation. Additionally, it has a low risk for causing congenital malformations.17
Salicylic Acid—For mild to moderate acne, salicylic acid is a second-line agent that likely is safe for use by pregnant women at low concentrations and over limited body surface areas.14,18,19 There is minimal systemic absorption of the drug.20 Additionally, aspirin, which is broken down in the body into salicylic acid, is used in low doses for the treatment of pre-eclampsia during pregnancy.21
Dapsone—The use of dapsone gel 5% as a second-line agent has shown efficacy for mild to moderate acne.22 The oral formulation, commonly used for malaria and leprosy prophylaxis, has failed to show associated fetal toxicity or congenital anomalies.23,24 It also has been used as a first-line treatment for dermatitis herpetiformis in pregnancy.25 Although the medication likely is safe, it is better to minimize its use during the third trimester to reduce the theoretical risk for hyperbilirubinemia in the neonate.17,26-29
Azelaic Acid—Azelaic acid effectively targets noninflammatory and inflammatory acne and generally is well tolerated, harboring a good safety profile.30 Topical 20% azelaic acid has localized antibacterial and comedolytic effects and is safe for use during pregnancy.31,32
Glycolic Acid—Limited data exist on the safety of glycolic acid during pregnancy. In vitro studies have shown up to 27% systemic absorption depending on pH, concentration, and duration of application.33 Animal reproductive studies involving rats have shown fetal multisystem malformations and developmental abnormalities with oral administration of glycolic acid at doses far exceeding those used in humans.34 Although no human reproductive studies exist, topical glycolic acid is unlikely to reach the developing fetus in notable amounts, and the medication is likely safe for use.17,35
Clindamycin—Topical clindamycin phosphate is an effective and well-tolerated agent for the treatment of mild to moderate acne.36 Its systemic absorption is minimal, and it is considered safe for use during all trimesters of pregnancy.14,17,26,27,35,37
Erythromycin—Topical erythromycin is another commonly prescribed topical antibiotic used to target mild to moderate acne. However, its use recently has been associated with a decrease in efficacy secondary to the rise of antibacterial resistance in the community.38-40 Nevertheless, it remains a safe treatment for use during all trimesters of pregnancy.14,17,26,27,35,37
Topical Retinoids—Vitamin A derivatives (also known as retinoids) are the mainstay for the treatment of mild to moderate acne. Limited data exist regarding pregnancy outcomes after in utero exposure.41 A rare case report suggested topical tretinoin has been associated with fetal otocerebral anomalies.42 For tazarotene, teratogenic effects were seen in animal reproductive studies at doses exceeding maximum recommended human doses.41,43 However, a large meta-analysis failed to find a clear risk for increased congenital malformations, spontaneous abortions, stillbirth, elective termination of pregnancy, low birthweight, or prematurity following first-trimester exposure to topical retinoids.44 As the level of exposure that could lead to teratogenicity in humans is unknown, avoidance of both tretinoin and tazarotene is recommended in pregnant women.41,45 Nevertheless, women inadvertently exposed should be reassured.44
Conversely, adapalene has been associated with 1 case of anophthalmia and agenesis of the optic chiasma in a fetus following exposure until 13 weeks’ gestation.46 However, a large, open-label trial prior to the patient transitioning from adapalene to over-the-counter treatment showed that the drug harbors a large and reassuring margin of safety and no risk for teratogenicity in a maximal usage trial and Pregnancy Safety Review.47 Therefore, adapalene gel 0.1% is a safe and effective medication for the treatment of acne in a nonprescription environment and does not pose harm to the fetus.
Clascoterone—Clascoterone is a novel topical antiandrogenic drug approved for the treatment of hormonal and inflammatory moderate to severe acne.48-51 Human reproductive data are limited to 1 case of pregnancy that occurred during phase 3 trial investigations, and no adverse outcomes were reported.51 Minimal systemic absorption follows topical use.52 Nonetheless, dose-independent malformations were reported in animal reproductive studies.53 As such, it remains better to avoid the use of clascoterone during pregnancy pending further safety data.
Minocycline Foam—Minocycline foam 4% is approved to treat inflammatory lesions of nonnodular moderate to severe acne in patients 9 years and older.54 Systemic absorption is minimal, and the drug has limited bioavailability with minimal systemic accumulation in the patient’s serum.55 Given this information, it is unlikely that topical minocycline will reach notable levels in the fetal serum or harbor teratogenic effects, as seen with the oral formulation.56 However, it may be best to avoid its use during the second and third trimesters given the potential risk for tooth discoloration in the fetus.57,58
Systemic Treatments for Acne
Isotretinoin—Isotretinoin is the most effective treatment for moderate to severe acne with a well-documented potential for long-term clearance.59 Its use during pregnancy is absolutely contraindicated, as the medication is a well-known teratogen. Associated congenital malformations include numerous craniofacial defects, cardiovascular and neurologic malformations, or thymic disorders that are estimated to affect 20% to 35% of infants exposed in utero.60 Furthermore, strict contraception use during treatment is mandated for patients who can become pregnant. It is recommended to wait at least 1 month and 1 menstrual cycle after medication discontinuation before attempting to conceive.17 Pregnancy termination is recommended if conception occurs during treatment with isotretinoin.
Spironolactone—Spironolactone is an androgen-receptor antagonist commonly prescribed off label for mild to severe acne in females.61,62 Spironolactone promotes the feminization of male fetuses and should be avoided in pregnancy.63
Doxycycline/Minocycline—Tetracyclines are the most commonly prescribed oral antibiotics for moderate to severe acne.64 Although highly effective at treating acne, tetracyclines generally should be avoided in pregnancy. First-trimester use of doxycycline is not absolutely contraindicated but should be reserved for severe illness and not employed for the treatment of acne. However, accidental exposure to doxycycline has not been associated with congenital malformations.65 Nevertheless, after the 15th week of gestation, permanent tooth discoloration and bone growth inhibition in the fetus are serious and well-documented risks.14,17 Additional adverse events following in utero exposure include infantile inguinal hernia, hypospadias, and limb hypoplasia.63
Sarecycline—Sarecycline is a novel tetracycline-class antibiotic for the treatment of moderate to severe inflammatory acne. It has a narrower spectrum of activity compared to its counterparts within its class, which translates to an improved safety profile, namely when it comes to gastrointestinal tract microbiome disruption and potentially decreased likelihood of developing bacterial resistance.66 Data on human reproductive studies are limited, but it is advisable to avoid sarecycline in pregnancy, as it may cause adverse developmental effects in the fetus, such as reduced bone growth, in addition to the well-known tetracycline-associated risk for permanent discoloration of the teeth if used during the second and third trimesters.67,68
Erythromycin—Oral erythromycin targets moderate to severe inflammatory acne and is considered safe for use during pregnancy.69,70 There has been 1 study reporting an increased risk for atrial and ventricular septal defects (1.8%) and pyloric stenosis (0.2%), but these risks are still uncertain, and erythromycin is considered compatible with pregnancy.71 However, erythromycin estolate formulations should be avoided given the associated 10% to 15% risk for reversible cholestatic liver injury.72 Erythromycin base or erythromycin ethylsuccinate formulations should be favored.
Systemic Steroids—Prednisone is indicated for severe acne with scarring and should only be used during pregnancy after clearance from the patient’s obstetrician. Doses of 0.5 mg/kg or less should be prescribed in combination with systemic antibiotics as well as agents for bone and gastrointestinal tract prophylaxis.29
Zinc—The exact mechanism by which zinc exerts its effects to improve acne remains largely obscure. It has been found effective against inflammatory lesions of mild to moderate acne.73 Generally recommended dosages range from 30 to 200 mg/d but may be associated with gastrointestinal tract disturbances. Dosages of 75 mg/d have shown no harm to the fetus.74 When taking this supplement, patients should not exceed the recommended doses given the risk for hypocupremia associated with high-dose zinc supplementation.
Light-Based Therapies
Phototherapy—Narrowband UVB phototherapy is effective for the treatment of mild to moderate acne.75 It has been proven to be a safe treatment option during pregnancy, but its use has been associated with decreased folic acid levels.76-79 Therefore, in addition to attaining baseline folic acid serum levels, supplementation with folic acid prior to treatment, as per routine prenatal guidelines, should be sought.80
AviClear—The AviClear (Cutera) laser is the first device cleared by the FDA for mild to severe acne in March 2022.81 The FDA clearance for the Accure (Accure Acne Inc) laser, also targeting mild to severe acne, followed soon after (November 2022). Both lasers harbor a wavelength of 1726 nm and target sebaceous glands with electrothermolysis.82,83 Further research and long-term safety data are required before using them in pregnancy.
Other Therapies
Cosmetic Peels—Glycolic acid peels induce epidermolysis and desquamation.84 Although data on use during pregnancy are limited, these peels have limited dermal penetration and are considered safe for use in pregnancy.33,85,86 Similarly, keratolytic lactic acid peels harbor limited dermal penetration and can be safely used in pregnant women.87-89 Salicylic acid peels also work through epidermolysis and desquamation84; however, they tend to penetrate deeper into the skin, reaching down to the basal layer, if large areas are treated or when applied under occlusion.86,90 Although their use is not contraindicated in pregnancy, they should be limited to small areas of coverage.91
Intralesional Triamcinolone—Acne cysts and inflammatory papules can be treated with intralesional triamcinolone injections to relieve acute symptoms such as pain.92 Low doses at concentrations of 2.5 mg/mL are considered compatible with pregnancy when indicated.29
Approaching the Patient Clinical Encounter
In patients seeking treatment prior to conception, a few recommendations can be made to minimize the risk for acne recurrence or flares during pregnancy. For instance, because data show an association between increased acne severity in those with a higher body mass index and in pregnancy, weight loss may be recommended prior to pregnancy to help mitigate symptoms after conception.7 The Figure summarizes our recommendations for approaching and treating acne in pregnancy.
In all patients, grading the severity of the patient’s acne as mild, moderate, or severe is the first step. The presence of scarring is an additional consideration during the physical examination and should be documented. A careful discussion of treatment expectations and prognosis should be the focus before treatment initiation. Meticulous documentation of the physical examination and discussion with the patient should be prioritized.
To minimize toxicity and risks to the developing fetus, monotherapy is favored. Topical therapy should be considered first line. Safe regimens include mild nonabrasive washes, such as those containing benzoyl peroxide or glycolic acid, or topical azelaic acid or clindamycin phosphate for mild to moderate acne. More severe cases warrant the consideration of systemic medications as second line, as more severe acne is better treated with oral antibiotics such as the macrolides erythromycin or clindamycin or systemic corticosteroids when concern exists for severe scarring. The additional use of physical sunscreen also is recommended.
An important topic to address during the clinical encounter is cautious intake of oral supplements for acne during pregnancy, as they may contain harmful and teratogenic ingredients. A recent search focusing on acne supplements available online between March and May 2020 uncovered 49 different supplements, 26 (53%) of which contained vitamin A.93 Importantly, 3 (6%) of these 49 supplements were likely teratogenic, 4 (8%) contained vitamin A doses exceeding the recommended daily nutritional intake level, and 15 (31%) harbored an unknown teratogenic risk. Furthermore, among the 6 (12%) supplements with vitamin A levels exceeding 10,000 IU, 2 lacked any mention of pregnancy warning, including the supplement with the highest vitamin A dose found in this study.93 Because dietary supplements are not subject to the same stringent regulations by the FDA as drugs, inadvertent use by unaware patients ought to be prevented by careful counseling and education.
Finally, patients should be counseled to seek care following delivery for potentially updated medication management of acne, especially if they are breastfeeding. Co-management with a pediatrician may be indicated during lactation, particularly when newborns are born preterm or with other health conditions that may warrant additional caution with the use of certain agents.
- Bhate K, Williams H. Epidemiology of acne vulgaris. Br J Dermatol. 2013;168:474-485.
- Heng AHS, Chew FT. Systematic review of the epidemiology of acne vulgaris. Sci Rep. 2020;10:5754.
- Fisk WA, Lev-Tov HA, Sivamani RK. Epidemiology and management of acne in adult women. Curr Dermatol Rep. 2014;3:29-39.
- Perkins A, Cheng C, Hillebrand G, et al. Comparison of the epidemiology of acne vulgaris among Caucasian, Asian, Continental Indian and African American women. J Eur Acad Dermatol Venereol. 2011;25:1054-1060.
- Yang CC, Huang YT, Yu CH, et al. Inflammatory facial acne during uncomplicated pregnancy and post‐partum in adult women: a preliminary hospital‐based prospective observational study of 35 cases from Taiwan. J Eur Acad Dermatol Venereol. 2016;30:1787-1789.
- Dréno B, Blouin E, Moyse D, et al. Acne in pregnant women: a French survey. Acta Derm Venereol. 2014;94:82-83.
- Kutlu Ö, Karadag˘ AS, Ünal E, et al. Acne in pregnancy: a prospective multicenter, cross‐sectional study of 295 patients in Turkey. Int J Dermatol. 2020;59:1098-1105.
- Hoefel IDR, Weber MB, Manzoni APD, et al. Striae gravidarum, acne, facial spots, and hair disorders: risk factors in a study with 1284 puerperal patients. J Pregnancy. 2020;2020:8036109.
- Ayanlowo OO, Otrofanowei E, Shorunmu TO, et al. Pregnancy dermatoses: a study of patients attending the antenatal clinic at two tertiary care centers in south west Nigeria. PAMJ Clin Med. 2020;3.
- Bechstein S, Ochsendorf F. Acne and rosacea in pregnancy. Hautarzt. 2017;68:111-119.
- Habeshian KA, Cohen BA. Current issues in the treatment of acne vulgaris. Pediatrics. 2020;145(suppl 2):S225-S230.
- Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling (21 CFR 201). Fed Regist. 2014;79:72064-72103.
- Sagransky M, Yentzer BA, Feldman SR. Benzoyl peroxide: a review of its current use in the treatment of acne vulgaris. Expert Opin Pharmacother. 2009;10:2555-2562.
- Murase JE, Heller MM, Butler DC. Safety of dermatologic medications in pregnancy and lactation: part I. Pregnancy. J Am Acad Dermatol. 2014;70:401.e1-401.e14; quiz 415.
- Wolverton SE. Systemic corticosteroids. Comprehensive Dermatol Drug Ther. 2012;3:143-168.
- Kirtschig G, Schaefer C. Dermatological medications and local therapeutics. In: Schaefer C, Peters P, Miller RK, eds. Drugs During Pregnancy and Lactation. 3rd edition. Elsevier; 2015:467-492.
- Pugashetti R, Shinkai K. Treatment of acne vulgaris in pregnant patients. Dermatol Ther. 2013;26:302-311.
- Touitou E, Godin B, Shumilov M, et al. Efficacy and tolerability of clindamycin phosphate and salicylic acid gel in the treatment of mild to moderate acne vulgaris. J Eur Acad Dermatol Venereol. 2008;22:629-631.
- Schaefer C, Peters PW, Miller RK, eds. Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment. 2nd ed. Academic Press; 2014.
- Birmingham B, Greene D, Rhodes C. Systemic absorption of topical salicylic acid. Int J Dermatol. 1979;18:228-231.
- Trivedi NA. A meta-analysis of low-dose aspirin for prevention of preeclampsia. J Postgrad Med. 2011;57:91-95.
- Lucky AW, Maloney JM, Roberts J, et al. Dapsone gel 5% for the treatment of acne vulgaris: safety and efficacy of long-term (1 year) treatment. J Drugs Dermatol. 2007;6:981-987.
- Nosten F, McGready R, d’Alessandro U, et al. Antimalarial drugs in pregnancy: a review. Curr Drug Saf. 2006;1:1-15.
- Brabin BJ, Eggelte TA, Parise M, et al. Dapsone therapy for malaria during pregnancy: maternal and fetal outcomes. Drug Saf. 2004;27:633-648.
- Tuffanelli DL. Successful pregnancy in a patient with dermatitis herpetiformis treated with low-dose dapsone. Arch Dermatol. 1982;118:876.
- Meredith FM, Ormerod AD. The management of acne vulgaris in pregnancy. Am J Clin Dermatol. 2013;14:351-358.
- Kong Y, Tey H. Treatment of acne vulgaris during pregnancy and lactation. Drugs. 2013;73:779-787.
- Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006;24:167-197.
- Ly S, Kamal K, Manjaly P, et al. Treatment of acne vulgaris during pregnancy and lactation: a narrative review. Dermatol Ther. 2023;13:115-130.
- Webster G. Combination azelaic acid therapy for acne vulgaris. J Am Acad Dermatol. 2000;43:S47-S50.
