Dermatology

The Food and Drug Administration draft guidance released recently on possible contamination of tattoo ink was not concerning Whitney Donohue, 34, owner of Forget Me Not Tattoo in Billings, Mont. 

“I get our ink directly through the manufacturer – not at a store or through Amazon or eBay,” she said. “You never know if it’s going to be repackaged.”

Tattoo artists themselves, she said, regulate the quality of ink they use. 

Still, the threat is real, said Bruce Brod, MD, a clinical professor of dermatology at the University of Pennsylvania Health System. “I’ve seen several different infections from tattooing, and they are from organisms that tend to contaminate things in damp, liquid-type environments.”

The FDA released the new draft guidance aiming to reduce the use of pathogen-contaminated tattoo ink, which can cause stubborn infections that are especially hard to treat, dermatologists said.

“Tattooing involves puncturing the epidermis about 100 times per second with needles and depositing ink 1.5 to 2 millimeters below the surface of the skin, deep into the dermis,” the guidance states. “Contaminated tattoo ink can cause infections and serious injuries. Because these inks are injected, pathogens or other harmful substances in these inks can travel from the injection site through the blood and lymphatic systems to other parts of the body.”

The guidance comes as body art continues to get more popular. According to a 2019 poll, 30% of Americans had at least one tattoo – up from 21% in 2012. Forty percent of people 18-34 and 36% of those ages 35-54 had at least one tattoo. And though they are commonplace, tattoos come with medical risks that should be known beforehand, doctors said. 

Commonly reported symptoms of tattoo ink–associated infections include rashes, blisters, painful nodules, and severe abscesses. One of the most common bacteria found in contaminated tattoo ink is nontuberculous mycobacteria, which is related to the bacteria that causes tuberculosis and can be found in soil and water.

The guidance lists several unsanitary manufacturing conditions that may lead to ink contamination, including: 

• Preparing or packing of tattoo inks in facilities that are hard to sanitize, such as carpeted areas
• Ink or ink components left uncovered, especially near open air ducts
• Unsanitary mixing of tattoo inks, including with unclean utensils or containers
• Lack of appropriate attire by staff, failure to use hairnets, lab coats, aprons, gowns, masks, or gloves

“Infections will often spread along the drainage channels in the skin and create squiggly, uneven lines of big red, lumpy nodules,” Dr. Brod said. 

Between 2003 and 2023, there were 18 recalls of tattoo inks that were contaminated with various microorganisms, according to the FDA. In May 2019, the FDA issued a safety alert advising consumers, tattoo artists, and retailers to avoid using or selling certain tattoo inks contaminated with microorganisms.

Reputable ink manufacturers use a process called gamma radiation, which refers to electromagnetic radiation of high frequencies to kill microorganisms in the ink and its packaging.

Most of the trustworthy, high-quality ink manufacturers are well-known among tattoo artists, Ms. Donohue said. 

While she has seen customers with sensitive skin have allergic reactions, she has not seen someone come back with an infection in her 9 years working in the tattoo industry.

Because tattoo ink is considered a cosmetic product, there is not much regulatory oversight involved, which means the sterility and quality of ingredients vary, said Teo Soleymani, MD, an assistant clinical professor of dermatology and dermatological surgery at the UCLA David Geffen School of Medicine.

“Cosmeceuticals aren’t regulated by the FDA like prescription medication,” he said. “What we’ve seen many times is inadvertent contamination during the application process or contamination while the inks are being made.”

In years past, unclean needles spreading hepatitis and HIV were more of a concern, but those rates have dropped significantly, Dr. Soleymani said. 

The infections that have increased are from rare bacteria that exist in stagnant water. And they are injected into a part of the body that allows them to evade the immune system, he said: shallow enough that there aren’t many associated blood vessels, but not still below the layer of skin that gets sloughed off every 28 days. 

Sometimes, antibiotics alone won’t cut it, and the tattoo will require surgical removal. 

“The aesthetic you were going for has to be not only removed, but you’re left with a surgical scar,” Dr. Soleymani said. “Tattoos can be beautiful, but they can come with unwanted visitors that can cause months of misery.”

A version of this article first appeared on WebMD.com.

The Food and Drug Administration draft guidance released recently on possible contamination of tattoo ink was not concerning Whitney Donohue, 34, owner of Forget Me Not Tattoo in Billings, Mont. 

“I get our ink directly through the manufacturer – not at a store or through Amazon or eBay,” she said. “You never know if it’s going to be repackaged.”

Tattoo artists themselves, she said, regulate the quality of ink they use. 

Still, the threat is real, said Bruce Brod, MD, a clinical professor of dermatology at the University of Pennsylvania Health System. “I’ve seen several different infections from tattooing, and they are from organisms that tend to contaminate things in damp, liquid-type environments.”

The FDA released the new draft guidance aiming to reduce the use of pathogen-contaminated tattoo ink, which can cause stubborn infections that are especially hard to treat, dermatologists said.

“Tattooing involves puncturing the epidermis about 100 times per second with needles and depositing ink 1.5 to 2 millimeters below the surface of the skin, deep into the dermis,” the guidance states. “Contaminated tattoo ink can cause infections and serious injuries. Because these inks are injected, pathogens or other harmful substances in these inks can travel from the injection site through the blood and lymphatic systems to other parts of the body.”

The guidance comes as body art continues to get more popular. According to a 2019 poll, 30% of Americans had at least one tattoo – up from 21% in 2012. Forty percent of people 18-34 and 36% of those ages 35-54 had at least one tattoo. And though they are commonplace, tattoos come with medical risks that should be known beforehand, doctors said. 

Commonly reported symptoms of tattoo ink–associated infections include rashes, blisters, painful nodules, and severe abscesses. One of the most common bacteria found in contaminated tattoo ink is nontuberculous mycobacteria, which is related to the bacteria that causes tuberculosis and can be found in soil and water.

The guidance lists several unsanitary manufacturing conditions that may lead to ink contamination, including: 

• Preparing or packing of tattoo inks in facilities that are hard to sanitize, such as carpeted areas
• Ink or ink components left uncovered, especially near open air ducts
• Unsanitary mixing of tattoo inks, including with unclean utensils or containers
• Lack of appropriate attire by staff, failure to use hairnets, lab coats, aprons, gowns, masks, or gloves

“Infections will often spread along the drainage channels in the skin and create squiggly, uneven lines of big red, lumpy nodules,” Dr. Brod said. 

Between 2003 and 2023, there were 18 recalls of tattoo inks that were contaminated with various microorganisms, according to the FDA. In May 2019, the FDA issued a safety alert advising consumers, tattoo artists, and retailers to avoid using or selling certain tattoo inks contaminated with microorganisms.

Reputable ink manufacturers use a process called gamma radiation, which refers to electromagnetic radiation of high frequencies to kill microorganisms in the ink and its packaging.

Most of the trustworthy, high-quality ink manufacturers are well-known among tattoo artists, Ms. Donohue said. 

While she has seen customers with sensitive skin have allergic reactions, she has not seen someone come back with an infection in her 9 years working in the tattoo industry.

Because tattoo ink is considered a cosmetic product, there is not much regulatory oversight involved, which means the sterility and quality of ingredients vary, said Teo Soleymani, MD, an assistant clinical professor of dermatology and dermatological surgery at the UCLA David Geffen School of Medicine.

“Cosmeceuticals aren’t regulated by the FDA like prescription medication,” he said. “What we’ve seen many times is inadvertent contamination during the application process or contamination while the inks are being made.”

In years past, unclean needles spreading hepatitis and HIV were more of a concern, but those rates have dropped significantly, Dr. Soleymani said. 

The infections that have increased are from rare bacteria that exist in stagnant water. And they are injected into a part of the body that allows them to evade the immune system, he said: shallow enough that there aren’t many associated blood vessels, but not still below the layer of skin that gets sloughed off every 28 days. 