- Archer CB, Cohen SN, Baron SE. Guidance on the diagnosis and clinical management of acne. Clin Exp Dermatol. 2012;37(suppl 1):1-6.
- Graupe K, Cunliffe W, Gollnick H, et al. Efficacy and safety of topical azelaic acid (20 percent cream): an overview of results from European clinical trials and experimental reports. Cutis. 1996;57(1 suppl):20-35.
- Bozzo P, Chua-Gocheco A, Einarson A. Safety of skin care products during pregnancy. Can Fam Physician. 2011;57:665-667.
- Munley SM, Kennedy GL, Hurtt ME. Developmental toxicity study of glycolic acid in rats. Drug Chem Toxicol. 1999;22:569-582.
- Chien AL, Qi J, Rainer B, et al. Treatment of acne in pregnancy. J Am Board Fam Med. 2016;29:254-262.
- Stuart B, Maund E, Wilcox C, et al. Topical preparations for the treatment of mild‐to‐moderate acne vulgaris: systematic review and network meta‐analysis. Br J Dermatol. 2021;185:512-525.
- van Hoogdalem EJ, Baven TL, Spiegel‐Melsen I, et al. Transdermal absorption of clindamycin and tretinoin from topically applied anti‐acne formulations in man. Biopharm Drug Dispos. 1998;19:563-569.
- Austin BA, Fleischer AB Jr. The extinction of topical erythromycin therapy for acne vulgaris and concern for the future of topical clindamycin. J Dermatolog Treat. 2017;28:145-148.
- Eady EA, Cove J, Holland K, et al. Erythromycin resistant propionibacteria in antibiotic treated acne patients: association with therapeutic failure. Br J. Dermatol. 1989;121:51-57.
- Alkhawaja E, Hammadi S, Abdelmalek M, et al. Antibiotic resistant Cutibacterium acnes among acne patients in Jordan: a cross sectional study. BMC Dermatol. 2020;20:1-9.
- Han G, Wu JJ, Del Rosso JQ. Use of topical tazarotene for the treatment of acne vulgaris in pregnancy: a literature review. J Clin Aesthet Dermatol. 2020;13:E59-E65.
- Selcen D, Seidman S, Nigro MA. Otocerebral anomalies associated with topical tretinoin use. Brain Dev. 2000;22:218-220.
- Moretz D. Drug Class Update with New Drug Evaluations: Topical Products for Inflammatory Skin Conditions. Oregon State University Drug Use & Research Management Program; December 2022. Accessed January 8, 2024. https://www.orpdl.org/durm/meetings/meetingdocs/2022_12_01/archives/2022_12_01_Inflammatory_Skin_Dz_ClassUpdate.pdf
- Kaplan YC, Ozsarfati J, Etwel F, et al. Pregnancy outcomes following first‐trimester exposure to topical retinoids: a systematic review and meta‐analysis. Br J Dermatol. 2015;173:1132-1141.
- Menter A. Pharmacokinetics and safety of tazarotene. J Am Acad Dermatol. 2000;43(2, pt 3):S31-S35.
- Autret E, Berjot M, Jonville-Béra A-P, et al. Anophthalmia and agenesis of optic chiasma associated with adapalene gel in early pregnancy. Lancet. 1997;350:339.
- Weiss J, Mallavalli S, Meckfessel M, et al. Safe use of adapalene 0.1% gel in a non-prescription environment. J Drugs Dermatol. 2021;20:1330-1335.
- Alessandro Mazzetti M. A phase 2b, randomized, double-blind vehicle controlled, dose escalation study evaluating clascoterone 0.1%, 0.5%, and 1% topical cream in subjects with facial acne. J Drugs Dermatol. 2019;18:570-575.
- Eichenfield L, Hebert A, Gold LS, et al. Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris. J Am Acad Dermatol. 2020;83:477-485.
- Trifu V, Tiplica GS, Naumescu E, et al. Cortexolone 17α‐propionate 1% cream, a new potent antiandrogen for topical treatment of acne vulgaris. a pilot randomized, double‐blind comparative study vs. placebo and tretinoin 0.05% cream. Br J Dermatol. 2011;165:177-183.
- Hebert A, Thiboutot D, Gold LS, et al. Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials. JAMA Dermatol. 2020;156:621-630.
- Alkhodaidi ST, Al Hawsawi KA, Alkhudaidi IT, et al. Efficacy and safety of topical clascoterone cream for treatment of acne vulgaris: a systematic review and meta‐analysis of randomized placebo‐controlled trials. Dermatol Ther. 2021;34:e14609.
- Clasoterone. Package insert. Cassiopea Inc; 2020.
- Paik J. Topical minocycline foam 4%: a review in acne vulgaris. Am J Clin Dermatol. 2020;21:449-456.
- Jones TM, Ellman H. Pharmacokinetic comparison of once-daily topical minocycline foam 4% vs oral minocycline for moderate-to-severe acne. J Drugs Dermatol. 2017;16:1022-1028.
- Minocycline hydrochloride extended-release tablets. Package insert. JG Pharma; July 2020. Accessed January 8, 2024. https://www.jgpharmainc.com/assets/pdf/minocycline-hydrochloride.pdf
- Dinnendahl V, Fricke U (eds). Arzneistoff-Profile: Basisinformation über arzneiliche Wirkstoffe. Govi Pharmazeutischer Verlag; 2010.
- Martins AM, Marto JM, Johnson JL, et al. A review of systemic minocycline side effects and topical minocycline as a safer alternative for treating acne and rosacea. Antibiotics. 2021;10:757.
- Landis MN. Optimizing isotretinoin treatment of acne: update on current recommendations for monitoring, dosing, safety, adverse effects, compliance, and outcomes. Am J Clin Dermatol. 2020;21:411-419.
- Draghici C-C, Miulescu R-G, Petca R-C, et al. Teratogenic effect of isotretinoin in both fertile females and males. Exp Ther Med. 2021;21:1-5.
- Barker RA, Wilcox C, Layton AM. Oral spironolactone for acne vulgaris in adult females: an update of the literature. Am J Clin Dermatol. 2020;21:303-305.
- Han JJ, Faletsky A, Barbieri JS, et al. New acne therapies and updates on use of spironolactone and isotretinoin: a narrative review. Dermatol Ther (Heidelb). 2021;11:79-91.
- Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Lippincott Williams & Wilkins; 2012.
- Patel DJ, Bhatia N. Oral antibiotics for acne. Am J Clin Dermatol. 2021;22:193-204.
- Jick H, Holmes LB, Hunter JR, et al. First-trimester drug use and congenital disorders. JAMA. 1981;246:343-346.
- Valente Duarte de Sousa IC. An overview of sarecycline for the treatment of moderate-to-severe acne vulgaris. Exp Opin Pharmacother. 2021;22:145-154.
- Hussar DA, Chahine EB. Omadacycline tosylate, sarecycline hydrochloride, rifamycin sodium, and moxidectin. J Am Pharm Assoc. 2019;59:756-760.
- Haidari W, Bruinsma R, Cardenas-de la Garza JA, et al. Sarecycline review. Ann Pharmacother. 2020;54:164-170.
- Feldman S, Careccia RE, Barham KL, et al. Diagnosis and treatment of acne. Am Fam Physician. 2004;69:2123-2130.
- Gammon WR, Meyer C, Lantis S, et al. Comparative efficacy of oral erythromycin versus oral tetracycline in the treatment of acne vulgaris: a double-blind study. J Am Acad Dermatol. 1986;14:183-186.
- Källén BA, Olausson PO, Danielsson BR. Is erythromycin therapy teratogenic in humans? Reprod Toxicol. 2005;20:209-214.
- McCormack WM, George H, Donner A, et al. Hepatotoxicity of erythromycin estolate during pregnancy. Antimicrob Agents Chemother. 1977;12:630-635.
- Cervantes J, Eber AE, Perper M, et al. The role of zinc in the treatment of acne: a review of the literature. Dermatolog Ther. 2018;31:e12576.
- Dréno B, Blouin E. Acne, pregnant women and zinc salts: a literature review [in French]. Ann Dermatol Venereol. 2008;135:27-33.
- Eid MM, Saleh MS, Allam NM, et al. Narrow band ultraviolet B versus red light-emitting diodes in the treatment of facial acne vulgaris: a randomized controlled trial. Photobiomodul Photomed Laser Surg. 2021;39:418-424.
- Zeichner JA. Narrowband UV-B phototherapy for the treatment of acne vulgaris during pregnancy. Arch Dermatol. 2011;147:537-539.
- El-Saie LT, Rabie AR, Kamel MI, et al. Effect of narrowband ultraviolet B phototherapy on serum folic acid levels in patients with psoriasis. Lasers Med Sci. 2011;26:481-485.
- Park KK, Murase JE. Narrowband UV-B phototherapy during pregnancy and folic acid depletion. Arch Dermatol. 2012;148:132-133.
- Jablonski NG. A possible link between neural tube defects and ultraviolet light exposure. Med Hypotheses. 1999;52:581-582.
- Zhang M, Goyert G, Lim HW. Folate and phototherapy: what should we inform our patients? J Am Acad Dermatol. 2017;77:958-964.
- AviClear. Cutera website. Accessed January 8, 2024. https://www.cutera.com/solutions/aviclear/
- Wu X, Yang Y, Wang Y, et al. Treatment of refractory acne using selective sebaceous gland electro-thermolysis combined with non-thermal plasma. J Cosmet Laser Ther. 2021;23:188-194.
- Ahn GR, Kim JM, Park SJ, et al. Selective sebaceous gland electrothermolysis using a single microneedle radiofrequency device for acne patients: a prospective randomized controlled study. Lasers Surg Med. 2020;52:396-401.
- Fabbrocini G, De Padova MP, Tosti A. Chemical peels: what’s new and what isn’t new but still works well. Facial Plast Surg. 2009;25:329-336.
- Andersen FA. Final report on the safety assessment of glycolic acid, ammonium, calcium, potassium, and sodium glycolates, methyl, ethyl, propyl, and butyl glycolates, and lactic acid, ammonium, calcium, potassium, sodium, and TEA-lactates, methyl, ethyl, isopropyl, and butyl lactates, and lauryl, myristyl, and cetyl lactates. Int J Toxicol. 1998;17(1_suppl):1-241.
- Lee KC, Korgavkar K, Dufresne RG Jr, et al. Safety of cosmetic dermatologic procedures during pregnancy. Dermatol Surg. 2013;39:1573-1586.
- James AH, Brancazio LR, Price T. Aspirin and reproductive outcomes. Obstet Gynecol Surv. 2008;63:49-57.
- Zhou W-S, Xu L, Xie S-H, et al. Decreased birth weight in relation to maternal urinary trichloroacetic acid levels. Sci Total Environ. 2012;416:105-110.
- Schwartz DB, Greenberg MD, Daoud Y, et al. Genital condylomas in pregnancy: use of trichloroacetic acid and laser therapy. Am J Obstet Gynecol. 1988;158:1407-1416.
- Starkman SJ, Mangat DS. Chemical peel (deep, medium, light). Facial Plast Surg Clin North Am. 2020;28:45-57.
- Trivedi M, Kroumpouzos G, Murase J. A review of the safety of cosmetic procedures during pregnancy and lactation. Int J Womens Dermatol. 2017;3:6-10.
- Gallagher T, Taliercio M, Nia JK, et al. Dermatologist use of intralesional triamcinolone in the treatment of acne. J Clin Aesthet Dermatol. 2020;13:41-43.
- Zamil DH, Burns EK, Perez-Sanchez A, et al. Risk of birth defects from vitamin A “acne supplements” sold online. Dermatol Pract Concept. 2021;11:e2021075.
Acne vulgaris, or acne, is a highly common inflammatory skin disorder affecting up to 85% of the population, and it constitutes the most commonly presenting chief concern in routine dermatology practice.1 Older teenagers and young adults are most often affected by acne.2 Although acne generally is more common in males, adult-onset acne occurs more frequently in women.2,3 Black and Hispanic women are at higher risk for acne compared to those of Asian, White, or Continental Indian descent.4 As such, acne is a common concern in all women of childbearing age.
Concerns for maternal and fetal safety are important therapeutic considerations, especially because hormonal and physiologic changes in pregnancy can lead to onset of inflammatory acne lesions, particularly during the second and third trimesters.5 Female patients younger than 25 years; with a higher body mass index, prior irregular menstruation, or polycystic ovary syndrome; or those experiencing their first pregnancy are thought to be more commonly affected.5-7 In fact, acne affects up to 43% of pregnant women, and lesions typically extend beyond the face to involve the trunk.6,8-10 Importantly, one-third of women with a history of acne experience symptom relapse after disease-free periods, while two-thirds of those with ongoing disease experience symptom deterioration during pregnancy.10 Although acne is not a life-threatening condition, it has a well-documented, detrimental impact on social, emotional, and psychological well-being, namely self-perception, social interactions, quality-of-life scores, depression, and anxiety.11
Therefore, safe and effective treatment of pregnant women is of paramount importance. Because pregnant women are not included in clinical trials, there is a paucity of medication safety data, further augmented by inefficient access to available information. The US Food and Drug Administration (FDA) pregnancy safety categories were updated in 2015, letting go of the traditional A, B, C, D, and X categories.12 The Table reviews the current pregnancy classification system. In this narrative review, we summarize the most recent available data and recommendations on the safety and efficacy of acne treatment during pregnancy.
Topical Treatments for Acne
Benzoyl Peroxide—Benzoyl peroxide commonly is used as first-line therapy alone or in combination with other agents for the treatment of mild to moderate acne.13 It is safe for use during pregnancy.14 Although the medication is systemically absorbed, it undergoes complete metabolism to benzoic acid, a commonly used food additive.15,16 Benzoic acid has low bioavailability, as it gets rapidly metabolized by the kidneys; therefore, benzoyl peroxide is unlikely to reach clinically significant levels in the maternal circulation and consequently the fetal circulation. Additionally, it has a low risk for causing congenital malformations.17
Salicylic Acid—For mild to moderate acne, salicylic acid is a second-line agent that likely is safe for use by pregnant women at low concentrations and over limited body surface areas.14,18,19 There is minimal systemic absorption of the drug.20 Additionally, aspirin, which is broken down in the body into salicylic acid, is used in low doses for the treatment of pre-eclampsia during pregnancy.21
Dapsone—The use of dapsone gel 5% as a second-line agent has shown efficacy for mild to moderate acne.22 The oral formulation, commonly used for malaria and leprosy prophylaxis, has failed to show associated fetal toxicity or congenital anomalies.23,24 It also has been used as a first-line treatment for dermatitis herpetiformis in pregnancy.25 Although the medication likely is safe, it is better to minimize its use during the third trimester to reduce the theoretical risk for hyperbilirubinemia in the neonate.17,26-29
Azelaic Acid—Azelaic acid effectively targets noninflammatory and inflammatory acne and generally is well tolerated, harboring a good safety profile.30 Topical 20% azelaic acid has localized antibacterial and comedolytic effects and is safe for use during pregnancy.31,32
Glycolic Acid—Limited data exist on the safety of glycolic acid during pregnancy. In vitro studies have shown up to 27% systemic absorption depending on pH, concentration, and duration of application.33 Animal reproductive studies involving rats have shown fetal multisystem malformations and developmental abnormalities with oral administration of glycolic acid at doses far exceeding those used in humans.34 Although no human reproductive studies exist, topical glycolic acid is unlikely to reach the developing fetus in notable amounts, and the medication is likely safe for use.17,35
Clindamycin—Topical clindamycin phosphate is an effective and well-tolerated agent for the treatment of mild to moderate acne.36 Its systemic absorption is minimal, and it is considered safe for use during all trimesters of pregnancy.14,17,26,27,35,37
Erythromycin—Topical erythromycin is another commonly prescribed topical antibiotic used to target mild to moderate acne. However, its use recently has been associated with a decrease in efficacy secondary to the rise of antibacterial resistance in the community.38-40 Nevertheless, it remains a safe treatment for use during all trimesters of pregnancy.14,17,26,27,35,37
Topical Retinoids—Vitamin A derivatives (also known as retinoids) are the mainstay for the treatment of mild to moderate acne. Limited data exist regarding pregnancy outcomes after in utero exposure.41 A rare case report suggested topical tretinoin has been associated with fetal otocerebral anomalies.42 For tazarotene, teratogenic effects were seen in animal reproductive studies at doses exceeding maximum recommended human doses.41,43 However, a large meta-analysis failed to find a clear risk for increased congenital malformations, spontaneous abortions, stillbirth, elective termination of pregnancy, low birthweight, or prematurity following first-trimester exposure to topical retinoids.44 As the level of exposure that could lead to teratogenicity in humans is unknown, avoidance of both tretinoin and tazarotene is recommended in pregnant women.41,45 Nevertheless, women inadvertently exposed should be reassured.44
Conversely, adapalene has been associated with 1 case of anophthalmia and agenesis of the optic chiasma in a fetus following exposure until 13 weeks’ gestation.46 However, a large, open-label trial prior to the patient transitioning from adapalene to over-the-counter treatment showed that the drug harbors a large and reassuring margin of safety and no risk for teratogenicity in a maximal usage trial and Pregnancy Safety Review.47 Therefore, adapalene gel 0.1% is a safe and effective medication for the treatment of acne in a nonprescription environment and does not pose harm to the fetus.
Clascoterone—Clascoterone is a novel topical antiandrogenic drug approved for the treatment of hormonal and inflammatory moderate to severe acne.48-51 Human reproductive data are limited to 1 case of pregnancy that occurred during phase 3 trial investigations, and no adverse outcomes were reported.51 Minimal systemic absorption follows topical use.52 Nonetheless, dose-independent malformations were reported in animal reproductive studies.53 As such, it remains better to avoid the use of clascoterone during pregnancy pending further safety data.
Minocycline Foam—Minocycline foam 4% is approved to treat inflammatory lesions of nonnodular moderate to severe acne in patients 9 years and older.54 Systemic absorption is minimal, and the drug has limited bioavailability with minimal systemic accumulation in the patient’s serum.55 Given this information, it is unlikely that topical minocycline will reach notable levels in the fetal serum or harbor teratogenic effects, as seen with the oral formulation.56 However, it may be best to avoid its use during the second and third trimesters given the potential risk for tooth discoloration in the fetus.57,58
Systemic Treatments for Acne
Isotretinoin—Isotretinoin is the most effective treatment for moderate to severe acne with a well-documented potential for long-term clearance.59 Its use during pregnancy is absolutely contraindicated, as the medication is a well-known teratogen. Associated congenital malformations include numerous craniofacial defects, cardiovascular and neurologic malformations, or thymic disorders that are estimated to affect 20% to 35% of infants exposed in utero.60 Furthermore, strict contraception use during treatment is mandated for patients who can become pregnant. It is recommended to wait at least 1 month and 1 menstrual cycle after medication discontinuation before attempting to conceive.17 Pregnancy termination is recommended if conception occurs during treatment with isotretinoin.
Spironolactone—Spironolactone is an androgen-receptor antagonist commonly prescribed off label for mild to severe acne in females.61,62 Spironolactone promotes the feminization of male fetuses and should be avoided in pregnancy.63
Doxycycline/Minocycline—Tetracyclines are the most commonly prescribed oral antibiotics for moderate to severe acne.64 Although highly effective at treating acne, tetracyclines generally should be avoided in pregnancy. First-trimester use of doxycycline is not absolutely contraindicated but should be reserved for severe illness and not employed for the treatment of acne. However, accidental exposure to doxycycline has not been associated with congenital malformations.65 Nevertheless, after the 15th week of gestation, permanent tooth discoloration and bone growth inhibition in the fetus are serious and well-documented risks.14,17 Additional adverse events following in utero exposure include infantile inguinal hernia, hypospadias, and limb hypoplasia.63
Sarecycline—Sarecycline is a novel tetracycline-class antibiotic for the treatment of moderate to severe inflammatory acne. It has a narrower spectrum of activity compared to its counterparts within its class, which translates to an improved safety profile, namely when it comes to gastrointestinal tract microbiome disruption and potentially decreased likelihood of developing bacterial resistance.66 Data on human reproductive studies are limited, but it is advisable to avoid sarecycline in pregnancy, as it may cause adverse developmental effects in the fetus, such as reduced bone growth, in addition to the well-known tetracycline-associated risk for permanent discoloration of the teeth if used during the second and third trimesters.67,68
Erythromycin—Oral erythromycin targets moderate to severe inflammatory acne and is considered safe for use during pregnancy.69,70 There has been 1 study reporting an increased risk for atrial and ventricular septal defects (1.8%) and pyloric stenosis (0.2%), but these risks are still uncertain, and erythromycin is considered compatible with pregnancy.71 However, erythromycin estolate formulations should be avoided given the associated 10% to 15% risk for reversible cholestatic liver injury.72 Erythromycin base or erythromycin ethylsuccinate formulations should be favored.
Systemic Steroids—Prednisone is indicated for severe acne with scarring and should only be used during pregnancy after clearance from the patient’s obstetrician. Doses of 0.5 mg/kg or less should be prescribed in combination with systemic antibiotics as well as agents for bone and gastrointestinal tract prophylaxis.29
Zinc—The exact mechanism by which zinc exerts its effects to improve acne remains largely obscure. It has been found effective against inflammatory lesions of mild to moderate acne.73 Generally recommended dosages range from 30 to 200 mg/d but may be associated with gastrointestinal tract disturbances. Dosages of 75 mg/d have shown no harm to the fetus.74 When taking this supplement, patients should not exceed the recommended doses given the risk for hypocupremia associated with high-dose zinc supplementation.
Light-Based Therapies
Phototherapy—Narrowband UVB phototherapy is effective for the treatment of mild to moderate acne.75 It has been proven to be a safe treatment option during pregnancy, but its use has been associated with decreased folic acid levels.76-79 Therefore, in addition to attaining baseline folic acid serum levels, supplementation with folic acid prior to treatment, as per routine prenatal guidelines, should be sought.80
AviClear—The AviClear (Cutera) laser is the first device cleared by the FDA for mild to severe acne in March 2022.81 The FDA clearance for the Accure (Accure Acne Inc) laser, also targeting mild to severe acne, followed soon after (November 2022). Both lasers harbor a wavelength of 1726 nm and target sebaceous glands with electrothermolysis.82,83 Further research and long-term safety data are required before using them in pregnancy.
Other Therapies
Cosmetic Peels—Glycolic acid peels induce epidermolysis and desquamation.84 Although data on use during pregnancy are limited, these peels have limited dermal penetration and are considered safe for use in pregnancy.33,85,86 Similarly, keratolytic lactic acid peels harbor limited dermal penetration and can be safely used in pregnant women.87-89 Salicylic acid peels also work through epidermolysis and desquamation84; however, they tend to penetrate deeper into the skin, reaching down to the basal layer, if large areas are treated or when applied under occlusion.86,90 Although their use is not contraindicated in pregnancy, they should be limited to small areas of coverage.91
Intralesional Triamcinolone—Acne cysts and inflammatory papules can be treated with intralesional triamcinolone injections to relieve acute symptoms such as pain.92 Low doses at concentrations of 2.5 mg/mL are considered compatible with pregnancy when indicated.29
Approaching the Patient Clinical Encounter
In patients seeking treatment prior to conception, a few recommendations can be made to minimize the risk for acne recurrence or flares during pregnancy. For instance, because data show an association between increased acne severity in those with a higher body mass index and in pregnancy, weight loss may be recommended prior to pregnancy to help mitigate symptoms after conception.7 The Figure summarizes our recommendations for approaching and treating acne in pregnancy.
In all patients, grading the severity of the patient’s acne as mild, moderate, or severe is the first step. The presence of scarring is an additional consideration during the physical examination and should be documented. A careful discussion of treatment expectations and prognosis should be the focus before treatment initiation. Meticulous documentation of the physical examination and discussion with the patient should be prioritized.
To minimize toxicity and risks to the developing fetus, monotherapy is favored. Topical therapy should be considered first line. Safe regimens include mild nonabrasive washes, such as those containing benzoyl peroxide or glycolic acid, or topical azelaic acid or clindamycin phosphate for mild to moderate acne. More severe cases warrant the consideration of systemic medications as second line, as more severe acne is better treated with oral antibiotics such as the macrolides erythromycin or clindamycin or systemic corticosteroids when concern exists for severe scarring. The additional use of physical sunscreen also is recommended.
An important topic to address during the clinical encounter is cautious intake of oral supplements for acne during pregnancy, as they may contain harmful and teratogenic ingredients. A recent search focusing on acne supplements available online between March and May 2020 uncovered 49 different supplements, 26 (53%) of which contained vitamin A.93 Importantly, 3 (6%) of these 49 supplements were likely teratogenic, 4 (8%) contained vitamin A doses exceeding the recommended daily nutritional intake level, and 15 (31%) harbored an unknown teratogenic risk. Furthermore, among the 6 (12%) supplements with vitamin A levels exceeding 10,000 IU, 2 lacked any mention of pregnancy warning, including the supplement with the highest vitamin A dose found in this study.93 Because dietary supplements are not subject to the same stringent regulations by the FDA as drugs, inadvertent use by unaware patients ought to be prevented by careful counseling and education.
Finally, patients should be counseled to seek care following delivery for potentially updated medication management of acne, especially if they are breastfeeding. Co-management with a pediatrician may be indicated during lactation, particularly when newborns are born preterm or with other health conditions that may warrant additional caution with the use of certain agents.
Acne vulgaris, or acne, is a highly common inflammatory skin disorder affecting up to 85% of the population, and it constitutes the most commonly presenting chief concern in routine dermatology practice.1 Older teenagers and young adults are most often affected by acne.2 Although acne generally is more common in males, adult-onset acne occurs more frequently in women.2,3 Black and Hispanic women are at higher risk for acne compared to those of Asian, White, or Continental Indian descent.4 As such, acne is a common concern in all women of childbearing age.
Concerns for maternal and fetal safety are important therapeutic considerations, especially because hormonal and physiologic changes in pregnancy can lead to onset of inflammatory acne lesions, particularly during the second and third trimesters.5 Female patients younger than 25 years; with a higher body mass index, prior irregular menstruation, or polycystic ovary syndrome; or those experiencing their first pregnancy are thought to be more commonly affected.5-7 In fact, acne affects up to 43% of pregnant women, and lesions typically extend beyond the face to involve the trunk.6,8-10 Importantly, one-third of women with a history of acne experience symptom relapse after disease-free periods, while two-thirds of those with ongoing disease experience symptom deterioration during pregnancy.10 Although acne is not a life-threatening condition, it has a well-documented, detrimental impact on social, emotional, and psychological well-being, namely self-perception, social interactions, quality-of-life scores, depression, and anxiety.11
Therefore, safe and effective treatment of pregnant women is of paramount importance. Because pregnant women are not included in clinical trials, there is a paucity of medication safety data, further augmented by inefficient access to available information. The US Food and Drug Administration (FDA) pregnancy safety categories were updated in 2015, letting go of the traditional A, B, C, D, and X categories.12 The Table reviews the current pregnancy classification system. In this narrative review, we summarize the most recent available data and recommendations on the safety and efficacy of acne treatment during pregnancy.
Topical Treatments for Acne
Benzoyl Peroxide—Benzoyl peroxide commonly is used as first-line therapy alone or in combination with other agents for the treatment of mild to moderate acne.13 It is safe for use during pregnancy.14 Although the medication is systemically absorbed, it undergoes complete metabolism to benzoic acid, a commonly used food additive.15,16 Benzoic acid has low bioavailability, as it gets rapidly metabolized by the kidneys; therefore, benzoyl peroxide is unlikely to reach clinically significant levels in the maternal circulation and consequently the fetal circulation. Additionally, it has a low risk for causing congenital malformations.17
Salicylic Acid—For mild to moderate acne, salicylic acid is a second-line agent that likely is safe for use by pregnant women at low concentrations and over limited body surface areas.14,18,19 There is minimal systemic absorption of the drug.20 Additionally, aspirin, which is broken down in the body into salicylic acid, is used in low doses for the treatment of pre-eclampsia during pregnancy.21
Dapsone—The use of dapsone gel 5% as a second-line agent has shown efficacy for mild to moderate acne.22 The oral formulation, commonly used for malaria and leprosy prophylaxis, has failed to show associated fetal toxicity or congenital anomalies.23,24 It also has been used as a first-line treatment for dermatitis herpetiformis in pregnancy.25 Although the medication likely is safe, it is better to minimize its use during the third trimester to reduce the theoretical risk for hyperbilirubinemia in the neonate.17,26-29
Azelaic Acid—Azelaic acid effectively targets noninflammatory and inflammatory acne and generally is well tolerated, harboring a good safety profile.30 Topical 20% azelaic acid has localized antibacterial and comedolytic effects and is safe for use during pregnancy.31,32
Glycolic Acid—Limited data exist on the safety of glycolic acid during pregnancy. In vitro studies have shown up to 27% systemic absorption depending on pH, concentration, and duration of application.33 Animal reproductive studies involving rats have shown fetal multisystem malformations and developmental abnormalities with oral administration of glycolic acid at doses far exceeding those used in humans.34 Although no human reproductive studies exist, topical glycolic acid is unlikely to reach the developing fetus in notable amounts, and the medication is likely safe for use.17,35
Clindamycin—Topical clindamycin phosphate is an effective and well-tolerated agent for the treatment of mild to moderate acne.36 Its systemic absorption is minimal, and it is considered safe for use during all trimesters of pregnancy.14,17,26,27,35,37
Erythromycin—Topical erythromycin is another commonly prescribed topical antibiotic used to target mild to moderate acne. However, its use recently has been associated with a decrease in efficacy secondary to the rise of antibacterial resistance in the community.38-40 Nevertheless, it remains a safe treatment for use during all trimesters of pregnancy.14,17,26,27,35,37
Topical Retinoids—Vitamin A derivatives (also known as retinoids) are the mainstay for the treatment of mild to moderate acne. Limited data exist regarding pregnancy outcomes after in utero exposure.41 A rare case report suggested topical tretinoin has been associated with fetal otocerebral anomalies.42 For tazarotene, teratogenic effects were seen in animal reproductive studies at doses exceeding maximum recommended human doses.41,43 However, a large meta-analysis failed to find a clear risk for increased congenital malformations, spontaneous abortions, stillbirth, elective termination of pregnancy, low birthweight, or prematurity following first-trimester exposure to topical retinoids.44 As the level of exposure that could lead to teratogenicity in humans is unknown, avoidance of both tretinoin and tazarotene is recommended in pregnant women.41,45 Nevertheless, women inadvertently exposed should be reassured.44
Conversely, adapalene has been associated with 1 case of anophthalmia and agenesis of the optic chiasma in a fetus following exposure until 13 weeks’ gestation.46 However, a large, open-label trial prior to the patient transitioning from adapalene to over-the-counter treatment showed that the drug harbors a large and reassuring margin of safety and no risk for teratogenicity in a maximal usage trial and Pregnancy Safety Review.47 Therefore, adapalene gel 0.1% is a safe and effective medication for the treatment of acne in a nonprescription environment and does not pose harm to the fetus.
Clascoterone—Clascoterone is a novel topical antiandrogenic drug approved for the treatment of hormonal and inflammatory moderate to severe acne.48-51 Human reproductive data are limited to 1 case of pregnancy that occurred during phase 3 trial investigations, and no adverse outcomes were reported.51 Minimal systemic absorption follows topical use.52 Nonetheless, dose-independent malformations were reported in animal reproductive studies.53 As such, it remains better to avoid the use of clascoterone during pregnancy pending further safety data.
Minocycline Foam—Minocycline foam 4% is approved to treat inflammatory lesions of nonnodular moderate to severe acne in patients 9 years and older.54 Systemic absorption is minimal, and the drug has limited bioavailability with minimal systemic accumulation in the patient’s serum.55 Given this information, it is unlikely that topical minocycline will reach notable levels in the fetal serum or harbor teratogenic effects, as seen with the oral formulation.56 However, it may be best to avoid its use during the second and third trimesters given the potential risk for tooth discoloration in the fetus.57,58
Systemic Treatments for Acne
Isotretinoin—Isotretinoin is the most effective treatment for moderate to severe acne with a well-documented potential for long-term clearance.59 Its use during pregnancy is absolutely contraindicated, as the medication is a well-known teratogen. Associated congenital malformations include numerous craniofacial defects, cardiovascular and neurologic malformations, or thymic disorders that are estimated to affect 20% to 35% of infants exposed in utero.60 Furthermore, strict contraception use during treatment is mandated for patients who can become pregnant. It is recommended to wait at least 1 month and 1 menstrual cycle after medication discontinuation before attempting to conceive.17 Pregnancy termination is recommended if conception occurs during treatment with isotretinoin.