Sometimes, antibiotics alone won’t cut it, and the tattoo will require surgical removal. 

“The aesthetic you were going for has to be not only removed, but you’re left with a surgical scar,” Dr. Soleymani said. “Tattoos can be beautiful, but they can come with unwanted visitors that can cause months of misery.”

A version of this article first appeared on WebMD.com.

The Food and Drug Administration draft guidance released recently on possible contamination of tattoo ink was not concerning Whitney Donohue, 34, owner of Forget Me Not Tattoo in Billings, Mont. 

“I get our ink directly through the manufacturer – not at a store or through Amazon or eBay,” she said. “You never know if it’s going to be repackaged.”

Tattoo artists themselves, she said, regulate the quality of ink they use. 

Still, the threat is real, said Bruce Brod, MD, a clinical professor of dermatology at the University of Pennsylvania Health System. “I’ve seen several different infections from tattooing, and they are from organisms that tend to contaminate things in damp, liquid-type environments.”

The FDA released the new draft guidance aiming to reduce the use of pathogen-contaminated tattoo ink, which can cause stubborn infections that are especially hard to treat, dermatologists said.

“Tattooing involves puncturing the epidermis about 100 times per second with needles and depositing ink 1.5 to 2 millimeters below the surface of the skin, deep into the dermis,” the guidance states. “Contaminated tattoo ink can cause infections and serious injuries. Because these inks are injected, pathogens or other harmful substances in these inks can travel from the injection site through the blood and lymphatic systems to other parts of the body.”

The guidance comes as body art continues to get more popular. According to a 2019 poll, 30% of Americans had at least one tattoo – up from 21% in 2012. Forty percent of people 18-34 and 36% of those ages 35-54 had at least one tattoo. And though they are commonplace, tattoos come with medical risks that should be known beforehand, doctors said. 

Commonly reported symptoms of tattoo ink–associated infections include rashes, blisters, painful nodules, and severe abscesses. One of the most common bacteria found in contaminated tattoo ink is nontuberculous mycobacteria, which is related to the bacteria that causes tuberculosis and can be found in soil and water.

The guidance lists several unsanitary manufacturing conditions that may lead to ink contamination, including: 

• Preparing or packing of tattoo inks in facilities that are hard to sanitize, such as carpeted areas
• Ink or ink components left uncovered, especially near open air ducts
• Unsanitary mixing of tattoo inks, including with unclean utensils or containers
• Lack of appropriate attire by staff, failure to use hairnets, lab coats, aprons, gowns, masks, or gloves

“Infections will often spread along the drainage channels in the skin and create squiggly, uneven lines of big red, lumpy nodules,” Dr. Brod said. 

Between 2003 and 2023, there were 18 recalls of tattoo inks that were contaminated with various microorganisms, according to the FDA. In May 2019, the FDA issued a safety alert advising consumers, tattoo artists, and retailers to avoid using or selling certain tattoo inks contaminated with microorganisms.

Reputable ink manufacturers use a process called gamma radiation, which refers to electromagnetic radiation of high frequencies to kill microorganisms in the ink and its packaging.

Most of the trustworthy, high-quality ink manufacturers are well-known among tattoo artists, Ms. Donohue said. 

While she has seen customers with sensitive skin have allergic reactions, she has not seen someone come back with an infection in her 9 years working in the tattoo industry.

Because tattoo ink is considered a cosmetic product, there is not much regulatory oversight involved, which means the sterility and quality of ingredients vary, said Teo Soleymani, MD, an assistant clinical professor of dermatology and dermatological surgery at the UCLA David Geffen School of Medicine.

“Cosmeceuticals aren’t regulated by the FDA like prescription medication,” he said. “What we’ve seen many times is inadvertent contamination during the application process or contamination while the inks are being made.”

In years past, unclean needles spreading hepatitis and HIV were more of a concern, but those rates have dropped significantly, Dr. Soleymani said. 

The infections that have increased are from rare bacteria that exist in stagnant water. And they are injected into a part of the body that allows them to evade the immune system, he said: shallow enough that there aren’t many associated blood vessels, but not still below the layer of skin that gets sloughed off every 28 days. 

Sometimes, antibiotics alone won’t cut it, and the tattoo will require surgical removal. 

“The aesthetic you were going for has to be not only removed, but you’re left with a surgical scar,” Dr. Soleymani said. “Tattoos can be beautiful, but they can come with unwanted visitors that can cause months of misery.”

A version of this article first appeared on WebMD.com.

Adalimumab, sold under the brand name Humira, enjoyed a long run as one of the world’s best-selling medicines. But its 20-year, competition-free period has ended, and despite its best efforts to delay their arrival, drug manufacturer AbbVie now faces increasing competition from biosimilars entering the marketplace.
 

But one biosimilar about to be launched may be something of a game changer. Coherus BioSciences has announced plans to market its biosimilar Yusimry (adalimumab-aqvh) at a cost of $995 for two autoinjectors. This represents an approximate 85% discount over Humira’s sale list price of $6922.

This price, however, is slated to plunge even further as Coherus has also revealed that it will work with the Mark Cuban Cost Plus Drug Company (MCCPDC) to offer an even lower price. When Yusimry launches in July, it will sell for about $579 for two autoinjectors, making it the lowest-priced adalimumab biosimilar on the market.

“Coherus and Cost Plus Drug Company share a common mission, to increase access to high-quality medicine for patients at an affordable price,” said Dennis Lanfear, MBA, president, CEO and chairman of Coherus. “Mark Cuban and his team offer innovative solutions to health care problems, and Coherus is also a highly innovative company focused on unmet patient needs.”

He noted that, with adalimumab biosimilar pricing, this translates to a low list price approach. “We are pleased that Yusimry will be a part of that, as the first biologic they carry,” Mr. Lanfear said.

MCCPDC prices are based on the cost of ingredients and manufacturing plus 15% margin, a $3 pharmacy dispensing fee, and a $5 shipping fee. The company has expanded its inventory from 100 generics to more than 350 medications since it launched in January 2022. While MCCPDC is primarily directed to people who are paying cash for drugs, it does take insurance from select plans. And even for people who are covered by other insurers, the cost of drugs from Mr. Cuban’s company may be less than their out-of-pocket costs if they did go through their payer.

The low pricing of Yusimry is welcome, said Marcus Snow, MD, an assistant professor in the division of rheumatology at the University of Nebraska Medical Center, Omaha, but he pointed out that it is still a very expensive drug. “For patients who can’t afford Humira due to poor insurance coverage and high out-of-pocket costs, it is a welcome option. But it’s also unclear how many patients who lack adequate health insurance coverage can afford to pay $579 a month out of their own pockets.”
 

The biosimilars are coming

By early December 2022, the Food and Drug Administration had approved seven Humira biosimilars, and Amgen launched the first biosimilar to come on the market, Amjevita, soon afterward. By July 2023, half a dozen more are expected to enter the marketplace, said Steven Horvitz, managing director of EMC Analytics Group, a pharmaceutical research firm.

Mr. Horvitz agrees that the system is out of control, but it is unclear how much of an effect the low price tag on the Coherus product will have. “Some insurers may say, ‘we want the lowest price, and we don’t care about rebates,’ and will go with it,” he said. “PBMs [pharmacy benefit managers] are all about economics, so we have to see how many of their major clients will ask for the lowest price.”

Amgen has more or less followed the status quo on pricing for its biosimilar, but with a twist. It›s being offered at two different prices: $85,494 a year, which is only a 5% discount from Humira’s list price, or at $40,497 a year, a 55% discount. However, to date, the lower price has generally not been granted favorable formulary placement by PBMs. The plans that adopt the higher-priced biosimilar will get bigger rebates, but patients with coinsurance and deductibles will pay more out of pocket.

It is yet unknown how the pricing on Yusimry will affect the biosimilars ready to launch. “Will it give them pause for thought or not make any difference?” Mr. Horvitz said. “The companies do not reveal their pricing before the fact, so we have to wait and see.”