Spironolactone—Spironolactone is an androgen-receptor antagonist commonly prescribed off label for mild to severe acne in females.61,62 Spironolactone promotes the feminization of male fetuses and should be avoided in pregnancy.63
Doxycycline/Minocycline—Tetracyclines are the most commonly prescribed oral antibiotics for moderate to severe acne.64 Although highly effective at treating acne, tetracyclines generally should be avoided in pregnancy. First-trimester use of doxycycline is not absolutely contraindicated but should be reserved for severe illness and not employed for the treatment of acne. However, accidental exposure to doxycycline has not been associated with congenital malformations.65 Nevertheless, after the 15th week of gestation, permanent tooth discoloration and bone growth inhibition in the fetus are serious and well-documented risks.14,17 Additional adverse events following in utero exposure include infantile inguinal hernia, hypospadias, and limb hypoplasia.63
Sarecycline—Sarecycline is a novel tetracycline-class antibiotic for the treatment of moderate to severe inflammatory acne. It has a narrower spectrum of activity compared to its counterparts within its class, which translates to an improved safety profile, namely when it comes to gastrointestinal tract microbiome disruption and potentially decreased likelihood of developing bacterial resistance.66 Data on human reproductive studies are limited, but it is advisable to avoid sarecycline in pregnancy, as it may cause adverse developmental effects in the fetus, such as reduced bone growth, in addition to the well-known tetracycline-associated risk for permanent discoloration of the teeth if used during the second and third trimesters.67,68
Erythromycin—Oral erythromycin targets moderate to severe inflammatory acne and is considered safe for use during pregnancy.69,70 There has been 1 study reporting an increased risk for atrial and ventricular septal defects (1.8%) and pyloric stenosis (0.2%), but these risks are still uncertain, and erythromycin is considered compatible with pregnancy.71 However, erythromycin estolate formulations should be avoided given the associated 10% to 15% risk for reversible cholestatic liver injury.72 Erythromycin base or erythromycin ethylsuccinate formulations should be favored.
Systemic Steroids—Prednisone is indicated for severe acne with scarring and should only be used during pregnancy after clearance from the patient’s obstetrician. Doses of 0.5 mg/kg or less should be prescribed in combination with systemic antibiotics as well as agents for bone and gastrointestinal tract prophylaxis.29
Zinc—The exact mechanism by which zinc exerts its effects to improve acne remains largely obscure. It has been found effective against inflammatory lesions of mild to moderate acne.73 Generally recommended dosages range from 30 to 200 mg/d but may be associated with gastrointestinal tract disturbances. Dosages of 75 mg/d have shown no harm to the fetus.74 When taking this supplement, patients should not exceed the recommended doses given the risk for hypocupremia associated with high-dose zinc supplementation.
Light-Based Therapies
Phototherapy—Narrowband UVB phototherapy is effective for the treatment of mild to moderate acne.75 It has been proven to be a safe treatment option during pregnancy, but its use has been associated with decreased folic acid levels.76-79 Therefore, in addition to attaining baseline folic acid serum levels, supplementation with folic acid prior to treatment, as per routine prenatal guidelines, should be sought.80
AviClear—The AviClear (Cutera) laser is the first device cleared by the FDA for mild to severe acne in March 2022.81 The FDA clearance for the Accure (Accure Acne Inc) laser, also targeting mild to severe acne, followed soon after (November 2022). Both lasers harbor a wavelength of 1726 nm and target sebaceous glands with electrothermolysis.82,83 Further research and long-term safety data are required before using them in pregnancy.
Other Therapies
Cosmetic Peels—Glycolic acid peels induce epidermolysis and desquamation.84 Although data on use during pregnancy are limited, these peels have limited dermal penetration and are considered safe for use in pregnancy.33,85,86 Similarly, keratolytic lactic acid peels harbor limited dermal penetration and can be safely used in pregnant women.87-89 Salicylic acid peels also work through epidermolysis and desquamation84; however, they tend to penetrate deeper into the skin, reaching down to the basal layer, if large areas are treated or when applied under occlusion.86,90 Although their use is not contraindicated in pregnancy, they should be limited to small areas of coverage.91
Intralesional Triamcinolone—Acne cysts and inflammatory papules can be treated with intralesional triamcinolone injections to relieve acute symptoms such as pain.92 Low doses at concentrations of 2.5 mg/mL are considered compatible with pregnancy when indicated.29
Approaching the Patient Clinical Encounter
In patients seeking treatment prior to conception, a few recommendations can be made to minimize the risk for acne recurrence or flares during pregnancy. For instance, because data show an association between increased acne severity in those with a higher body mass index and in pregnancy, weight loss may be recommended prior to pregnancy to help mitigate symptoms after conception.7 The Figure summarizes our recommendations for approaching and treating acne in pregnancy.
In all patients, grading the severity of the patient’s acne as mild, moderate, or severe is the first step. The presence of scarring is an additional consideration during the physical examination and should be documented. A careful discussion of treatment expectations and prognosis should be the focus before treatment initiation. Meticulous documentation of the physical examination and discussion with the patient should be prioritized.
To minimize toxicity and risks to the developing fetus, monotherapy is favored. Topical therapy should be considered first line. Safe regimens include mild nonabrasive washes, such as those containing benzoyl peroxide or glycolic acid, or topical azelaic acid or clindamycin phosphate for mild to moderate acne. More severe cases warrant the consideration of systemic medications as second line, as more severe acne is better treated with oral antibiotics such as the macrolides erythromycin or clindamycin or systemic corticosteroids when concern exists for severe scarring. The additional use of physical sunscreen also is recommended.
An important topic to address during the clinical encounter is cautious intake of oral supplements for acne during pregnancy, as they may contain harmful and teratogenic ingredients. A recent search focusing on acne supplements available online between March and May 2020 uncovered 49 different supplements, 26 (53%) of which contained vitamin A.93 Importantly, 3 (6%) of these 49 supplements were likely teratogenic, 4 (8%) contained vitamin A doses exceeding the recommended daily nutritional intake level, and 15 (31%) harbored an unknown teratogenic risk. Furthermore, among the 6 (12%) supplements with vitamin A levels exceeding 10,000 IU, 2 lacked any mention of pregnancy warning, including the supplement with the highest vitamin A dose found in this study.93 Because dietary supplements are not subject to the same stringent regulations by the FDA as drugs, inadvertent use by unaware patients ought to be prevented by careful counseling and education.
Finally, patients should be counseled to seek care following delivery for potentially updated medication management of acne, especially if they are breastfeeding. Co-management with a pediatrician may be indicated during lactation, particularly when newborns are born preterm or with other health conditions that may warrant additional caution with the use of certain agents.
- Bhate K, Williams H. Epidemiology of acne vulgaris. Br J Dermatol. 2013;168:474-485.
- Heng AHS, Chew FT. Systematic review of the epidemiology of acne vulgaris. Sci Rep. 2020;10:5754.
- Fisk WA, Lev-Tov HA, Sivamani RK. Epidemiology and management of acne in adult women. Curr Dermatol Rep. 2014;3:29-39.
- Perkins A, Cheng C, Hillebrand G, et al. Comparison of the epidemiology of acne vulgaris among Caucasian, Asian, Continental Indian and African American women. J Eur Acad Dermatol Venereol. 2011;25:1054-1060.
- Yang CC, Huang YT, Yu CH, et al. Inflammatory facial acne during uncomplicated pregnancy and post‐partum in adult women: a preliminary hospital‐based prospective observational study of 35 cases from Taiwan. J Eur Acad Dermatol Venereol. 2016;30:1787-1789.
- Dréno B, Blouin E, Moyse D, et al. Acne in pregnant women: a French survey. Acta Derm Venereol. 2014;94:82-83.
- Kutlu Ö, Karadag˘ AS, Ünal E, et al. Acne in pregnancy: a prospective multicenter, cross‐sectional study of 295 patients in Turkey. Int J Dermatol. 2020;59:1098-1105.
- Hoefel IDR, Weber MB, Manzoni APD, et al. Striae gravidarum, acne, facial spots, and hair disorders: risk factors in a study with 1284 puerperal patients. J Pregnancy. 2020;2020:8036109.
- Ayanlowo OO, Otrofanowei E, Shorunmu TO, et al. Pregnancy dermatoses: a study of patients attending the antenatal clinic at two tertiary care centers in south west Nigeria. PAMJ Clin Med. 2020;3.
- Bechstein S, Ochsendorf F. Acne and rosacea in pregnancy. Hautarzt. 2017;68:111-119.
- Habeshian KA, Cohen BA. Current issues in the treatment of acne vulgaris. Pediatrics. 2020;145(suppl 2):S225-S230.
- Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling (21 CFR 201). Fed Regist. 2014;79:72064-72103.
- Sagransky M, Yentzer BA, Feldman SR. Benzoyl peroxide: a review of its current use in the treatment of acne vulgaris. Expert Opin Pharmacother. 2009;10:2555-2562.
- Murase JE, Heller MM, Butler DC. Safety of dermatologic medications in pregnancy and lactation: part I. Pregnancy. J Am Acad Dermatol. 2014;70:401.e1-401.e14; quiz 415.
- Wolverton SE. Systemic corticosteroids. Comprehensive Dermatol Drug Ther. 2012;3:143-168.
- Kirtschig G, Schaefer C. Dermatological medications and local therapeutics. In: Schaefer C, Peters P, Miller RK, eds. Drugs During Pregnancy and Lactation. 3rd edition. Elsevier; 2015:467-492.
- Pugashetti R, Shinkai K. Treatment of acne vulgaris in pregnant patients. Dermatol Ther. 2013;26:302-311.
- Touitou E, Godin B, Shumilov M, et al. Efficacy and tolerability of clindamycin phosphate and salicylic acid gel in the treatment of mild to moderate acne vulgaris. J Eur Acad Dermatol Venereol. 2008;22:629-631.
- Schaefer C, Peters PW, Miller RK, eds. Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment. 2nd ed. Academic Press; 2014.
- Birmingham B, Greene D, Rhodes C. Systemic absorption of topical salicylic acid. Int J Dermatol. 1979;18:228-231.
- Trivedi NA. A meta-analysis of low-dose aspirin for prevention of preeclampsia. J Postgrad Med. 2011;57:91-95.
- Lucky AW, Maloney JM, Roberts J, et al. Dapsone gel 5% for the treatment of acne vulgaris: safety and efficacy of long-term (1 year) treatment. J Drugs Dermatol. 2007;6:981-987.
- Nosten F, McGready R, d’Alessandro U, et al. Antimalarial drugs in pregnancy: a review. Curr Drug Saf. 2006;1:1-15.
- Brabin BJ, Eggelte TA, Parise M, et al. Dapsone therapy for malaria during pregnancy: maternal and fetal outcomes. Drug Saf. 2004;27:633-648.
- Tuffanelli DL. Successful pregnancy in a patient with dermatitis herpetiformis treated with low-dose dapsone. Arch Dermatol. 1982;118:876.
- Meredith FM, Ormerod AD. The management of acne vulgaris in pregnancy. Am J Clin Dermatol. 2013;14:351-358.
- Kong Y, Tey H. Treatment of acne vulgaris during pregnancy and lactation. Drugs. 2013;73:779-787.
- Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006;24:167-197.
- Ly S, Kamal K, Manjaly P, et al. Treatment of acne vulgaris during pregnancy and lactation: a narrative review. Dermatol Ther. 2023;13:115-130.
- Webster G. Combination azelaic acid therapy for acne vulgaris. J Am Acad Dermatol. 2000;43:S47-S50.
- Archer CB, Cohen SN, Baron SE. Guidance on the diagnosis and clinical management of acne. Clin Exp Dermatol. 2012;37(suppl 1):1-6.
- Graupe K, Cunliffe W, Gollnick H, et al. Efficacy and safety of topical azelaic acid (20 percent cream): an overview of results from European clinical trials and experimental reports. Cutis. 1996;57(1 suppl):20-35.
- Bozzo P, Chua-Gocheco A, Einarson A. Safety of skin care products during pregnancy. Can Fam Physician. 2011;57:665-667.
- Munley SM, Kennedy GL, Hurtt ME. Developmental toxicity study of glycolic acid in rats. Drug Chem Toxicol. 1999;22:569-582.
- Chien AL, Qi J, Rainer B, et al. Treatment of acne in pregnancy. J Am Board Fam Med. 2016;29:254-262.
- Stuart B, Maund E, Wilcox C, et al. Topical preparations for the treatment of mild‐to‐moderate acne vulgaris: systematic review and network meta‐analysis. Br J Dermatol. 2021;185:512-525.
- van Hoogdalem EJ, Baven TL, Spiegel‐Melsen I, et al. Transdermal absorption of clindamycin and tretinoin from topically applied anti‐acne formulations in man. Biopharm Drug Dispos. 1998;19:563-569.
- Austin BA, Fleischer AB Jr. The extinction of topical erythromycin therapy for acne vulgaris and concern for the future of topical clindamycin. J Dermatolog Treat. 2017;28:145-148.
- Eady EA, Cove J, Holland K, et al. Erythromycin resistant propionibacteria in antibiotic treated acne patients: association with therapeutic failure. Br J. Dermatol. 1989;121:51-57.
- Alkhawaja E, Hammadi S, Abdelmalek M, et al. Antibiotic resistant Cutibacterium acnes among acne patients in Jordan: a cross sectional study. BMC Dermatol. 2020;20:1-9.
- Han G, Wu JJ, Del Rosso JQ. Use of topical tazarotene for the treatment of acne vulgaris in pregnancy: a literature review. J Clin Aesthet Dermatol. 2020;13:E59-E65.
- Selcen D, Seidman S, Nigro MA. Otocerebral anomalies associated with topical tretinoin use. Brain Dev. 2000;22:218-220.
- Moretz D. Drug Class Update with New Drug Evaluations: Topical Products for Inflammatory Skin Conditions. Oregon State University Drug Use & Research Management Program; December 2022. Accessed January 8, 2024. https://www.orpdl.org/durm/meetings/meetingdocs/2022_12_01/archives/2022_12_01_Inflammatory_Skin_Dz_ClassUpdate.pdf
- Kaplan YC, Ozsarfati J, Etwel F, et al. Pregnancy outcomes following first‐trimester exposure to topical retinoids: a systematic review and meta‐analysis. Br J Dermatol. 2015;173:1132-1141.
- Menter A. Pharmacokinetics and safety of tazarotene. J Am Acad Dermatol. 2000;43(2, pt 3):S31-S35.
- Autret E, Berjot M, Jonville-Béra A-P, et al. Anophthalmia and agenesis of optic chiasma associated with adapalene gel in early pregnancy. Lancet. 1997;350:339.
- Weiss J, Mallavalli S, Meckfessel M, et al. Safe use of adapalene 0.1% gel in a non-prescription environment. J Drugs Dermatol. 2021;20:1330-1335.
- Alessandro Mazzetti M. A phase 2b, randomized, double-blind vehicle controlled, dose escalation study evaluating clascoterone 0.1%, 0.5%, and 1% topical cream in subjects with facial acne. J Drugs Dermatol. 2019;18:570-575.
- Eichenfield L, Hebert A, Gold LS, et al. Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris. J Am Acad Dermatol. 2020;83:477-485.
- Trifu V, Tiplica GS, Naumescu E, et al. Cortexolone 17α‐propionate 1% cream, a new potent antiandrogen for topical treatment of acne vulgaris. a pilot randomized, double‐blind comparative study vs. placebo and tretinoin 0.05% cream. Br J Dermatol. 2011;165:177-183.
- Hebert A, Thiboutot D, Gold LS, et al. Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials. JAMA Dermatol. 2020;156:621-630.
- Alkhodaidi ST, Al Hawsawi KA, Alkhudaidi IT, et al. Efficacy and safety of topical clascoterone cream for treatment of acne vulgaris: a systematic review and meta‐analysis of randomized placebo‐controlled trials. Dermatol Ther. 2021;34:e14609.
- Clasoterone. Package insert. Cassiopea Inc; 2020.
- Paik J. Topical minocycline foam 4%: a review in acne vulgaris. Am J Clin Dermatol. 2020;21:449-456.
- Jones TM, Ellman H. Pharmacokinetic comparison of once-daily topical minocycline foam 4% vs oral minocycline for moderate-to-severe acne. J Drugs Dermatol. 2017;16:1022-1028.
- Minocycline hydrochloride extended-release tablets. Package insert. JG Pharma; July 2020. Accessed January 8, 2024. https://www.jgpharmainc.com/assets/pdf/minocycline-hydrochloride.pdf
- Dinnendahl V, Fricke U (eds). Arzneistoff-Profile: Basisinformation über arzneiliche Wirkstoffe. Govi Pharmazeutischer Verlag; 2010.
- Martins AM, Marto JM, Johnson JL, et al. A review of systemic minocycline side effects and topical minocycline as a safer alternative for treating acne and rosacea. Antibiotics. 2021;10:757.
- Landis MN. Optimizing isotretinoin treatment of acne: update on current recommendations for monitoring, dosing, safety, adverse effects, compliance, and outcomes. Am J Clin Dermatol. 2020;21:411-419.
- Draghici C-C, Miulescu R-G, Petca R-C, et al. Teratogenic effect of isotretinoin in both fertile females and males. Exp Ther Med. 2021;21:1-5.
- Barker RA, Wilcox C, Layton AM. Oral spironolactone for acne vulgaris in adult females: an update of the literature. Am J Clin Dermatol. 2020;21:303-305.
- Han JJ, Faletsky A, Barbieri JS, et al. New acne therapies and updates on use of spironolactone and isotretinoin: a narrative review. Dermatol Ther (Heidelb). 2021;11:79-91.
- Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Lippincott Williams & Wilkins; 2012.
- Patel DJ, Bhatia N. Oral antibiotics for acne. Am J Clin Dermatol. 2021;22:193-204.
- Jick H, Holmes LB, Hunter JR, et al. First-trimester drug use and congenital disorders. JAMA. 1981;246:343-346.
- Valente Duarte de Sousa IC. An overview of sarecycline for the treatment of moderate-to-severe acne vulgaris. Exp Opin Pharmacother. 2021;22:145-154.
- Hussar DA, Chahine EB. Omadacycline tosylate, sarecycline hydrochloride, rifamycin sodium, and moxidectin. J Am Pharm Assoc. 2019;59:756-760.
- Haidari W, Bruinsma R, Cardenas-de la Garza JA, et al. Sarecycline review. Ann Pharmacother. 2020;54:164-170.
- Feldman S, Careccia RE, Barham KL, et al. Diagnosis and treatment of acne. Am Fam Physician. 2004;69:2123-2130.
- Gammon WR, Meyer C, Lantis S, et al. Comparative efficacy of oral erythromycin versus oral tetracycline in the treatment of acne vulgaris: a double-blind study. J Am Acad Dermatol. 1986;14:183-186.
- Källén BA, Olausson PO, Danielsson BR. Is erythromycin therapy teratogenic in humans? Reprod Toxicol. 2005;20:209-214.
- McCormack WM, George H, Donner A, et al. Hepatotoxicity of erythromycin estolate during pregnancy. Antimicrob Agents Chemother. 1977;12:630-635.
- Cervantes J, Eber AE, Perper M, et al. The role of zinc in the treatment of acne: a review of the literature. Dermatolog Ther. 2018;31:e12576.
- Dréno B, Blouin E. Acne, pregnant women and zinc salts: a literature review [in French]. Ann Dermatol Venereol. 2008;135:27-33.
- Eid MM, Saleh MS, Allam NM, et al. Narrow band ultraviolet B versus red light-emitting diodes in the treatment of facial acne vulgaris: a randomized controlled trial. Photobiomodul Photomed Laser Surg. 2021;39:418-424.
- Zeichner JA. Narrowband UV-B phototherapy for the treatment of acne vulgaris during pregnancy. Arch Dermatol. 2011;147:537-539.
- El-Saie LT, Rabie AR, Kamel MI, et al. Effect of narrowband ultraviolet B phototherapy on serum folic acid levels in patients with psoriasis. Lasers Med Sci. 2011;26:481-485.
- Park KK, Murase JE. Narrowband UV-B phototherapy during pregnancy and folic acid depletion. Arch Dermatol. 2012;148:132-133.
- Jablonski NG. A possible link between neural tube defects and ultraviolet light exposure. Med Hypotheses. 1999;52:581-582.
- Zhang M, Goyert G, Lim HW. Folate and phototherapy: what should we inform our patients? J Am Acad Dermatol. 2017;77:958-964.
- AviClear. Cutera website. Accessed January 8, 2024. https://www.cutera.com/solutions/aviclear/
- Wu X, Yang Y, Wang Y, et al. Treatment of refractory acne using selective sebaceous gland electro-thermolysis combined with non-thermal plasma. J Cosmet Laser Ther. 2021;23:188-194.
- Ahn GR, Kim JM, Park SJ, et al. Selective sebaceous gland electrothermolysis using a single microneedle radiofrequency device for acne patients: a prospective randomized controlled study. Lasers Surg Med. 2020;52:396-401.
- Fabbrocini G, De Padova MP, Tosti A. Chemical peels: what’s new and what isn’t new but still works well. Facial Plast Surg. 2009;25:329-336.
- Andersen FA. Final report on the safety assessment of glycolic acid, ammonium, calcium, potassium, and sodium glycolates, methyl, ethyl, propyl, and butyl glycolates, and lactic acid, ammonium, calcium, potassium, sodium, and TEA-lactates, methyl, ethyl, isopropyl, and butyl lactates, and lauryl, myristyl, and cetyl lactates. Int J Toxicol. 1998;17(1_suppl):1-241.
- Lee KC, Korgavkar K, Dufresne RG Jr, et al. Safety of cosmetic dermatologic procedures during pregnancy. Dermatol Surg. 2013;39:1573-1586.
- James AH, Brancazio LR, Price T. Aspirin and reproductive outcomes. Obstet Gynecol Surv. 2008;63:49-57.
- Zhou W-S, Xu L, Xie S-H, et al. Decreased birth weight in relation to maternal urinary trichloroacetic acid levels. Sci Total Environ. 2012;416:105-110.
- Schwartz DB, Greenberg MD, Daoud Y, et al. Genital condylomas in pregnancy: use of trichloroacetic acid and laser therapy. Am J Obstet Gynecol. 1988;158:1407-1416.
- Starkman SJ, Mangat DS. Chemical peel (deep, medium, light). Facial Plast Surg Clin North Am. 2020;28:45-57.
- Trivedi M, Kroumpouzos G, Murase J. A review of the safety of cosmetic procedures during pregnancy and lactation. Int J Womens Dermatol. 2017;3:6-10.
- Gallagher T, Taliercio M, Nia JK, et al. Dermatologist use of intralesional triamcinolone in the treatment of acne. J Clin Aesthet Dermatol. 2020;13:41-43.
- Zamil DH, Burns EK, Perez-Sanchez A, et al. Risk of birth defects from vitamin A “acne supplements” sold online. Dermatol Pract Concept. 2021;11:e2021075.
- Bhate K, Williams H. Epidemiology of acne vulgaris. Br J Dermatol. 2013;168:474-485.
- Heng AHS, Chew FT. Systematic review of the epidemiology of acne vulgaris. Sci Rep. 2020;10:5754.
- Fisk WA, Lev-Tov HA, Sivamani RK. Epidemiology and management of acne in adult women. Curr Dermatol Rep. 2014;3:29-39.
- Perkins A, Cheng C, Hillebrand G, et al. Comparison of the epidemiology of acne vulgaris among Caucasian, Asian, Continental Indian and African American women. J Eur Acad Dermatol Venereol. 2011;25:1054-1060.
- Yang CC, Huang YT, Yu CH, et al. Inflammatory facial acne during uncomplicated pregnancy and post‐partum in adult women: a preliminary hospital‐based prospective observational study of 35 cases from Taiwan. J Eur Acad Dermatol Venereol. 2016;30:1787-1789.
- Dréno B, Blouin E, Moyse D, et al. Acne in pregnant women: a French survey. Acta Derm Venereol. 2014;94:82-83.
- Kutlu Ö, Karadag˘ AS, Ünal E, et al. Acne in pregnancy: a prospective multicenter, cross‐sectional study of 295 patients in Turkey. Int J Dermatol. 2020;59:1098-1105.
- Hoefel IDR, Weber MB, Manzoni APD, et al. Striae gravidarum, acne, facial spots, and hair disorders: risk factors in a study with 1284 puerperal patients. J Pregnancy. 2020;2020:8036109.
- Ayanlowo OO, Otrofanowei E, Shorunmu TO, et al. Pregnancy dermatoses: a study of patients attending the antenatal clinic at two tertiary care centers in south west Nigeria. PAMJ Clin Med. 2020;3.
- Bechstein S, Ochsendorf F. Acne and rosacea in pregnancy. Hautarzt. 2017;68:111-119.
- Habeshian KA, Cohen BA. Current issues in the treatment of acne vulgaris. Pediatrics. 2020;145(suppl 2):S225-S230.
- Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling (21 CFR 201). Fed Regist. 2014;79:72064-72103.
- Sagransky M, Yentzer BA, Feldman SR. Benzoyl peroxide: a review of its current use in the treatment of acne vulgaris. Expert Opin Pharmacother. 2009;10:2555-2562.
- Murase JE, Heller MM, Butler DC. Safety of dermatologic medications in pregnancy and lactation: part I. Pregnancy. J Am Acad Dermatol. 2014;70:401.e1-401.e14; quiz 415.
- Wolverton SE. Systemic corticosteroids. Comprehensive Dermatol Drug Ther. 2012;3:143-168.
- Kirtschig G, Schaefer C. Dermatological medications and local therapeutics. In: Schaefer C, Peters P, Miller RK, eds. Drugs During Pregnancy and Lactation. 3rd edition. Elsevier; 2015:467-492.
- Pugashetti R, Shinkai K. Treatment of acne vulgaris in pregnant patients. Dermatol Ther. 2013;26:302-311.
- Touitou E, Godin B, Shumilov M, et al. Efficacy and tolerability of clindamycin phosphate and salicylic acid gel in the treatment of mild to moderate acne vulgaris. J Eur Acad Dermatol Venereol. 2008;22:629-631.
- Schaefer C, Peters PW, Miller RK, eds. Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment. 2nd ed. Academic Press; 2014.
- Birmingham B, Greene D, Rhodes C. Systemic absorption of topical salicylic acid. Int J Dermatol. 1979;18:228-231.
- Trivedi NA. A meta-analysis of low-dose aspirin for prevention of preeclampsia. J Postgrad Med. 2011;57:91-95.
- Lucky AW, Maloney JM, Roberts J, et al. Dapsone gel 5% for the treatment of acne vulgaris: safety and efficacy of long-term (1 year) treatment. J Drugs Dermatol. 2007;6:981-987.
- Nosten F, McGready R, d’Alessandro U, et al. Antimalarial drugs in pregnancy: a review. Curr Drug Saf. 2006;1:1-15.
- Brabin BJ, Eggelte TA, Parise M, et al. Dapsone therapy for malaria during pregnancy: maternal and fetal outcomes. Drug Saf. 2004;27:633-648.
- Tuffanelli DL. Successful pregnancy in a patient with dermatitis herpetiformis treated with low-dose dapsone. Arch Dermatol. 1982;118:876.
- Meredith FM, Ormerod AD. The management of acne vulgaris in pregnancy. Am J Clin Dermatol. 2013;14:351-358.
- Kong Y, Tey H. Treatment of acne vulgaris during pregnancy and lactation. Drugs. 2013;73:779-787.
- Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006;24:167-197.
- Ly S, Kamal K, Manjaly P, et al. Treatment of acne vulgaris during pregnancy and lactation: a narrative review. Dermatol Ther. 2023;13:115-130.
- Webster G. Combination azelaic acid therapy for acne vulgaris. J Am Acad Dermatol. 2000;43:S47-S50.
- Archer CB, Cohen SN, Baron SE. Guidance on the diagnosis and clinical management of acne. Clin Exp Dermatol. 2012;37(suppl 1):1-6.
- Graupe K, Cunliffe W, Gollnick H, et al. Efficacy and safety of topical azelaic acid (20 percent cream): an overview of results from European clinical trials and experimental reports. Cutis. 1996;57(1 suppl):20-35.
- Bozzo P, Chua-Gocheco A, Einarson A. Safety of skin care products during pregnancy. Can Fam Physician. 2011;57:665-667.
- Munley SM, Kennedy GL, Hurtt ME. Developmental toxicity study of glycolic acid in rats. Drug Chem Toxicol. 1999;22:569-582.
- Chien AL, Qi J, Rainer B, et al. Treatment of acne in pregnancy. J Am Board Fam Med. 2016;29:254-262.
- Stuart B, Maund E, Wilcox C, et al. Topical preparations for the treatment of mild‐to‐moderate acne vulgaris: systematic review and network meta‐analysis. Br J Dermatol. 2021;185:512-525.
- van Hoogdalem EJ, Baven TL, Spiegel‐Melsen I, et al. Transdermal absorption of clindamycin and tretinoin from topically applied anti‐acne formulations in man. Biopharm Drug Dispos. 1998;19:563-569.
- Austin BA, Fleischer AB Jr. The extinction of topical erythromycin therapy for acne vulgaris and concern for the future of topical clindamycin. J Dermatolog Treat. 2017;28:145-148.
- Eady EA, Cove J, Holland K, et al. Erythromycin resistant propionibacteria in antibiotic treated acne patients: association with therapeutic failure. Br J. Dermatol. 1989;121:51-57.
- Alkhawaja E, Hammadi S, Abdelmalek M, et al. Antibiotic resistant Cutibacterium acnes among acne patients in Jordan: a cross sectional study. BMC Dermatol. 2020;20:1-9.
- Han G, Wu JJ, Del Rosso JQ. Use of topical tazarotene for the treatment of acne vulgaris in pregnancy: a literature review. J Clin Aesthet Dermatol. 2020;13:E59-E65.
- Selcen D, Seidman S, Nigro MA. Otocerebral anomalies associated with topical tretinoin use. Brain Dev. 2000;22:218-220.
- Moretz D. Drug Class Update with New Drug Evaluations: Topical Products for Inflammatory Skin Conditions. Oregon State University Drug Use & Research Management Program; December 2022. Accessed January 8, 2024. https://www.orpdl.org/durm/meetings/meetingdocs/2022_12_01/archives/2022_12_01_Inflammatory_Skin_Dz_ClassUpdate.pdf
- Kaplan YC, Ozsarfati J, Etwel F, et al. Pregnancy outcomes following first‐trimester exposure to topical retinoids: a systematic review and meta‐analysis. Br J Dermatol. 2015;173:1132-1141.
- Menter A. Pharmacokinetics and safety of tazarotene. J Am Acad Dermatol. 2000;43(2, pt 3):S31-S35.
- Autret E, Berjot M, Jonville-Béra A-P, et al. Anophthalmia and agenesis of optic chiasma associated with adapalene gel in early pregnancy. Lancet. 1997;350:339.
- Weiss J, Mallavalli S, Meckfessel M, et al. Safe use of adapalene 0.1% gel in a non-prescription environment. J Drugs Dermatol. 2021;20:1330-1335.
- Alessandro Mazzetti M. A phase 2b, randomized, double-blind vehicle controlled, dose escalation study evaluating clascoterone 0.1%, 0.5%, and 1% topical cream in subjects with facial acne. J Drugs Dermatol. 2019;18:570-575.
- Eichenfield L, Hebert A, Gold LS, et al. Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris. J Am Acad Dermatol. 2020;83:477-485.
- Trifu V, Tiplica GS, Naumescu E, et al. Cortexolone 17α‐propionate 1% cream, a new potent antiandrogen for topical treatment of acne vulgaris. a pilot randomized, double‐blind comparative study vs. placebo and tretinoin 0.05% cream. Br J Dermatol. 2011;165:177-183.
- Hebert A, Thiboutot D, Gold LS, et al. Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials. JAMA Dermatol. 2020;156:621-630.
- Alkhodaidi ST, Al Hawsawi KA, Alkhudaidi IT, et al. Efficacy and safety of topical clascoterone cream for treatment of acne vulgaris: a systematic review and meta‐analysis of randomized placebo‐controlled trials. Dermatol Ther. 2021;34:e14609.
- Clasoterone. Package insert. Cassiopea Inc; 2020.
- Paik J. Topical minocycline foam 4%: a review in acne vulgaris. Am J Clin Dermatol. 2020;21:449-456.
- Jones TM, Ellman H. Pharmacokinetic comparison of once-daily topical minocycline foam 4% vs oral minocycline for moderate-to-severe acne. J Drugs Dermatol. 2017;16:1022-1028.
- Minocycline hydrochloride extended-release tablets. Package insert. JG Pharma; July 2020. Accessed January 8, 2024. https://www.jgpharmainc.com/assets/pdf/minocycline-hydrochloride.pdf
- Dinnendahl V, Fricke U (eds). Arzneistoff-Profile: Basisinformation über arzneiliche Wirkstoffe. Govi Pharmazeutischer Verlag; 2010.
- Martins AM, Marto JM, Johnson JL, et al. A review of systemic minocycline side effects and topical minocycline as a safer alternative for treating acne and rosacea. Antibiotics. 2021;10:757.
- Landis MN. Optimizing isotretinoin treatment of acne: update on current recommendations for monitoring, dosing, safety, adverse effects, compliance, and outcomes. Am J Clin Dermatol. 2020;21:411-419.
- Draghici C-C, Miulescu R-G, Petca R-C, et al. Teratogenic effect of isotretinoin in both fertile females and males. Exp Ther Med. 2021;21:1-5.