Large PBMs have not jumped at the opportunity to offer the Coherus biosimilar, but SmithRx, which bills itself as “next-generation pharmacy benefits management,” announced that it will offer Yusimry to its members at a discount of more than 90%.

“Unlike traditional PBMs, SmithRx prioritizes transparency and up-front cost savings. Humira is often an employer’s top drug expense so offering a low-cost alternative will have significant impact,” Jake Frenz, CEO and founder of SmithRx, said in a statement. “We’re excited to work with Cost Plus Drugs to bring this biosimilar to our members – and significantly reduce costs for them and their employers.”

A version of this article first appeared on Medscape.com.

Adalimumab, sold under the brand name Humira, enjoyed a long run as one of the world’s best-selling medicines. But its 20-year, competition-free period has ended, and despite its best efforts to delay their arrival, drug manufacturer AbbVie now faces increasing competition from biosimilars entering the marketplace.
 

But one biosimilar about to be launched may be something of a game changer. Coherus BioSciences has announced plans to market its biosimilar Yusimry (adalimumab-aqvh) at a cost of $995 for two autoinjectors. This represents an approximate 85% discount over Humira’s sale list price of $6922.

This price, however, is slated to plunge even further as Coherus has also revealed that it will work with the Mark Cuban Cost Plus Drug Company (MCCPDC) to offer an even lower price. When Yusimry launches in July, it will sell for about $579 for two autoinjectors, making it the lowest-priced adalimumab biosimilar on the market.

“Coherus and Cost Plus Drug Company share a common mission, to increase access to high-quality medicine for patients at an affordable price,” said Dennis Lanfear, MBA, president, CEO and chairman of Coherus. “Mark Cuban and his team offer innovative solutions to health care problems, and Coherus is also a highly innovative company focused on unmet patient needs.”

He noted that, with adalimumab biosimilar pricing, this translates to a low list price approach. “We are pleased that Yusimry will be a part of that, as the first biologic they carry,” Mr. Lanfear said.

MCCPDC prices are based on the cost of ingredients and manufacturing plus 15% margin, a $3 pharmacy dispensing fee, and a $5 shipping fee. The company has expanded its inventory from 100 generics to more than 350 medications since it launched in January 2022. While MCCPDC is primarily directed to people who are paying cash for drugs, it does take insurance from select plans. And even for people who are covered by other insurers, the cost of drugs from Mr. Cuban’s company may be less than their out-of-pocket costs if they did go through their payer.

The low pricing of Yusimry is welcome, said Marcus Snow, MD, an assistant professor in the division of rheumatology at the University of Nebraska Medical Center, Omaha, but he pointed out that it is still a very expensive drug. “For patients who can’t afford Humira due to poor insurance coverage and high out-of-pocket costs, it is a welcome option. But it’s also unclear how many patients who lack adequate health insurance coverage can afford to pay $579 a month out of their own pockets.”
 

The biosimilars are coming

By early December 2022, the Food and Drug Administration had approved seven Humira biosimilars, and Amgen launched the first biosimilar to come on the market, Amjevita, soon afterward. By July 2023, half a dozen more are expected to enter the marketplace, said Steven Horvitz, managing director of EMC Analytics Group, a pharmaceutical research firm.

Mr. Horvitz agrees that the system is out of control, but it is unclear how much of an effect the low price tag on the Coherus product will have. “Some insurers may say, ‘we want the lowest price, and we don’t care about rebates,’ and will go with it,” he said. “PBMs [pharmacy benefit managers] are all about economics, so we have to see how many of their major clients will ask for the lowest price.”

Amgen has more or less followed the status quo on pricing for its biosimilar, but with a twist. It›s being offered at two different prices: $85,494 a year, which is only a 5% discount from Humira’s list price, or at $40,497 a year, a 55% discount. However, to date, the lower price has generally not been granted favorable formulary placement by PBMs. The plans that adopt the higher-priced biosimilar will get bigger rebates, but patients with coinsurance and deductibles will pay more out of pocket.

It is yet unknown how the pricing on Yusimry will affect the biosimilars ready to launch. “Will it give them pause for thought or not make any difference?” Mr. Horvitz said. “The companies do not reveal their pricing before the fact, so we have to wait and see.”

Large PBMs have not jumped at the opportunity to offer the Coherus biosimilar, but SmithRx, which bills itself as “next-generation pharmacy benefits management,” announced that it will offer Yusimry to its members at a discount of more than 90%.

“Unlike traditional PBMs, SmithRx prioritizes transparency and up-front cost savings. Humira is often an employer’s top drug expense so offering a low-cost alternative will have significant impact,” Jake Frenz, CEO and founder of SmithRx, said in a statement. “We’re excited to work with Cost Plus Drugs to bring this biosimilar to our members – and significantly reduce costs for them and their employers.”

A version of this article first appeared on Medscape.com.

Adalimumab, sold under the brand name Humira, enjoyed a long run as one of the world’s best-selling medicines. But its 20-year, competition-free period has ended, and despite its best efforts to delay their arrival, drug manufacturer AbbVie now faces increasing competition from biosimilars entering the marketplace.
 

But one biosimilar about to be launched may be something of a game changer. Coherus BioSciences has announced plans to market its biosimilar Yusimry (adalimumab-aqvh) at a cost of $995 for two autoinjectors. This represents an approximate 85% discount over Humira’s sale list price of $6922.

This price, however, is slated to plunge even further as Coherus has also revealed that it will work with the Mark Cuban Cost Plus Drug Company (MCCPDC) to offer an even lower price. When Yusimry launches in July, it will sell for about $579 for two autoinjectors, making it the lowest-priced adalimumab biosimilar on the market.

“Coherus and Cost Plus Drug Company share a common mission, to increase access to high-quality medicine for patients at an affordable price,” said Dennis Lanfear, MBA, president, CEO and chairman of Coherus. “Mark Cuban and his team offer innovative solutions to health care problems, and Coherus is also a highly innovative company focused on unmet patient needs.”

He noted that, with adalimumab biosimilar pricing, this translates to a low list price approach. “We are pleased that Yusimry will be a part of that, as the first biologic they carry,” Mr. Lanfear said.

MCCPDC prices are based on the cost of ingredients and manufacturing plus 15% margin, a $3 pharmacy dispensing fee, and a $5 shipping fee. The company has expanded its inventory from 100 generics to more than 350 medications since it launched in January 2022. While MCCPDC is primarily directed to people who are paying cash for drugs, it does take insurance from select plans. And even for people who are covered by other insurers, the cost of drugs from Mr. Cuban’s company may be less than their out-of-pocket costs if they did go through their payer.

The low pricing of Yusimry is welcome, said Marcus Snow, MD, an assistant professor in the division of rheumatology at the University of Nebraska Medical Center, Omaha, but he pointed out that it is still a very expensive drug. “For patients who can’t afford Humira due to poor insurance coverage and high out-of-pocket costs, it is a welcome option. But it’s also unclear how many patients who lack adequate health insurance coverage can afford to pay $579 a month out of their own pockets.”
 

The biosimilars are coming

By early December 2022, the Food and Drug Administration had approved seven Humira biosimilars, and Amgen launched the first biosimilar to come on the market, Amjevita, soon afterward. By July 2023, half a dozen more are expected to enter the marketplace, said Steven Horvitz, managing director of EMC Analytics Group, a pharmaceutical research firm.

Mr. Horvitz agrees that the system is out of control, but it is unclear how much of an effect the low price tag on the Coherus product will have. “Some insurers may say, ‘we want the lowest price, and we don’t care about rebates,’ and will go with it,” he said. “PBMs [pharmacy benefit managers] are all about economics, so we have to see how many of their major clients will ask for the lowest price.”