- Barker RA, Wilcox C, Layton AM. Oral spironolactone for acne vulgaris in adult females: an update of the literature. Am J Clin Dermatol. 2020;21:303-305.
- Han JJ, Faletsky A, Barbieri JS, et al. New acne therapies and updates on use of spironolactone and isotretinoin: a narrative review. Dermatol Ther (Heidelb). 2021;11:79-91.
- Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Lippincott Williams & Wilkins; 2012.
- Patel DJ, Bhatia N. Oral antibiotics for acne. Am J Clin Dermatol. 2021;22:193-204.
- Jick H, Holmes LB, Hunter JR, et al. First-trimester drug use and congenital disorders. JAMA. 1981;246:343-346.
- Valente Duarte de Sousa IC. An overview of sarecycline for the treatment of moderate-to-severe acne vulgaris. Exp Opin Pharmacother. 2021;22:145-154.
- Hussar DA, Chahine EB. Omadacycline tosylate, sarecycline hydrochloride, rifamycin sodium, and moxidectin. J Am Pharm Assoc. 2019;59:756-760.
- Haidari W, Bruinsma R, Cardenas-de la Garza JA, et al. Sarecycline review. Ann Pharmacother. 2020;54:164-170.
- Feldman S, Careccia RE, Barham KL, et al. Diagnosis and treatment of acne. Am Fam Physician. 2004;69:2123-2130.
- Gammon WR, Meyer C, Lantis S, et al. Comparative efficacy of oral erythromycin versus oral tetracycline in the treatment of acne vulgaris: a double-blind study. J Am Acad Dermatol. 1986;14:183-186.
- Källén BA, Olausson PO, Danielsson BR. Is erythromycin therapy teratogenic in humans? Reprod Toxicol. 2005;20:209-214.
- McCormack WM, George H, Donner A, et al. Hepatotoxicity of erythromycin estolate during pregnancy. Antimicrob Agents Chemother. 1977;12:630-635.
- Cervantes J, Eber AE, Perper M, et al. The role of zinc in the treatment of acne: a review of the literature. Dermatolog Ther. 2018;31:e12576.
- Dréno B, Blouin E. Acne, pregnant women and zinc salts: a literature review [in French]. Ann Dermatol Venereol. 2008;135:27-33.
- Eid MM, Saleh MS, Allam NM, et al. Narrow band ultraviolet B versus red light-emitting diodes in the treatment of facial acne vulgaris: a randomized controlled trial. Photobiomodul Photomed Laser Surg. 2021;39:418-424.
- Zeichner JA. Narrowband UV-B phototherapy for the treatment of acne vulgaris during pregnancy. Arch Dermatol. 2011;147:537-539.
- El-Saie LT, Rabie AR, Kamel MI, et al. Effect of narrowband ultraviolet B phototherapy on serum folic acid levels in patients with psoriasis. Lasers Med Sci. 2011;26:481-485.
- Park KK, Murase JE. Narrowband UV-B phototherapy during pregnancy and folic acid depletion. Arch Dermatol. 2012;148:132-133.
- Jablonski NG. A possible link between neural tube defects and ultraviolet light exposure. Med Hypotheses. 1999;52:581-582.
- Zhang M, Goyert G, Lim HW. Folate and phototherapy: what should we inform our patients? J Am Acad Dermatol. 2017;77:958-964.
- AviClear. Cutera website. Accessed January 8, 2024. https://www.cutera.com/solutions/aviclear/
- Wu X, Yang Y, Wang Y, et al. Treatment of refractory acne using selective sebaceous gland electro-thermolysis combined with non-thermal plasma. J Cosmet Laser Ther. 2021;23:188-194.
- Ahn GR, Kim JM, Park SJ, et al. Selective sebaceous gland electrothermolysis using a single microneedle radiofrequency device for acne patients: a prospective randomized controlled study. Lasers Surg Med. 2020;52:396-401.
- Fabbrocini G, De Padova MP, Tosti A. Chemical peels: what’s new and what isn’t new but still works well. Facial Plast Surg. 2009;25:329-336.
- Andersen FA. Final report on the safety assessment of glycolic acid, ammonium, calcium, potassium, and sodium glycolates, methyl, ethyl, propyl, and butyl glycolates, and lactic acid, ammonium, calcium, potassium, sodium, and TEA-lactates, methyl, ethyl, isopropyl, and butyl lactates, and lauryl, myristyl, and cetyl lactates. Int J Toxicol. 1998;17(1_suppl):1-241.
- Lee KC, Korgavkar K, Dufresne RG Jr, et al. Safety of cosmetic dermatologic procedures during pregnancy. Dermatol Surg. 2013;39:1573-1586.
- James AH, Brancazio LR, Price T. Aspirin and reproductive outcomes. Obstet Gynecol Surv. 2008;63:49-57.
- Zhou W-S, Xu L, Xie S-H, et al. Decreased birth weight in relation to maternal urinary trichloroacetic acid levels. Sci Total Environ. 2012;416:105-110.
- Schwartz DB, Greenberg MD, Daoud Y, et al. Genital condylomas in pregnancy: use of trichloroacetic acid and laser therapy. Am J Obstet Gynecol. 1988;158:1407-1416.
- Starkman SJ, Mangat DS. Chemical peel (deep, medium, light). Facial Plast Surg Clin North Am. 2020;28:45-57.
- Trivedi M, Kroumpouzos G, Murase J. A review of the safety of cosmetic procedures during pregnancy and lactation. Int J Womens Dermatol. 2017;3:6-10.
- Gallagher T, Taliercio M, Nia JK, et al. Dermatologist use of intralesional triamcinolone in the treatment of acne. J Clin Aesthet Dermatol. 2020;13:41-43.
- Zamil DH, Burns EK, Perez-Sanchez A, et al. Risk of birth defects from vitamin A “acne supplements” sold online. Dermatol Pract Concept. 2021;11:e2021075.
Practice Points
- The management of acne in pregnancy requires careful consideration of therapeutic choices to guarantee the safety of both the mother and the developing fetus.
- The use of topicals should be observed as first-line therapy, but consideration for systemic therapy in cases of treatment failure or more severe disease is warranted.
- Discussion of patient expectations and involving them in decision-making for therapeutic choice is crucial.
Commentary: Drug Comparisons and Contact Allergy in AD, February 2024
But here's the thing: We should not be making clinical judgments on the basis of differences in relative risk; clinical decisions should be based on absolute risks. Should we worry about VTE risk when treating patients with AD? This paper did not focus on absolute risk, but we can get an idea of the absolute risk by looking at the data presented in the figures in the paper. The risk for VTE in patients without AD was about 1 in 400, whereas with AD the risk was about 1 in 300, even before controlling for risk factors. This rate is sufficiently low for both groups that it doesn't seem like this risk would affect whether we would use a drug that might be associated with some minimal or theoretical increased risk for VTE.
The bottom line is that the findings of this study are reassuring, at least to me.
I'm already convinced that dupilumab is a very safe treatment for our patients with AD. The study by Simpson and colleagues looked at data from a registry of patients followed in real-life practice. The 2-year study showed no new concerns for dupilumab treatment of AD. The most common adverse event was conjunctivitis, and that was seen in only 2.4% of the patients. Perhaps the most interesting finding was that 83% of the patients who started in the study were still on dupilumab treatment at the end of 2 years. Dupilumab has a good level of efficacy and safety such that the great majority of patients who start on it seem to do well.
Dupilumab is a highly effective, very safe treatment for AD. Rademikibart Is another interleukin-4 receptor alpha-chain blocker. Not surprisingly, rademikibart also seems to be an effective, safe treatment for AD (Silverberg et al). Rademikibart may serve as another option for AD, and I imagine that it could be used if a patient on dupilumab were to develop an anti-drug antibody and lose effectiveness.
The very interesting analysis by Silverberg and colleagues looks at a new way to compare the effectiveness of different drugs for AD. They use this new approach to compare upadacitinib and dupilumab. What they found, not surprisingly, was that upadacitinib was generally more effective for AD than dupilumab. I used to think I would never see anything more effective for AD than dupilumab, but, clearly, based on head-to-head trials, upadacitinib is more effective for AD than is dupilumab. But does that greater efficacy mean that we should use upadacitinib first? We need to consider safety, too. Dupilumab works well enough for the great majority of patients and is extremely safe. I think upadacitinib is a great choice for patients who did not respond to dupilumab and could also be considered for those patients who want to take the most effective treatment option.
Trimeche and colleagues' study of contact allergens in patients with AD may change how I practice. In this study, 60% of the AD patients had positive patch test results of which 71% were considered relevant. The most frequent allergens included textile dye mix (25%), nickel (20%), cobalt (13%), isothiazolinone (9%), quanterium-15 (4%), and balsam of Peru (4%). Two patients were allergic to corticosteroids. Avoidance of relevant allergens resulted in improvement. I need to warn my AD patients to be on the lookout for contact allergens that may be causing or exacerbating their skin disease.
But here's the thing: We should not be making clinical judgments on the basis of differences in relative risk; clinical decisions should be based on absolute risks. Should we worry about VTE risk when treating patients with AD? This paper did not focus on absolute risk, but we can get an idea of the absolute risk by looking at the data presented in the figures in the paper. The risk for VTE in patients without AD was about 1 in 400, whereas with AD the risk was about 1 in 300, even before controlling for risk factors. This rate is sufficiently low for both groups that it doesn't seem like this risk would affect whether we would use a drug that might be associated with some minimal or theoretical increased risk for VTE.
The bottom line is that the findings of this study are reassuring, at least to me.
I'm already convinced that dupilumab is a very safe treatment for our patients with AD. The study by Simpson and colleagues looked at data from a registry of patients followed in real-life practice. The 2-year study showed no new concerns for dupilumab treatment of AD. The most common adverse event was conjunctivitis, and that was seen in only 2.4% of the patients. Perhaps the most interesting finding was that 83% of the patients who started in the study were still on dupilumab treatment at the end of 2 years. Dupilumab has a good level of efficacy and safety such that the great majority of patients who start on it seem to do well.
Dupilumab is a highly effective, very safe treatment for AD. Rademikibart Is another interleukin-4 receptor alpha-chain blocker. Not surprisingly, rademikibart also seems to be an effective, safe treatment for AD (Silverberg et al). Rademikibart may serve as another option for AD, and I imagine that it could be used if a patient on dupilumab were to develop an anti-drug antibody and lose effectiveness.
The very interesting analysis by Silverberg and colleagues looks at a new way to compare the effectiveness of different drugs for AD. They use this new approach to compare upadacitinib and dupilumab. What they found, not surprisingly, was that upadacitinib was generally more effective for AD than dupilumab. I used to think I would never see anything more effective for AD than dupilumab, but, clearly, based on head-to-head trials, upadacitinib is more effective for AD than is dupilumab. But does that greater efficacy mean that we should use upadacitinib first? We need to consider safety, too. Dupilumab works well enough for the great majority of patients and is extremely safe. I think upadacitinib is a great choice for patients who did not respond to dupilumab and could also be considered for those patients who want to take the most effective treatment option.
Trimeche and colleagues' study of contact allergens in patients with AD may change how I practice. In this study, 60% of the AD patients had positive patch test results of which 71% were considered relevant. The most frequent allergens included textile dye mix (25%), nickel (20%), cobalt (13%), isothiazolinone (9%), quanterium-15 (4%), and balsam of Peru (4%). Two patients were allergic to corticosteroids. Avoidance of relevant allergens resulted in improvement. I need to warn my AD patients to be on the lookout for contact allergens that may be causing or exacerbating their skin disease.
But here's the thing: We should not be making clinical judgments on the basis of differences in relative risk; clinical decisions should be based on absolute risks. Should we worry about VTE risk when treating patients with AD? This paper did not focus on absolute risk, but we can get an idea of the absolute risk by looking at the data presented in the figures in the paper. The risk for VTE in patients without AD was about 1 in 400, whereas with AD the risk was about 1 in 300, even before controlling for risk factors. This rate is sufficiently low for both groups that it doesn't seem like this risk would affect whether we would use a drug that might be associated with some minimal or theoretical increased risk for VTE.
The bottom line is that the findings of this study are reassuring, at least to me.
I'm already convinced that dupilumab is a very safe treatment for our patients with AD. The study by Simpson and colleagues looked at data from a registry of patients followed in real-life practice. The 2-year study showed no new concerns for dupilumab treatment of AD. The most common adverse event was conjunctivitis, and that was seen in only 2.4% of the patients. Perhaps the most interesting finding was that 83% of the patients who started in the study were still on dupilumab treatment at the end of 2 years. Dupilumab has a good level of efficacy and safety such that the great majority of patients who start on it seem to do well.
Dupilumab is a highly effective, very safe treatment for AD. Rademikibart Is another interleukin-4 receptor alpha-chain blocker. Not surprisingly, rademikibart also seems to be an effective, safe treatment for AD (Silverberg et al). Rademikibart may serve as another option for AD, and I imagine that it could be used if a patient on dupilumab were to develop an anti-drug antibody and lose effectiveness.
The very interesting analysis by Silverberg and colleagues looks at a new way to compare the effectiveness of different drugs for AD. They use this new approach to compare upadacitinib and dupilumab. What they found, not surprisingly, was that upadacitinib was generally more effective for AD than dupilumab. I used to think I would never see anything more effective for AD than dupilumab, but, clearly, based on head-to-head trials, upadacitinib is more effective for AD than is dupilumab. But does that greater efficacy mean that we should use upadacitinib first? We need to consider safety, too. Dupilumab works well enough for the great majority of patients and is extremely safe. I think upadacitinib is a great choice for patients who did not respond to dupilumab and could also be considered for those patients who want to take the most effective treatment option.
Trimeche and colleagues' study of contact allergens in patients with AD may change how I practice. In this study, 60% of the AD patients had positive patch test results of which 71% were considered relevant. The most frequent allergens included textile dye mix (25%), nickel (20%), cobalt (13%), isothiazolinone (9%), quanterium-15 (4%), and balsam of Peru (4%). Two patients were allergic to corticosteroids. Avoidance of relevant allergens resulted in improvement. I need to warn my AD patients to be on the lookout for contact allergens that may be causing or exacerbating their skin disease.
Even Intentional Weight Loss Linked With Cancer
This transcript has been edited for clarity.
As anyone who has been through medical training will tell you, some little scenes just stick with you. I had been seeing a patient in our resident clinic in West Philly for a couple of years. She was in her mid-60s with diabetes and hypertension and a distant smoking history. She was overweight and had been trying to improve her diet and lose weight since I started seeing her. One day she came in and was delighted to report that she had finally started shedding some pounds — about 15 in the past 2 months.
I enthusiastically told my preceptor that my careful dietary counseling had finally done the job. She looked through the chart for a moment and asked, “Is she up to date on her cancer screening?” A workup revealed adenocarcinoma of the lung. The patient did well, actually, but the story stuck with me.
The textbooks call it “unintentional weight loss,” often in big, scary letters, and every doctor will go just a bit pale if a patient tells them that, despite efforts not to, they are losing weight. But true unintentional weight loss is not that common. After all, most of us are at least half-heartedly trying to lose weight all the time. Should doctors be worried when we are successful?
A new study suggests that perhaps they should. We’re talking about this study, appearing in JAMA, which combined participants from two long-running observational cohorts: 120,000 women from the Nurses’ Health Study, and 50,000 men from the Health Professionals Follow-Up Study. (These cohorts started in the 1970s and 1980s, so we’ll give them a pass on the gender-specific study designs.)
The rationale of enrolling healthcare providers in these cohort studies is that they would be reliable witnesses of their own health status. If a nurse or doctor says they have pancreatic cancer, it’s likely that they truly have pancreatic cancer. Detailed health surveys were distributed to the participants every other year, and the average follow-up was more than a decade.
Participants recorded their weight — as an aside, a nested study found that self-reported rate was extremely well correlated with professionally measured weight — and whether they had received a cancer diagnosis since the last survey.
This allowed researchers to look at the phenomenon described above. Would weight loss precede a new diagnosis of cancer? And, more interestingly, would intentional weight loss precede a new diagnosis of cancer.
I don’t think it will surprise you to hear that individuals in the highest category of weight loss, those who lost more than 10% of their body weight over a 2-year period, had a larger risk of being diagnosed with cancer in the next year. That’s the yellow line in this graph. In fact, they had about a 40% higher risk than those who did not lose weight.
Increased risk was found across multiple cancer types, though cancers of the gastrointestinal tract, not surprisingly, were most strongly associated with antecedent weight loss.
What about intentionality of weight loss? Unfortunately, the surveys did not ask participants whether they were trying to lose weight. Rather, the surveys asked about exercise and dietary habits. The researchers leveraged these responses to create three categories of participants: those who seemed to be trying to lose weight (defined as people who had increased their exercise and dietary quality); those who didn’t seem to be trying to lose weight (they changed neither exercise nor dietary behaviors); and a middle group, which changed one or the other of these behaviors but not both.
Let’s look at those who really seemed to be trying to lose weight. Over 2 years, they got more exercise and improved their diet.
If they succeeded in losing 10% or more of their body weight, they still had a higher risk for cancer than those who had not lost weight — about 30% higher, which is not that different from the 40% increased risk when you include those folks who weren’t changing their lifestyle.
This is why this study is important. The classic teaching is that unintentional weight loss is a bad thing and needs a workup. That’s fine. But we live in a world where perhaps the majority of people are, at any given time, trying to lose weight.
We need to be careful here. I am not by any means trying to say that people who have successfully lost weight have cancer. Both of the following statements can be true:
Significant weight loss, whether intentional or not, is associated with a higher risk for cancer.
Most people with significant weight loss will not have cancer.
Both of these can be true because cancer is, fortunately, rare. Of people who lose weight, the vast majority will lose weight because they are engaging in healthier behaviors. A small number may lose weight because something else is wrong. It’s just hard to tell the two apart.
Out of the nearly 200,000 people in this study, only around 16,000 developed cancer during follow-up. Again, although the chance of having cancer is slightly higher if someone has experienced weight loss, the chance is still very low.
We also need to avoid suggesting that weight loss causes cancer. Some people lose weight because of an existing, as of yet undiagnosed cancer and its metabolic effects. This is borne out if you look at the risk of being diagnosed with cancer as you move further away from the interval of weight loss.
The further you get from the year of that 10% weight loss, the less likely you are to be diagnosed with cancer. Most of these cancers are diagnosed within a year of losing weight. In other words, if you’re reading this and getting worried that you lost weight 10 years ago, you’re probably out of the woods. That was, most likely, just you getting healthier.
Last thing: We have methods for weight loss now that are way more effective than diet or exercise. I’m looking at you, Ozempic. But aside from the weight loss wonder drugs, we have surgery and other interventions. This study did not capture any of that data. Ozempic wasn’t even on the market during this study, so we can’t say anything about the relationship between weight loss and cancer among people using nonlifestyle mechanisms to lose weight.
It’s a complicated system. But the clinically actionable point here is to notice if patients have lost weight. If they’ve lost it without trying, further workup is reasonable. If they’ve lost it but were trying to lose it, tell them “good job.” And consider a workup anyway.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
As anyone who has been through medical training will tell you, some little scenes just stick with you. I had been seeing a patient in our resident clinic in West Philly for a couple of years. She was in her mid-60s with diabetes and hypertension and a distant smoking history. She was overweight and had been trying to improve her diet and lose weight since I started seeing her. One day she came in and was delighted to report that she had finally started shedding some pounds — about 15 in the past 2 months.
I enthusiastically told my preceptor that my careful dietary counseling had finally done the job. She looked through the chart for a moment and asked, “Is she up to date on her cancer screening?” A workup revealed adenocarcinoma of the lung. The patient did well, actually, but the story stuck with me.
The textbooks call it “unintentional weight loss,” often in big, scary letters, and every doctor will go just a bit pale if a patient tells them that, despite efforts not to, they are losing weight. But true unintentional weight loss is not that common. After all, most of us are at least half-heartedly trying to lose weight all the time. Should doctors be worried when we are successful?
A new study suggests that perhaps they should. We’re talking about this study, appearing in JAMA, which combined participants from two long-running observational cohorts: 120,000 women from the Nurses’ Health Study, and 50,000 men from the Health Professionals Follow-Up Study. (These cohorts started in the 1970s and 1980s, so we’ll give them a pass on the gender-specific study designs.)
The rationale of enrolling healthcare providers in these cohort studies is that they would be reliable witnesses of their own health status. If a nurse or doctor says they have pancreatic cancer, it’s likely that they truly have pancreatic cancer. Detailed health surveys were distributed to the participants every other year, and the average follow-up was more than a decade.
Participants recorded their weight — as an aside, a nested study found that self-reported rate was extremely well correlated with professionally measured weight — and whether they had received a cancer diagnosis since the last survey.
This allowed researchers to look at the phenomenon described above. Would weight loss precede a new diagnosis of cancer? And, more interestingly, would intentional weight loss precede a new diagnosis of cancer.
I don’t think it will surprise you to hear that individuals in the highest category of weight loss, those who lost more than 10% of their body weight over a 2-year period, had a larger risk of being diagnosed with cancer in the next year. That’s the yellow line in this graph. In fact, they had about a 40% higher risk than those who did not lose weight.
Increased risk was found across multiple cancer types, though cancers of the gastrointestinal tract, not surprisingly, were most strongly associated with antecedent weight loss.
What about intentionality of weight loss? Unfortunately, the surveys did not ask participants whether they were trying to lose weight. Rather, the surveys asked about exercise and dietary habits. The researchers leveraged these responses to create three categories of participants: those who seemed to be trying to lose weight (defined as people who had increased their exercise and dietary quality); those who didn’t seem to be trying to lose weight (they changed neither exercise nor dietary behaviors); and a middle group, which changed one or the other of these behaviors but not both.
Let’s look at those who really seemed to be trying to lose weight. Over 2 years, they got more exercise and improved their diet.
If they succeeded in losing 10% or more of their body weight, they still had a higher risk for cancer than those who had not lost weight — about 30% higher, which is not that different from the 40% increased risk when you include those folks who weren’t changing their lifestyle.
This is why this study is important. The classic teaching is that unintentional weight loss is a bad thing and needs a workup. That’s fine. But we live in a world where perhaps the majority of people are, at any given time, trying to lose weight.
We need to be careful here. I am not by any means trying to say that people who have successfully lost weight have cancer. Both of the following statements can be true:
Significant weight loss, whether intentional or not, is associated with a higher risk for cancer.
Most people with significant weight loss will not have cancer.
Both of these can be true because cancer is, fortunately, rare. Of people who lose weight, the vast majority will lose weight because they are engaging in healthier behaviors. A small number may lose weight because something else is wrong. It’s just hard to tell the two apart.
Out of the nearly 200,000 people in this study, only around 16,000 developed cancer during follow-up. Again, although the chance of having cancer is slightly higher if someone has experienced weight loss, the chance is still very low.
We also need to avoid suggesting that weight loss causes cancer. Some people lose weight because of an existing, as of yet undiagnosed cancer and its metabolic effects. This is borne out if you look at the risk of being diagnosed with cancer as you move further away from the interval of weight loss.
The further you get from the year of that 10% weight loss, the less likely you are to be diagnosed with cancer. Most of these cancers are diagnosed within a year of losing weight. In other words, if you’re reading this and getting worried that you lost weight 10 years ago, you’re probably out of the woods. That was, most likely, just you getting healthier.
Last thing: We have methods for weight loss now that are way more effective than diet or exercise. I’m looking at you, Ozempic. But aside from the weight loss wonder drugs, we have surgery and other interventions. This study did not capture any of that data. Ozempic wasn’t even on the market during this study, so we can’t say anything about the relationship between weight loss and cancer among people using nonlifestyle mechanisms to lose weight.
It’s a complicated system. But the clinically actionable point here is to notice if patients have lost weight. If they’ve lost it without trying, further workup is reasonable. If they’ve lost it but were trying to lose it, tell them “good job.” And consider a workup anyway.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
As anyone who has been through medical training will tell you, some little scenes just stick with you. I had been seeing a patient in our resident clinic in West Philly for a couple of years. She was in her mid-60s with diabetes and hypertension and a distant smoking history. She was overweight and had been trying to improve her diet and lose weight since I started seeing her. One day she came in and was delighted to report that she had finally started shedding some pounds — about 15 in the past 2 months.
I enthusiastically told my preceptor that my careful dietary counseling had finally done the job. She looked through the chart for a moment and asked, “Is she up to date on her cancer screening?” A workup revealed adenocarcinoma of the lung. The patient did well, actually, but the story stuck with me.
The textbooks call it “unintentional weight loss,” often in big, scary letters, and every doctor will go just a bit pale if a patient tells them that, despite efforts not to, they are losing weight. But true unintentional weight loss is not that common. After all, most of us are at least half-heartedly trying to lose weight all the time. Should doctors be worried when we are successful?
A new study suggests that perhaps they should. We’re talking about this study, appearing in JAMA, which combined participants from two long-running observational cohorts: 120,000 women from the Nurses’ Health Study, and 50,000 men from the Health Professionals Follow-Up Study. (These cohorts started in the 1970s and 1980s, so we’ll give them a pass on the gender-specific study designs.)
The rationale of enrolling healthcare providers in these cohort studies is that they would be reliable witnesses of their own health status. If a nurse or doctor says they have pancreatic cancer, it’s likely that they truly have pancreatic cancer. Detailed health surveys were distributed to the participants every other year, and the average follow-up was more than a decade.
Participants recorded their weight — as an aside, a nested study found that self-reported rate was extremely well correlated with professionally measured weight — and whether they had received a cancer diagnosis since the last survey.
This allowed researchers to look at the phenomenon described above. Would weight loss precede a new diagnosis of cancer? And, more interestingly, would intentional weight loss precede a new diagnosis of cancer.
I don’t think it will surprise you to hear that individuals in the highest category of weight loss, those who lost more than 10% of their body weight over a 2-year period, had a larger risk of being diagnosed with cancer in the next year. That’s the yellow line in this graph. In fact, they had about a 40% higher risk than those who did not lose weight.
Increased risk was found across multiple cancer types, though cancers of the gastrointestinal tract, not surprisingly, were most strongly associated with antecedent weight loss.
What about intentionality of weight loss? Unfortunately, the surveys did not ask participants whether they were trying to lose weight. Rather, the surveys asked about exercise and dietary habits. The researchers leveraged these responses to create three categories of participants: those who seemed to be trying to lose weight (defined as people who had increased their exercise and dietary quality); those who didn’t seem to be trying to lose weight (they changed neither exercise nor dietary behaviors); and a middle group, which changed one or the other of these behaviors but not both.
Let’s look at those who really seemed to be trying to lose weight. Over 2 years, they got more exercise and improved their diet.
If they succeeded in losing 10% or more of their body weight, they still had a higher risk for cancer than those who had not lost weight — about 30% higher, which is not that different from the 40% increased risk when you include those folks who weren’t changing their lifestyle.
This is why this study is important. The classic teaching is that unintentional weight loss is a bad thing and needs a workup. That’s fine. But we live in a world where perhaps the majority of people are, at any given time, trying to lose weight.
We need to be careful here. I am not by any means trying to say that people who have successfully lost weight have cancer. Both of the following statements can be true:
Significant weight loss, whether intentional or not, is associated with a higher risk for cancer.
Most people with significant weight loss will not have cancer.
Both of these can be true because cancer is, fortunately, rare. Of people who lose weight, the vast majority will lose weight because they are engaging in healthier behaviors. A small number may lose weight because something else is wrong. It’s just hard to tell the two apart.
Out of the nearly 200,000 people in this study, only around 16,000 developed cancer during follow-up. Again, although the chance of having cancer is slightly higher if someone has experienced weight loss, the chance is still very low.
We also need to avoid suggesting that weight loss causes cancer. Some people lose weight because of an existing, as of yet undiagnosed cancer and its metabolic effects. This is borne out if you look at the risk of being diagnosed with cancer as you move further away from the interval of weight loss.
The further you get from the year of that 10% weight loss, the less likely you are to be diagnosed with cancer. Most of these cancers are diagnosed within a year of losing weight. In other words, if you’re reading this and getting worried that you lost weight 10 years ago, you’re probably out of the woods. That was, most likely, just you getting healthier.
Last thing: We have methods for weight loss now that are way more effective than diet or exercise. I’m looking at you, Ozempic. But aside from the weight loss wonder drugs, we have surgery and other interventions. This study did not capture any of that data. Ozempic wasn’t even on the market during this study, so we can’t say anything about the relationship between weight loss and cancer among people using nonlifestyle mechanisms to lose weight.
It’s a complicated system. But the clinically actionable point here is to notice if patients have lost weight. If they’ve lost it without trying, further workup is reasonable. If they’ve lost it but were trying to lose it, tell them “good job.” And consider a workup anyway.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Analysis of Nail Excision Practice Patterns in the Medicare Provider Utilization and Payment Database 2012-2017
To the Editor:
Partial or total nail plate excisions commonly are used for the treatment of onychocryptosis and nail spicules. Procedures involving the nail unit require advanced technical skills to achieve optimal functional and aesthetic outcomes, avoid complications, and minimize health care costs. Data on the frequency of nail plate excisions performed by dermatologists and their relative frequency compared to other medical providers are limited. The objective of our study was to analyze trends in nail excision practice patterns among medical providers in the United States.
A retrospective analysis on nail excisions using the Current Procedural Terminology (CPT) code 11750 (excision of nail and nail matrix, partial or complete [eg, ingrown or deformed nail] for permanent removal), which is distinct from code 11755 (biopsy of nail unit [eg, plate, bed, matrix, hyponychium, proximal and lateral nail folds][separate procedure]), was performed using data from the Medicare Provider Utilization and Payment Database 2012-2017.1,2 This file also is used by Peck et al3 in an article submitted to the Journal of the American Podiatric Medical Association and currently under consideration for publication. Procedures were recorded by year and provider type—dermatologist, podiatrist, physician assistant (PA)/nurse practitioner (NP), nondermatologist physician—and subcategorized by provider specialty (Table). Practice locations subcategorized by provider type were mapped using Tableau Software (Salesforce)(Figure). Descriptive statistics including number of providers, mean and median excisions per provider, and minimum/maximum nail excisions were calculated (Table). Practice types of PAs/NPs and specialization of nondermatologist physicians were determined using provider name, identification number, and practice address. This study did not require institutional review board review, as only publicly available data were utilized in our analysis.
A total of 6936 podiatrists, 58 nondermatologist physicians, 25 PAs/NPs, and 4 dermatologists performed 10 or more nail excisions annually under CPT code 11750 from January 2012 to December 2017 with annual means of 31, 31, 25, and 34, respectively (Table). No PAs/NPs included in the dataset worked in dermatology practices during the study period. Physician assistants and NPs most often practiced in podiatry and family medicine (FM) settings (both 40% [10/25]). Nondermatologist physicians most often specialized in FM (40% [23/58])(Table). The greatest number of providers practiced in 3 of the 4 most-populous states: California, Texas, and Florida; the fewest number practiced in 3 of the 10 least-populous states: Alaska, Hawaii, and Vermont. Vermont, Wyoming, and North Dakota—3 of the 5 least-populous states—had the fewest practitioners among the contiguous United States (Figure).
Our study showed that from January 2012 to December 2017, fewer dermatologists performed nail excisions than any other provider type (0.06%, 4 dermatologists of 7023 total providers), and dermatologists performed 1734-fold fewer nail excisions than podiatrists (99%, 6936 podiatrists of 7023 total providers). Only dermatologists practicing in California, Georgia, Indiana, and Oklahoma performed nail excisions. Conversely, podiatrists were more geographically distributed across the United States and other territories, with representation in all 50 states as well as the District of Columbia, Puerto Rico, and Guam.
Reasons for these large discrepancies in practice between dermatologists and other providers likely are multifactorial, encompassing a lack of emphasis on nail procedures in dermatology training, patient perception of the scope of dermatologic practice, and nail excision reimbursement patterns. Most dermatologists likely lack experience in performing nail procedures. The Accreditation Council for Graduate Medical Education requirements mandate that dermatology residents observe or perform 3 nail procedures over 3 years of residency, including 1 that may be performed on a human cadaver.4 In contrast, podiatry trainees must gain competency in toenail avulsion (both partial and complete), participate in anesthesia workshops, and become proficient in administering lower extremity blocks by the end of their training.5 Therefore, incorporating aspects of podiatric surgical training into dermatology residency requirements may increase the competency and comfort of dermatologists in performing nail excisions and practicing as nail experts as attending physicians.
It is likely that US patients do not perceive dermatologists as nail specialists and instead primarily consult podiatrists or FM and/or internal medicine physicians for treatment; for example, nail disease was one of the least common reasons for consulting a dermatologist (5%) in a German nationwide survey-based study (N=1015).6 Therefore, increased efforts are needed to educate the general public about the expertise of dermatologists in the diagnosis and management of nail conditions.