Amgen has more or less followed the status quo on pricing for its biosimilar, but with a twist. It›s being offered at two different prices: $85,494 a year, which is only a 5% discount from Humira’s list price, or at $40,497 a year, a 55% discount. However, to date, the lower price has generally not been granted favorable formulary placement by PBMs. The plans that adopt the higher-priced biosimilar will get bigger rebates, but patients with coinsurance and deductibles will pay more out of pocket.

It is yet unknown how the pricing on Yusimry will affect the biosimilars ready to launch. “Will it give them pause for thought or not make any difference?” Mr. Horvitz said. “The companies do not reveal their pricing before the fact, so we have to wait and see.”

Large PBMs have not jumped at the opportunity to offer the Coherus biosimilar, but SmithRx, which bills itself as “next-generation pharmacy benefits management,” announced that it will offer Yusimry to its members at a discount of more than 90%.

“Unlike traditional PBMs, SmithRx prioritizes transparency and up-front cost savings. Humira is often an employer’s top drug expense so offering a low-cost alternative will have significant impact,” Jake Frenz, CEO and founder of SmithRx, said in a statement. “We’re excited to work with Cost Plus Drugs to bring this biosimilar to our members – and significantly reduce costs for them and their employers.”

A version of this article first appeared on Medscape.com.

Specific sun protection tips may vary by climate, but in San Diego, where the UV Index hovers in the moderate to high range on most days, Lawrence F. Eichenfield, MD, favors an aggressive approach.

“I basically say, ‘sun protection means clothing, shade, [considering the] time of day of exposure, and sunscreen if you are going to be otherwise exposed,’ ” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego, said during a panel discussion about sunscreen use at the Hawaii Dermatology Seminar provided by MedscapeLIVE! He recommends photoprotective gear such as rash guards for surfers and other water sport enthusiasts. When patients ask him if they should use sunscreen, he often replies with a question of his own.

Doug Brunk/MDedge News

“Do you brush your teeth?” he’ll ask.

“Yes, I do.”

“Well, you should put sunscreen on every day.”

Another panelist, Adelaide A. Hebert, MD, professor of dermatology and pediatrics and chief of pediatric dermatology at the University of Texas, Houston, said that she advises new parents to start sun protection efforts early. “Most sunscreens are not approved for use in children under the age of 6 months because testing has not been done in this age group, but I do recommend protective clothing. I also recommend wrap-around sunglasses, which offer 5% more protection from the sun than regular sunglasses.”

In her opinion, stick sunscreens are “a good add-on,” especially for under the eyes and the backs of the hands, but she is not a fan of spray sunscreens, which can leave large areas of skin unprotected if not applied properly.

Fellow panelist Jennifer Huang, MD, a pediatric dermatologist at Boston Children’s Hospital, who has a special interest in taking care of dermatologic conditions of children with cancer, generally recommends mineral-based sunscreens. “There is data to suggest that nonmineral sunscreens are less safe than mineral sunscreens for humans, and mineral sunscreens are considered to be better for the environment,” Dr. Huang said. “Plus, there are more elegant versions of mineral sunscreens that don’t make your skin pasty white.” However, for patients with darker skin tones, “it can be hard to apply a pasty white sunscreen, so I lean on some recommendations for tinted sunscreens, too, so there are options. I specifically recommend sunscreens that have iron oxides in them so that it can block physical rays and help with the cosmetic appearance.”

Moise Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, said that his approach to imparting sunscreen advice to children and their parents involves a mix of spoken information, printed information, and sunscreen samples for children to try in the office, in the presence of a parent. To help patients choose among different samples, be they ointments, gels, or lotions, he will often ask the child: “‘What do you like the feel of better?’ If the child says, ‘I like this one,’ I make sure the parent hears that,” Dr. Levy said.

Vesna Andjic/iStockphoto

Next, Dr. Eichenfield, who moderated the discussion, asked his fellow panelists how they would counsel someone who comes to their practice for evaluation of moles and has a family history of nonmelanoma skin cancer. “I think this is one of the easier counseling sessions, because there are enough kids who are asked about the moles on their skin when they’re at school,” Dr. Hebert said. “I think they’re very ready to wear sun protective clothing and I certainly don’t want any sun exposure that would pose an increased risk for their child.”

In addition to routine sun protection, Dr. Huang recommends annual mole checks for children who have a first-degree relative with a history of malignant melanoma. Other high-risk groups that should undergo annual skin exams include anyone who has received high doses of radiation, bone marrow transplants, prolonged use of voriconazole, or prolonged systemic immunosuppression. Without a known genetic predisposition syndrome, a family history of nonmelanoma skin cancer would not raise concern for melanoma in an otherwise healthy child.

Dr. Eichenfield added that freckling used to be the secondary risk factor for melanoma, “but it’s flipped over to a primary risk factor. A history of immunosuppression or prior cancer is a major risk factor in childhood and teenage years.”

Dr. Eichenfield disclosed that he is a consultant or adviser for numerous pharmaceutical companies. He has also received research funding from AbbVie, Bausch & Lomb, Galderma Laboratories, and Pfizer. Dr. Hebert disclosed that she is a consultant or adviser for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica. Dr. Levy disclosed that he is consultant or adviser for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. Dr. Huang disclosed that she is an adviser for EllaOla.

MedscapeLive! and this news organization are owned by the same parent company.
 

Specific sun protection tips may vary by climate, but in San Diego, where the UV Index hovers in the moderate to high range on most days, Lawrence F. Eichenfield, MD, favors an aggressive approach.

“I basically say, ‘sun protection means clothing, shade, [considering the] time of day of exposure, and sunscreen if you are going to be otherwise exposed,’ ” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego, said during a panel discussion about sunscreen use at the Hawaii Dermatology Seminar provided by MedscapeLIVE! He recommends photoprotective gear such as rash guards for surfers and other water sport enthusiasts. When patients ask him if they should use sunscreen, he often replies with a question of his own.

Doug Brunk/MDedge News

“Do you brush your teeth?” he’ll ask.

“Yes, I do.”

“Well, you should put sunscreen on every day.”

Another panelist, Adelaide A. Hebert, MD, professor of dermatology and pediatrics and chief of pediatric dermatology at the University of Texas, Houston, said that she advises new parents to start sun protection efforts early. “Most sunscreens are not approved for use in children under the age of 6 months because testing has not been done in this age group, but I do recommend protective clothing. I also recommend wrap-around sunglasses, which offer 5% more protection from the sun than regular sunglasses.”

In her opinion, stick sunscreens are “a good add-on,” especially for under the eyes and the backs of the hands, but she is not a fan of spray sunscreens, which can leave large areas of skin unprotected if not applied properly.

Fellow panelist Jennifer Huang, MD, a pediatric dermatologist at Boston Children’s Hospital, who has a special interest in taking care of dermatologic conditions of children with cancer, generally recommends mineral-based sunscreens. “There is data to suggest that nonmineral sunscreens are less safe than mineral sunscreens for humans, and mineral sunscreens are considered to be better for the environment,” Dr. Huang said. “Plus, there are more elegant versions of mineral sunscreens that don’t make your skin pasty white.” However, for patients with darker skin tones, “it can be hard to apply a pasty white sunscreen, so I lean on some recommendations for tinted sunscreens, too, so there are options. I specifically recommend sunscreens that have iron oxides in them so that it can block physical rays and help with the cosmetic appearance.”

Moise Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, said that his approach to imparting sunscreen advice to children and their parents involves a mix of spoken information, printed information, and sunscreen samples for children to try in the office, in the presence of a parent. To help patients choose among different samples, be they ointments, gels, or lotions, he will often ask the child: “‘What do you like the feel of better?’ If the child says, ‘I like this one,’ I make sure the parent hears that,” Dr. Levy said.

Vesna Andjic/iStockphoto

Next, Dr. Eichenfield, who moderated the discussion, asked his fellow panelists how they would counsel someone who comes to their practice for evaluation of moles and has a family history of nonmelanoma skin cancer. “I think this is one of the easier counseling sessions, because there are enough kids who are asked about the moles on their skin when they’re at school,” Dr. Hebert said. “I think they’re very ready to wear sun protective clothing and I certainly don’t want any sun exposure that would pose an increased risk for their child.”