Reimbursement also may be a barrier to dermatologists performing nail procedures as part of their scope of practice; for example, in a retrospective study of nail biopsies using the Medicare Provider Utilization and Payment Database, there was no statistically significant difference in reimbursements for nail biopsies vs skin biopsies from 2012 to 2017 (P=0.69).7 Similar to nail biopsies, nail excisions typically are much more time consuming and technically demanding than skin biopsies, which may discourage dermatologists from routinely performing nail excision procedures.
Our study is subject to a number of limitations. The data reflected only US-based practice patterns and may not be applicable to nail procedures globally. There also is the potential for miscoding of procedures in the Medicare database. The data included only Part B Medicare fee-for-service and excludes non-Medicare insured, uninsured, and self-pay patients, as well as aggregated records from 10 or fewer Medicare beneficiaries.
Dermatologists rarely perform nail excisions and perform fewer nail excisions than any other provider type in the United States. There currently is an unmet need for comprehensive nail surgery education in US-based dermatology residency programs. We hope that our study fosters interdisciplinary collegiality and training between podiatrists and dermatologists and promotes expanded access to care across the United States to serve patients with nail disorders.
- Centers for Medicare & Medicaid Services. Medicare Fee-For-Service Provider Utilization & Payment Data Physician and Other Supplier Public Use File: A Methodological Overview . Updated September 22, 2020. Accessed January 5, 2024. https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/medicare-provider-charge-data/downloads/medicare-physician-and-other-supplier-puf-methodology.pdf
- Centers for Medicare and Medicaid Services. Billing and Coding: Surgical Treatment of Nails. Updated November 9, 2023. Accessed January 8, 2024. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleID=52998#:~:text=The%20description%20of%20CPT%20codes,date%20of%20service%20(DOS).
- Peck GM, Vlahovic TC, Hill R, et al. Senior podiatrists in solo practice are high performers of nail excisions. JAPMA. In press.
- Accreditation Council for Graduate Medical Education. Case log minimums. review committee for dermatology. Published May 2019. Accessed January 5, 2024. https://www.acgme.org/Portals/0/PFAssets/ProgramResources/CaseLogMinimums.pdf?ver=2018-04-03-102751-650
- Council on Podiatric Medical Education. Standards and Requirements for Approval of Podiatric Medicine and Surgery Residencies. Published July 2023. Accessed January 17, 2024. https://www.cpme.org/files/320%20Council%20Approved%20October%202022%20-%20April%202023%20edits.pdf
- Augustin M, Eissing L, Elsner P, et al. Perception and image of dermatology in the German general population 2002-2014. J Eur Acad Dermatol Venereol. 2017;31:2124-2130.
- Wang Y, Lipner SR. Retrospective analysis of nail biopsies performed using the Medicare provider utilization and payment database 2012 to 2017. Dermatol Ther. 2021;34:E14928.
To the Editor:
Partial or total nail plate excisions commonly are used for the treatment of onychocryptosis and nail spicules. Procedures involving the nail unit require advanced technical skills to achieve optimal functional and aesthetic outcomes, avoid complications, and minimize health care costs. Data on the frequency of nail plate excisions performed by dermatologists and their relative frequency compared to other medical providers are limited. The objective of our study was to analyze trends in nail excision practice patterns among medical providers in the United States.
A retrospective analysis on nail excisions using the Current Procedural Terminology (CPT) code 11750 (excision of nail and nail matrix, partial or complete [eg, ingrown or deformed nail] for permanent removal), which is distinct from code 11755 (biopsy of nail unit [eg, plate, bed, matrix, hyponychium, proximal and lateral nail folds][separate procedure]), was performed using data from the Medicare Provider Utilization and Payment Database 2012-2017.1,2 This file also is used by Peck et al3 in an article submitted to the Journal of the American Podiatric Medical Association and currently under consideration for publication. Procedures were recorded by year and provider type—dermatologist, podiatrist, physician assistant (PA)/nurse practitioner (NP), nondermatologist physician—and subcategorized by provider specialty (Table). Practice locations subcategorized by provider type were mapped using Tableau Software (Salesforce)(Figure). Descriptive statistics including number of providers, mean and median excisions per provider, and minimum/maximum nail excisions were calculated (Table). Practice types of PAs/NPs and specialization of nondermatologist physicians were determined using provider name, identification number, and practice address. This study did not require institutional review board review, as only publicly available data were utilized in our analysis.
A total of 6936 podiatrists, 58 nondermatologist physicians, 25 PAs/NPs, and 4 dermatologists performed 10 or more nail excisions annually under CPT code 11750 from January 2012 to December 2017 with annual means of 31, 31, 25, and 34, respectively (Table). No PAs/NPs included in the dataset worked in dermatology practices during the study period. Physician assistants and NPs most often practiced in podiatry and family medicine (FM) settings (both 40% [10/25]). Nondermatologist physicians most often specialized in FM (40% [23/58])(Table). The greatest number of providers practiced in 3 of the 4 most-populous states: California, Texas, and Florida; the fewest number practiced in 3 of the 10 least-populous states: Alaska, Hawaii, and Vermont. Vermont, Wyoming, and North Dakota—3 of the 5 least-populous states—had the fewest practitioners among the contiguous United States (Figure).
Our study showed that from January 2012 to December 2017, fewer dermatologists performed nail excisions than any other provider type (0.06%, 4 dermatologists of 7023 total providers), and dermatologists performed 1734-fold fewer nail excisions than podiatrists (99%, 6936 podiatrists of 7023 total providers). Only dermatologists practicing in California, Georgia, Indiana, and Oklahoma performed nail excisions. Conversely, podiatrists were more geographically distributed across the United States and other territories, with representation in all 50 states as well as the District of Columbia, Puerto Rico, and Guam.
Reasons for these large discrepancies in practice between dermatologists and other providers likely are multifactorial, encompassing a lack of emphasis on nail procedures in dermatology training, patient perception of the scope of dermatologic practice, and nail excision reimbursement patterns. Most dermatologists likely lack experience in performing nail procedures. The Accreditation Council for Graduate Medical Education requirements mandate that dermatology residents observe or perform 3 nail procedures over 3 years of residency, including 1 that may be performed on a human cadaver.4 In contrast, podiatry trainees must gain competency in toenail avulsion (both partial and complete), participate in anesthesia workshops, and become proficient in administering lower extremity blocks by the end of their training.5 Therefore, incorporating aspects of podiatric surgical training into dermatology residency requirements may increase the competency and comfort of dermatologists in performing nail excisions and practicing as nail experts as attending physicians.
It is likely that US patients do not perceive dermatologists as nail specialists and instead primarily consult podiatrists or FM and/or internal medicine physicians for treatment; for example, nail disease was one of the least common reasons for consulting a dermatologist (5%) in a German nationwide survey-based study (N=1015).6 Therefore, increased efforts are needed to educate the general public about the expertise of dermatologists in the diagnosis and management of nail conditions.
Reimbursement also may be a barrier to dermatologists performing nail procedures as part of their scope of practice; for example, in a retrospective study of nail biopsies using the Medicare Provider Utilization and Payment Database, there was no statistically significant difference in reimbursements for nail biopsies vs skin biopsies from 2012 to 2017 (P=0.69).7 Similar to nail biopsies, nail excisions typically are much more time consuming and technically demanding than skin biopsies, which may discourage dermatologists from routinely performing nail excision procedures.
Our study is subject to a number of limitations. The data reflected only US-based practice patterns and may not be applicable to nail procedures globally. There also is the potential for miscoding of procedures in the Medicare database. The data included only Part B Medicare fee-for-service and excludes non-Medicare insured, uninsured, and self-pay patients, as well as aggregated records from 10 or fewer Medicare beneficiaries.
Dermatologists rarely perform nail excisions and perform fewer nail excisions than any other provider type in the United States. There currently is an unmet need for comprehensive nail surgery education in US-based dermatology residency programs. We hope that our study fosters interdisciplinary collegiality and training between podiatrists and dermatologists and promotes expanded access to care across the United States to serve patients with nail disorders.
To the Editor:
Partial or total nail plate excisions commonly are used for the treatment of onychocryptosis and nail spicules. Procedures involving the nail unit require advanced technical skills to achieve optimal functional and aesthetic outcomes, avoid complications, and minimize health care costs. Data on the frequency of nail plate excisions performed by dermatologists and their relative frequency compared to other medical providers are limited. The objective of our study was to analyze trends in nail excision practice patterns among medical providers in the United States.
A retrospective analysis on nail excisions using the Current Procedural Terminology (CPT) code 11750 (excision of nail and nail matrix, partial or complete [eg, ingrown or deformed nail] for permanent removal), which is distinct from code 11755 (biopsy of nail unit [eg, plate, bed, matrix, hyponychium, proximal and lateral nail folds][separate procedure]), was performed using data from the Medicare Provider Utilization and Payment Database 2012-2017.1,2 This file also is used by Peck et al3 in an article submitted to the Journal of the American Podiatric Medical Association and currently under consideration for publication. Procedures were recorded by year and provider type—dermatologist, podiatrist, physician assistant (PA)/nurse practitioner (NP), nondermatologist physician—and subcategorized by provider specialty (Table). Practice locations subcategorized by provider type were mapped using Tableau Software (Salesforce)(Figure). Descriptive statistics including number of providers, mean and median excisions per provider, and minimum/maximum nail excisions were calculated (Table). Practice types of PAs/NPs and specialization of nondermatologist physicians were determined using provider name, identification number, and practice address. This study did not require institutional review board review, as only publicly available data were utilized in our analysis.
A total of 6936 podiatrists, 58 nondermatologist physicians, 25 PAs/NPs, and 4 dermatologists performed 10 or more nail excisions annually under CPT code 11750 from January 2012 to December 2017 with annual means of 31, 31, 25, and 34, respectively (Table). No PAs/NPs included in the dataset worked in dermatology practices during the study period. Physician assistants and NPs most often practiced in podiatry and family medicine (FM) settings (both 40% [10/25]). Nondermatologist physicians most often specialized in FM (40% [23/58])(Table). The greatest number of providers practiced in 3 of the 4 most-populous states: California, Texas, and Florida; the fewest number practiced in 3 of the 10 least-populous states: Alaska, Hawaii, and Vermont. Vermont, Wyoming, and North Dakota—3 of the 5 least-populous states—had the fewest practitioners among the contiguous United States (Figure).
Our study showed that from January 2012 to December 2017, fewer dermatologists performed nail excisions than any other provider type (0.06%, 4 dermatologists of 7023 total providers), and dermatologists performed 1734-fold fewer nail excisions than podiatrists (99%, 6936 podiatrists of 7023 total providers). Only dermatologists practicing in California, Georgia, Indiana, and Oklahoma performed nail excisions. Conversely, podiatrists were more geographically distributed across the United States and other territories, with representation in all 50 states as well as the District of Columbia, Puerto Rico, and Guam.
Reasons for these large discrepancies in practice between dermatologists and other providers likely are multifactorial, encompassing a lack of emphasis on nail procedures in dermatology training, patient perception of the scope of dermatologic practice, and nail excision reimbursement patterns. Most dermatologists likely lack experience in performing nail procedures. The Accreditation Council for Graduate Medical Education requirements mandate that dermatology residents observe or perform 3 nail procedures over 3 years of residency, including 1 that may be performed on a human cadaver.4 In contrast, podiatry trainees must gain competency in toenail avulsion (both partial and complete), participate in anesthesia workshops, and become proficient in administering lower extremity blocks by the end of their training.5 Therefore, incorporating aspects of podiatric surgical training into dermatology residency requirements may increase the competency and comfort of dermatologists in performing nail excisions and practicing as nail experts as attending physicians.
It is likely that US patients do not perceive dermatologists as nail specialists and instead primarily consult podiatrists or FM and/or internal medicine physicians for treatment; for example, nail disease was one of the least common reasons for consulting a dermatologist (5%) in a German nationwide survey-based study (N=1015).6 Therefore, increased efforts are needed to educate the general public about the expertise of dermatologists in the diagnosis and management of nail conditions.
Reimbursement also may be a barrier to dermatologists performing nail procedures as part of their scope of practice; for example, in a retrospective study of nail biopsies using the Medicare Provider Utilization and Payment Database, there was no statistically significant difference in reimbursements for nail biopsies vs skin biopsies from 2012 to 2017 (P=0.69).7 Similar to nail biopsies, nail excisions typically are much more time consuming and technically demanding than skin biopsies, which may discourage dermatologists from routinely performing nail excision procedures.
Our study is subject to a number of limitations. The data reflected only US-based practice patterns and may not be applicable to nail procedures globally. There also is the potential for miscoding of procedures in the Medicare database. The data included only Part B Medicare fee-for-service and excludes non-Medicare insured, uninsured, and self-pay patients, as well as aggregated records from 10 or fewer Medicare beneficiaries.
Dermatologists rarely perform nail excisions and perform fewer nail excisions than any other provider type in the United States. There currently is an unmet need for comprehensive nail surgery education in US-based dermatology residency programs. We hope that our study fosters interdisciplinary collegiality and training between podiatrists and dermatologists and promotes expanded access to care across the United States to serve patients with nail disorders.
- Centers for Medicare & Medicaid Services. Medicare Fee-For-Service Provider Utilization & Payment Data Physician and Other Supplier Public Use File: A Methodological Overview . Updated September 22, 2020. Accessed January 5, 2024. https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/medicare-provider-charge-data/downloads/medicare-physician-and-other-supplier-puf-methodology.pdf
- Centers for Medicare and Medicaid Services. Billing and Coding: Surgical Treatment of Nails. Updated November 9, 2023. Accessed January 8, 2024. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleID=52998#:~:text=The%20description%20of%20CPT%20codes,date%20of%20service%20(DOS).
- Peck GM, Vlahovic TC, Hill R, et al. Senior podiatrists in solo practice are high performers of nail excisions. JAPMA. In press.
- Accreditation Council for Graduate Medical Education. Case log minimums. review committee for dermatology. Published May 2019. Accessed January 5, 2024. https://www.acgme.org/Portals/0/PFAssets/ProgramResources/CaseLogMinimums.pdf?ver=2018-04-03-102751-650
- Council on Podiatric Medical Education. Standards and Requirements for Approval of Podiatric Medicine and Surgery Residencies. Published July 2023. Accessed January 17, 2024. https://www.cpme.org/files/320%20Council%20Approved%20October%202022%20-%20April%202023%20edits.pdf
- Augustin M, Eissing L, Elsner P, et al. Perception and image of dermatology in the German general population 2002-2014. J Eur Acad Dermatol Venereol. 2017;31:2124-2130.
- Wang Y, Lipner SR. Retrospective analysis of nail biopsies performed using the Medicare provider utilization and payment database 2012 to 2017. Dermatol Ther. 2021;34:E14928.
- Centers for Medicare & Medicaid Services. Medicare Fee-For-Service Provider Utilization & Payment Data Physician and Other Supplier Public Use File: A Methodological Overview . Updated September 22, 2020. Accessed January 5, 2024. https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/medicare-provider-charge-data/downloads/medicare-physician-and-other-supplier-puf-methodology.pdf
- Centers for Medicare and Medicaid Services. Billing and Coding: Surgical Treatment of Nails. Updated November 9, 2023. Accessed January 8, 2024. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleID=52998#:~:text=The%20description%20of%20CPT%20codes,date%20of%20service%20(DOS).
- Peck GM, Vlahovic TC, Hill R, et al. Senior podiatrists in solo practice are high performers of nail excisions. JAPMA. In press.
- Accreditation Council for Graduate Medical Education. Case log minimums. review committee for dermatology. Published May 2019. Accessed January 5, 2024. https://www.acgme.org/Portals/0/PFAssets/ProgramResources/CaseLogMinimums.pdf?ver=2018-04-03-102751-650
- Council on Podiatric Medical Education. Standards and Requirements for Approval of Podiatric Medicine and Surgery Residencies. Published July 2023. Accessed January 17, 2024. https://www.cpme.org/files/320%20Council%20Approved%20October%202022%20-%20April%202023%20edits.pdf
- Augustin M, Eissing L, Elsner P, et al. Perception and image of dermatology in the German general population 2002-2014. J Eur Acad Dermatol Venereol. 2017;31:2124-2130.
- Wang Y, Lipner SR. Retrospective analysis of nail biopsies performed using the Medicare provider utilization and payment database 2012 to 2017. Dermatol Ther. 2021;34:E14928.
Practice Points
- Dermatologists are considered nail experts but perform nail excisions less frequently than their podiatric counterparts and physicians in other specialties.
- Aspects of podiatric surgical training should be incorporated into dermatology residency to increase competency and comfort of dermatologists in nail excision procedures.
- Dermatologists may not be perceived as nail experts by the public, indicating a need for increased community education on the role of dermatologists in treating nail disease.