In addition to routine sun protection, Dr. Huang recommends annual mole checks for children who have a first-degree relative with a history of malignant melanoma. Other high-risk groups that should undergo annual skin exams include anyone who has received high doses of radiation, bone marrow transplants, prolonged use of voriconazole, or prolonged systemic immunosuppression. Without a known genetic predisposition syndrome, a family history of nonmelanoma skin cancer would not raise concern for melanoma in an otherwise healthy child.

Dr. Eichenfield added that freckling used to be the secondary risk factor for melanoma, “but it’s flipped over to a primary risk factor. A history of immunosuppression or prior cancer is a major risk factor in childhood and teenage years.”

Dr. Eichenfield disclosed that he is a consultant or adviser for numerous pharmaceutical companies. He has also received research funding from AbbVie, Bausch & Lomb, Galderma Laboratories, and Pfizer. Dr. Hebert disclosed that she is a consultant or adviser for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica. Dr. Levy disclosed that he is consultant or adviser for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. Dr. Huang disclosed that she is an adviser for EllaOla.

MedscapeLive! and this news organization are owned by the same parent company.
 

Specific sun protection tips may vary by climate, but in San Diego, where the UV Index hovers in the moderate to high range on most days, Lawrence F. Eichenfield, MD, favors an aggressive approach.

“I basically say, ‘sun protection means clothing, shade, [considering the] time of day of exposure, and sunscreen if you are going to be otherwise exposed,’ ” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego, said during a panel discussion about sunscreen use at the Hawaii Dermatology Seminar provided by MedscapeLIVE! He recommends photoprotective gear such as rash guards for surfers and other water sport enthusiasts. When patients ask him if they should use sunscreen, he often replies with a question of his own.

Doug Brunk/MDedge News

“Do you brush your teeth?” he’ll ask.

“Yes, I do.”

“Well, you should put sunscreen on every day.”

Another panelist, Adelaide A. Hebert, MD, professor of dermatology and pediatrics and chief of pediatric dermatology at the University of Texas, Houston, said that she advises new parents to start sun protection efforts early. “Most sunscreens are not approved for use in children under the age of 6 months because testing has not been done in this age group, but I do recommend protective clothing. I also recommend wrap-around sunglasses, which offer 5% more protection from the sun than regular sunglasses.”

In her opinion, stick sunscreens are “a good add-on,” especially for under the eyes and the backs of the hands, but she is not a fan of spray sunscreens, which can leave large areas of skin unprotected if not applied properly.

Fellow panelist Jennifer Huang, MD, a pediatric dermatologist at Boston Children’s Hospital, who has a special interest in taking care of dermatologic conditions of children with cancer, generally recommends mineral-based sunscreens. “There is data to suggest that nonmineral sunscreens are less safe than mineral sunscreens for humans, and mineral sunscreens are considered to be better for the environment,” Dr. Huang said. “Plus, there are more elegant versions of mineral sunscreens that don’t make your skin pasty white.” However, for patients with darker skin tones, “it can be hard to apply a pasty white sunscreen, so I lean on some recommendations for tinted sunscreens, too, so there are options. I specifically recommend sunscreens that have iron oxides in them so that it can block physical rays and help with the cosmetic appearance.”

Moise Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, said that his approach to imparting sunscreen advice to children and their parents involves a mix of spoken information, printed information, and sunscreen samples for children to try in the office, in the presence of a parent. To help patients choose among different samples, be they ointments, gels, or lotions, he will often ask the child: “‘What do you like the feel of better?’ If the child says, ‘I like this one,’ I make sure the parent hears that,” Dr. Levy said.

Vesna Andjic/iStockphoto

Next, Dr. Eichenfield, who moderated the discussion, asked his fellow panelists how they would counsel someone who comes to their practice for evaluation of moles and has a family history of nonmelanoma skin cancer. “I think this is one of the easier counseling sessions, because there are enough kids who are asked about the moles on their skin when they’re at school,” Dr. Hebert said. “I think they’re very ready to wear sun protective clothing and I certainly don’t want any sun exposure that would pose an increased risk for their child.”

In addition to routine sun protection, Dr. Huang recommends annual mole checks for children who have a first-degree relative with a history of malignant melanoma. Other high-risk groups that should undergo annual skin exams include anyone who has received high doses of radiation, bone marrow transplants, prolonged use of voriconazole, or prolonged systemic immunosuppression. Without a known genetic predisposition syndrome, a family history of nonmelanoma skin cancer would not raise concern for melanoma in an otherwise healthy child.

Dr. Eichenfield added that freckling used to be the secondary risk factor for melanoma, “but it’s flipped over to a primary risk factor. A history of immunosuppression or prior cancer is a major risk factor in childhood and teenage years.”

Dr. Eichenfield disclosed that he is a consultant or adviser for numerous pharmaceutical companies. He has also received research funding from AbbVie, Bausch & Lomb, Galderma Laboratories, and Pfizer. Dr. Hebert disclosed that she is a consultant or adviser for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica. Dr. Levy disclosed that he is consultant or adviser for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. Dr. Huang disclosed that she is an adviser for EllaOla.

MedscapeLive! and this news organization are owned by the same parent company.
 

A new study suggests that prescriptions for low-dose oral minoxidil soared in the wake of a 2022 New York Times article that highlighted its utility for hair loss.

©herkisi/iStockphoto.com

The weekly rate of first-time low-dose oral minoxidil (LDOM) prescriptions per 10,000 outpatient encounters was “significantly higher 8 weeks after vs. 8 weeks before article publication,” at 0.9 prescriptions, compared with 0.5 per 10,000, wrote the authors of the research letter, published in JAMA Network Open. There was no similar bump for first-time finasteride or hypertension prescriptions, wrote the authors, from Harvard Medical School and Massachusetts General Hospital, Boston, and Truveta, a company that provides EHR data from U.S. health care systems.

The New York Times article noted that LDOM was relatively unknown to patients and doctors – and not approved by the Food and Drug Administration for treating hair loss – but that it was inexpensive, safe, and very effective for many individuals. “The article did not report new research findings or large-scale randomized evidence,” wrote the authors of the JAMA study.

In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said that he was not surprised to see an uptick in prescriptions after the Times article.

He and his colleagues were curious as to whether the article might have prompted newfound interest in LDOM. They experienced an uptick at George Washington, which Dr. Friedman thought could have been because he was quoted in the Times story. He and colleagues conducted a national survey of dermatologists asking if more patients had called, emailed, or come in to the office asking about LDOM after the article’s publication. “Over 85% said yes,” Dr. Friedman said in the interview. He and his coauthors also found a huge increase in Google searches for terms such as hair loss, alopecia, and minoxidil in the weeks after the article, he said.

The results are expected to published soon in the Journal of Drugs in Dermatology.

“I think a lot of people know about [LDOM] and it’s certainly has gained a lot more attention and acceptance in recent years,” said Dr. Friedman, but he added that “there’s no question” that the Times article increased interest.

That is not necessarily a bad thing, he said. “With one article, education on a common disease was disseminated worldwide in a way that no one doctor can do,” he said. The article was truthful, evidence-based, and included expert dermatologists, he noted.

“It probably got people who never thought twice about their hair thinning to actually think that there’s hope,” he said, adding that it also likely prompted them to seek care, and, more importantly, “to seek care from the person who should be taking care of this, which is the dermatologist.”

However, the article might also inspire some people to think LDOM can help when it can’t, or they might insist on a prescription when another medication is more appropriate, said Dr. Friedman.

Both he and Dr. Sinclair expect demand for LDOM to continue increasing.

“Word of mouth will drive the next wave of prescriptions,” said Dr. Sinclair. “We are continuing to do work to improve safety, to understand its mechanism of action, and identify ways to improve equity of access to treatment for men and women who are concerned about their hair loss and motivated to treat it,” he said.

Dr. Sinclair and Dr. Friedman report no relevant financial relationships.

A new study suggests that prescriptions for low-dose oral minoxidil soared in the wake of a 2022 New York Times article that highlighted its utility for hair loss.

©herkisi/iStockphoto.com

The weekly rate of first-time low-dose oral minoxidil (LDOM) prescriptions per 10,000 outpatient encounters was “significantly higher 8 weeks after vs. 8 weeks before article publication,” at 0.9 prescriptions, compared with 0.5 per 10,000, wrote the authors of the research letter, published in JAMA Network Open. There was no similar bump for first-time finasteride or hypertension prescriptions, wrote the authors, from Harvard Medical School and Massachusetts General Hospital, Boston, and Truveta, a company that provides EHR data from U.S. health care systems.

The New York Times article noted that LDOM was relatively unknown to patients and doctors – and not approved by the Food and Drug Administration for treating hair loss – but that it was inexpensive, safe, and very effective for many individuals. “The article did not report new research findings or large-scale randomized evidence,” wrote the authors of the JAMA study.

In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said that he was not surprised to see an uptick in prescriptions after the Times article.

He and his colleagues were curious as to whether the article might have prompted newfound interest in LDOM. They experienced an uptick at George Washington, which Dr. Friedman thought could have been because he was quoted in the Times story. He and colleagues conducted a national survey of dermatologists asking if more patients had called, emailed, or come in to the office asking about LDOM after the article’s publication. “Over 85% said yes,” Dr. Friedman said in the interview. He and his coauthors also found a huge increase in Google searches for terms such as hair loss, alopecia, and minoxidil in the weeks after the article, he said.

The results are expected to published soon in the Journal of Drugs in Dermatology.

“I think a lot of people know about [LDOM] and it’s certainly has gained a lot more attention and acceptance in recent years,” said Dr. Friedman, but he added that “there’s no question” that the Times article increased interest.

That is not necessarily a bad thing, he said. “With one article, education on a common disease was disseminated worldwide in a way that no one doctor can do,” he said. The article was truthful, evidence-based, and included expert dermatologists, he noted.

“It probably got people who never thought twice about their hair thinning to actually think that there’s hope,” he said, adding that it also likely prompted them to seek care, and, more importantly, “to seek care from the person who should be taking care of this, which is the dermatologist.”

However, the article might also inspire some people to think LDOM can help when it can’t, or they might insist on a prescription when another medication is more appropriate, said Dr. Friedman.

Both he and Dr. Sinclair expect demand for LDOM to continue increasing.

“Word of mouth will drive the next wave of prescriptions,” said Dr. Sinclair. “We are continuing to do work to improve safety, to understand its mechanism of action, and identify ways to improve equity of access to treatment for men and women who are concerned about their hair loss and motivated to treat it,” he said.

Dr. Sinclair and Dr. Friedman report no relevant financial relationships.

A new study suggests that prescriptions for low-dose oral minoxidil soared in the wake of a 2022 New York Times article that highlighted its utility for hair loss.

©herkisi/iStockphoto.com

The weekly rate of first-time low-dose oral minoxidil (LDOM) prescriptions per 10,000 outpatient encounters was “significantly higher 8 weeks after vs. 8 weeks before article publication,” at 0.9 prescriptions, compared with 0.5 per 10,000, wrote the authors of the research letter, published in JAMA Network Open. There was no similar bump for first-time finasteride or hypertension prescriptions, wrote the authors, from Harvard Medical School and Massachusetts General Hospital, Boston, and Truveta, a company that provides EHR data from U.S. health care systems.

The New York Times article noted that LDOM was relatively unknown to patients and doctors – and not approved by the Food and Drug Administration for treating hair loss – but that it was inexpensive, safe, and very effective for many individuals. “The article did not report new research findings or large-scale randomized evidence,” wrote the authors of the JAMA study.

In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said that he was not surprised to see an uptick in prescriptions after the Times article.

He and his colleagues were curious as to whether the article might have prompted newfound interest in LDOM. They experienced an uptick at George Washington, which Dr. Friedman thought could have been because he was quoted in the Times story. He and colleagues conducted a national survey of dermatologists asking if more patients had called, emailed, or come in to the office asking about LDOM after the article’s publication. “Over 85% said yes,” Dr. Friedman said in the interview. He and his coauthors also found a huge increase in Google searches for terms such as hair loss, alopecia, and minoxidil in the weeks after the article, he said.

The results are expected to published soon in the Journal of Drugs in Dermatology.

“I think a lot of people know about [LDOM] and it’s certainly has gained a lot more attention and acceptance in recent years,” said Dr. Friedman, but he added that “there’s no question” that the Times article increased interest.

That is not necessarily a bad thing, he said. “With one article, education on a common disease was disseminated worldwide in a way that no one doctor can do,” he said. The article was truthful, evidence-based, and included expert dermatologists, he noted.

“It probably got people who never thought twice about their hair thinning to actually think that there’s hope,” he said, adding that it also likely prompted them to seek care, and, more importantly, “to seek care from the person who should be taking care of this, which is the dermatologist.”

However, the article might also inspire some people to think LDOM can help when it can’t, or they might insist on a prescription when another medication is more appropriate, said Dr. Friedman.

Both he and Dr. Sinclair expect demand for LDOM to continue increasing.

“Word of mouth will drive the next wave of prescriptions,” said Dr. Sinclair. “We are continuing to do work to improve safety, to understand its mechanism of action, and identify ways to improve equity of access to treatment for men and women who are concerned about their hair loss and motivated to treat it,” he said.

Dr. Sinclair and Dr. Friedman report no relevant financial relationships.

Infections were the most common adverse events associated with the use of microwave energy devices for hyperhidrosis over a 9-year period, an analysis of reports submitted to the FDA Manufacturer and User Facility Device Experience (MAUDE) database showed.

While microwave energy devices (MEDs) are used to treat hyperhidrosis, the largest MED clinical trial included only 101 patients, Samantha Jo Albucker and Shari Lipner, MD, PhD, wrote in a research letter reporting the results.

For the study, published online in the Journal of the American Academy of Dermatology, Ms. Albucker, a student at Tulane University, New Orleans, and Dr. Lipner, associate professor of clinical dermatology at Weill Cornell Medicine, New York, searched the MAUDE database between Feb. 28, 2013, and Dec. 29, 2022, for adverse events (AEs) involving MEDs for hyperhidrosis treatment. Of the 502 medical device reports identified over the study period, the axilla was the most frequent injury site in 50.4% of cases. The three most common complications were infections (45.4%); neurological symptoms including neuropathy, nerve damage, and numbness (21.7%); and burns/ulcerations/erosions (19.1%).

In other findings, 2.4% of patients required hospitalization, most often because of infection (83.3%), followed by burn and coma (8.3% each). The average symptom onset was 2 months postprocedure, and the most common treatment was antibiotics in 62.2% of cases, followed by incision and drainage/aspiration in 21.7% of cases.

A codiagnosis of hidradenitis suppurativa (HS) was reported in 5.4% of all medical device reports. The researchers noted that in a published randomized clinical trial of eight HS patients undergoing MED treatment to assess the effect on HS symptoms, the treatment showed no clinical advantage. In addition, they referred to two case reports describing new-onset HS after MED treatment for hyperhidrosis.

“Therefore, we recommend questioning patients about HS history and examining for HS clinical findings before performing MED for hyperhidrosis,” they wrote, adding that the data, “taken together, suggests that avoidance of MED treatment of hyperhidrosis in HS patients is prudent and alternative treatments may be prescribed.”

The researchers acknowledged certain limitations of their analysis, including uncompleted medical device reports, patient reporting, and unverified causes of adverse events. “Large multicenter studies are needed to corroborate our results,” they concluded.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, said that primary idiopathic hyperhidrosis is a common medical condition that is often overlooked as a legitimate concern, and causes a quality-of-life burden. “Even with the striking numbers in the millions, there are limited treatment options available for axillary let alone other forms of primary hyperhidrosis,” said Dr. Friedman, who was not involved with the study.

“Therefore, for the short treatment list we have, it is important to have some predictive power with respect to clinical impact to provide realistic expectations as well as potential adverse events to ensure best practices and meaningful patient guidance. In this research letter, our colleagues highlight complications that can ensue from microwave therapy for hyperhidrosis and the frequency of said adverse events. Knowing these data is half the battle, and I for one would not have assumed infection was number one on the list of adverse events.”

Ms. Albucker had no relevant conflicts of interest to disclose. Dr. Lipner disclosed that she has served as a consultant for Ortho Dermatologics, Hoth Therapeutics, BelleTorus Corporation, and Moberg Pharmaceuticals.

Dr. Friedman disclosed that he is a consultant and/or advisory board member for Medscape/SanovaWorks, Oakstone Institute, L’Oréal, La Roche Posay, Galderma, Aveeno, Ortho Dermatologic, Microcures, Pfizer, Novartis, Lilly, Hoth Therapeutics, Zylo Therapeutics, BMS, Vial, Janssen, Novocure, Dermavant, Regeneron/Sanofi, and Incyte. He has also received grants from Pfizer, the Dermatology Foundation, Lilly, Janssen, Incyte, and Galderma.

Infections were the most common adverse events associated with the use of microwave energy devices for hyperhidrosis over a 9-year period, an analysis of reports submitted to the FDA Manufacturer and User Facility Device Experience (MAUDE) database showed.

While microwave energy devices (MEDs) are used to treat hyperhidrosis, the largest MED clinical trial included only 101 patients, Samantha Jo Albucker and Shari Lipner, MD, PhD, wrote in a research letter reporting the results.

For the study, published online in the Journal of the American Academy of Dermatology, Ms. Albucker, a student at Tulane University, New Orleans, and Dr. Lipner, associate professor of clinical dermatology at Weill Cornell Medicine, New York, searched the MAUDE database between Feb. 28, 2013, and Dec. 29, 2022, for adverse events (AEs) involving MEDs for hyperhidrosis treatment. Of the 502 medical device reports identified over the study period, the axilla was the most frequent injury site in 50.4% of cases. The three most common complications were infections (45.4%); neurological symptoms including neuropathy, nerve damage, and numbness (21.7%); and burns/ulcerations/erosions (19.1%).

In other findings, 2.4% of patients required hospitalization, most often because of infection (83.3%), followed by burn and coma (8.3% each). The average symptom onset was 2 months postprocedure, and the most common treatment was antibiotics in 62.2% of cases, followed by incision and drainage/aspiration in 21.7% of cases.

A codiagnosis of hidradenitis suppurativa (HS) was reported in 5.4% of all medical device reports. The researchers noted that in a published randomized clinical trial of eight HS patients undergoing MED treatment to assess the effect on HS symptoms, the treatment showed no clinical advantage. In addition, they referred to two case reports describing new-onset HS after MED treatment for hyperhidrosis.

“Therefore, we recommend questioning patients about HS history and examining for HS clinical findings before performing MED for hyperhidrosis,” they wrote, adding that the data, “taken together, suggests that avoidance of MED treatment of hyperhidrosis in HS patients is prudent and alternative treatments may be prescribed.”

The researchers acknowledged certain limitations of their analysis, including uncompleted medical device reports, patient reporting, and unverified causes of adverse events. “Large multicenter studies are needed to corroborate our results,” they concluded.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, said that primary idiopathic hyperhidrosis is a common medical condition that is often overlooked as a legitimate concern, and causes a quality-of-life burden. “Even with the striking numbers in the millions, there are limited treatment options available for axillary let alone other forms of primary hyperhidrosis,” said Dr. Friedman, who was not involved with the study.

“Therefore, for the short treatment list we have, it is important to have some predictive power with respect to clinical impact to provide realistic expectations as well as potential adverse events to ensure best practices and meaningful patient guidance. In this research letter, our colleagues highlight complications that can ensue from microwave therapy for hyperhidrosis and the frequency of said adverse events. Knowing these data is half the battle, and I for one would not have assumed infection was number one on the list of adverse events.”

Ms. Albucker had no relevant conflicts of interest to disclose. Dr. Lipner disclosed that she has served as a consultant for Ortho Dermatologics, Hoth Therapeutics, BelleTorus Corporation, and Moberg Pharmaceuticals.

Dr. Friedman disclosed that he is a consultant and/or advisory board member for Medscape/SanovaWorks, Oakstone Institute, L’Oréal, La Roche Posay, Galderma, Aveeno, Ortho Dermatologic, Microcures, Pfizer, Novartis, Lilly, Hoth Therapeutics, Zylo Therapeutics, BMS, Vial, Janssen, Novocure, Dermavant, Regeneron/Sanofi, and Incyte. He has also received grants from Pfizer, the Dermatology Foundation, Lilly, Janssen, Incyte, and Galderma.

Infections were the most common adverse events associated with the use of microwave energy devices for hyperhidrosis over a 9-year period, an analysis of reports submitted to the FDA Manufacturer and User Facility Device Experience (MAUDE) database showed.

While microwave energy devices (MEDs) are used to treat hyperhidrosis, the largest MED clinical trial included only 101 patients, Samantha Jo Albucker and Shari Lipner, MD, PhD, wrote in a research letter reporting the results.

For the study, published online in the Journal of the American Academy of Dermatology, Ms. Albucker, a student at Tulane University, New Orleans, and Dr. Lipner, associate professor of clinical dermatology at Weill Cornell Medicine, New York, searched the MAUDE database between Feb. 28, 2013, and Dec. 29, 2022, for adverse events (AEs) involving MEDs for hyperhidrosis treatment. Of the 502 medical device reports identified over the study period, the axilla was the most frequent injury site in 50.4% of cases. The three most common complications were infections (45.4%); neurological symptoms including neuropathy, nerve damage, and numbness (21.7%); and burns/ulcerations/erosions (19.1%).

In other findings, 2.4% of patients required hospitalization, most often because of infection (83.3%), followed by burn and coma (8.3% each). The average symptom onset was 2 months postprocedure, and the most common treatment was antibiotics in 62.2% of cases, followed by incision and drainage/aspiration in 21.7% of cases.

A codiagnosis of hidradenitis suppurativa (HS) was reported in 5.4% of all medical device reports. The researchers noted that in a published randomized clinical trial of eight HS patients undergoing MED treatment to assess the effect on HS symptoms, the treatment showed no clinical advantage. In addition, they referred to two case reports describing new-onset HS after MED treatment for hyperhidrosis.

“Therefore, we recommend questioning patients about HS history and examining for HS clinical findings before performing MED for hyperhidrosis,” they wrote, adding that the data, “taken together, suggests that avoidance of MED treatment of hyperhidrosis in HS patients is prudent and alternative treatments may be prescribed.”

The researchers acknowledged certain limitations of their analysis, including uncompleted medical device reports, patient reporting, and unverified causes of adverse events. “Large multicenter studies are needed to corroborate our results,” they concluded.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, said that primary idiopathic hyperhidrosis is a common medical condition that is often overlooked as a legitimate concern, and causes a quality-of-life burden. “Even with the striking numbers in the millions, there are limited treatment options available for axillary let alone other forms of primary hyperhidrosis,” said Dr. Friedman, who was not involved with the study.

“Therefore, for the short treatment list we have, it is important to have some predictive power with respect to clinical impact to provide realistic expectations as well as potential adverse events to ensure best practices and meaningful patient guidance. In this research letter, our colleagues highlight complications that can ensue from microwave therapy for hyperhidrosis and the frequency of said adverse events. Knowing these data is half the battle, and I for one would not have assumed infection was number one on the list of adverse events.”

Ms. Albucker had no relevant conflicts of interest to disclose. Dr. Lipner disclosed that she has served as a consultant for Ortho Dermatologics, Hoth Therapeutics, BelleTorus Corporation, and Moberg Pharmaceuticals.

Dr. Friedman disclosed that he is a consultant and/or advisory board member for Medscape/SanovaWorks, Oakstone Institute, L’Oréal, La Roche Posay, Galderma, Aveeno, Ortho Dermatologic, Microcures, Pfizer, Novartis, Lilly, Hoth Therapeutics, Zylo Therapeutics, BMS, Vial, Janssen, Novocure, Dermavant, Regeneron/Sanofi, and Incyte. He has also received grants from Pfizer, the Dermatology Foundation, Lilly, Janssen, Incyte, and Galderma.

Dermoscopy showed not only the erythema, inflammation, and crusting visible during the initial examination, but it also revealed that each lesion had a hair growing through it. This pointed to a diagnosis of superficial folliculitis of the scalp.

The physician ruled out tinea capitis, acne keloidalis nuchae, and scarring alopecia based on the dermoscopic exam. There were no broken hairs that one would expect with tinea capitis. Also, there was no polytrichia (multiple hairs pushed into a single follicular opening due to scarring of the skin) that would be expected with acne keloidalis nuchae and scarring alopecias.

There are multiple types of scalp folliculitis. This patient had superficial folliculitis, in which pustules develop at the ostium of the hair follicles. Deep folliculitis is more severe and includes furuncles and carbuncles.¹

Folliculitis is usually caused by a bacterial infection and, less commonly, fungal infection. In addition to superficial and deep folliculitis, inflammation with scarring of the follicles occurs with folliculitis decalvans, which is one of the scarring alopecias.¹

Mild cases of superficial bacterial folliculitis are treated with topical antibiotics (eg, topical clindamycin 1% applied twice daily). Depending on the severity, oral antibiotics including doxycycline 100 mg twice daily for 7 days or trimethoprim sulfamethoxazole 160 mg/800 mg (double strength) twice daily for 7 days may be used. There is also a chronic nonscarring form of scalp folliculitis that often responds initially to antibiotics but then recurs. This has been treated with longer courses of oral antibiotics and, if the lesions don’t respond or continue to recur, with low-dose isotretinoin.²

Due to the amount of scalp involvement, crusting, and inflammation seen on this patient’s scalp, he was treated with trimethoprim sulfamethoxazole 160 mg/800 mg twice daily for 7 days. After 1 week, he reported that he was doing much better and that the lesions had nearly resolved. He was told to return for reevaluation if the lesions did not completely resolve.

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Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Dermoscopy showed not only the erythema, inflammation, and crusting visible during the initial examination, but it also revealed that each lesion had a hair growing through it. This pointed to a diagnosis of superficial folliculitis of the scalp.

The physician ruled out tinea capitis, acne keloidalis nuchae, and scarring alopecia based on the dermoscopic exam. There were no broken hairs that one would expect with tinea capitis. Also, there was no polytrichia (multiple hairs pushed into a single follicular opening due to scarring of the skin) that would be expected with acne keloidalis nuchae and scarring alopecias.

There are multiple types of scalp folliculitis. This patient had superficial folliculitis, in which pustules develop at the ostium of the hair follicles. Deep folliculitis is more severe and includes furuncles and carbuncles.¹

Folliculitis is usually caused by a bacterial infection and, less commonly, fungal infection. In addition to superficial and deep folliculitis, inflammation with scarring of the follicles occurs with folliculitis decalvans, which is one of the scarring alopecias.¹

Mild cases of superficial bacterial folliculitis are treated with topical antibiotics (eg, topical clindamycin 1% applied twice daily). Depending on the severity, oral antibiotics including doxycycline 100 mg twice daily for 7 days or trimethoprim sulfamethoxazole 160 mg/800 mg (double strength) twice daily for 7 days may be used. There is also a chronic nonscarring form of scalp folliculitis that often responds initially to antibiotics but then recurs. This has been treated with longer courses of oral antibiotics and, if the lesions don’t respond or continue to recur, with low-dose isotretinoin.²

Due to the amount of scalp involvement, crusting, and inflammation seen on this patient’s scalp, he was treated with trimethoprim sulfamethoxazole 160 mg/800 mg twice daily for 7 days. After 1 week, he reported that he was doing much better and that the lesions had nearly resolved. He was told to return for reevaluation if the lesions did not completely resolve.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Dermoscopy showed not only the erythema, inflammation, and crusting visible during the initial examination, but it also revealed that each lesion had a hair growing through it. This pointed to a diagnosis of superficial folliculitis of the scalp.

The physician ruled out tinea capitis, acne keloidalis nuchae, and scarring alopecia based on the dermoscopic exam. There were no broken hairs that one would expect with tinea capitis. Also, there was no polytrichia (multiple hairs pushed into a single follicular opening due to scarring of the skin) that would be expected with acne keloidalis nuchae and scarring alopecias.

There are multiple types of scalp folliculitis. This patient had superficial folliculitis, in which pustules develop at the ostium of the hair follicles. Deep folliculitis is more severe and includes furuncles and carbuncles.¹

Folliculitis is usually caused by a bacterial infection and, less commonly, fungal infection. In addition to superficial and deep folliculitis, inflammation with scarring of the follicles occurs with folliculitis decalvans, which is one of the scarring alopecias.¹

Mild cases of superficial bacterial folliculitis are treated with topical antibiotics (eg, topical clindamycin 1% applied twice daily). Depending on the severity, oral antibiotics including doxycycline 100 mg twice daily for 7 days or trimethoprim sulfamethoxazole 160 mg/800 mg (double strength) twice daily for 7 days may be used. There is also a chronic nonscarring form of scalp folliculitis that often responds initially to antibiotics but then recurs. This has been treated with longer courses of oral antibiotics and, if the lesions don’t respond or continue to recur, with low-dose isotretinoin.²

Due to the amount of scalp involvement, crusting, and inflammation seen on this patient’s scalp, he was treated with trimethoprim sulfamethoxazole 160 mg/800 mg twice daily for 7 days. After 1 week, he reported that he was doing much better and that the lesions had nearly resolved. He was told to return for reevaluation if the lesions did not completely resolve.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

The clinical pattern of a scaly herald patch predating the eruption of multiple scaly macules is the hallmark of pityriasis rosea (PR). This patient’s severe itching is also classic for PR.

PR’s etiology is believed to be a reactivation of infection from human herpes viruses 6 and 7.¹ Prodromal viral symptoms of malaise, sore throat, myalgias, and fever are common.² Along with the prodromal symptoms, there is often a several-centimeter herald patch that occurs on the trunk. It is often confused with eczema or tinea due to its erythema and scale. (Secondary syphilis is also in the differential.) Sometimes PR can be differentiated by the scale pattern being a collarette instead of diffuse. The diagnosis becomes clearer 1 to 2 weeks later with the onset of multiple small scaly macules across the trunk following the Langer’s skin lines. The course is self-limited but takes several weeks to months to resolve.

If severe, PR may be treated with acyclovir 800 mg orally 5 times daily for 5 days; this is the same regimen for treating varicella zoster (shingles).^1,2 Estimated recurrence rates are 4% to 24%.^1,3

At age 49 years, this woman was older than the average patient with PR, as the usual age range is 10 to 35 years.¹ Her physician advised her that the outbreak might recur. She was also given a prescription for oral hydroxyzine 25 mg to be taken at bedtime if the itching was interfering with her sleep. Her physician told her to return for reevaluation if the rash did not resolve in 3 months. She did not return for reevaluation.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

The clinical pattern of a scaly herald patch predating the eruption of multiple scaly macules is the hallmark of pityriasis rosea (PR). This patient’s severe itching is also classic for PR.

PR’s etiology is believed to be a reactivation of infection from human herpes viruses 6 and 7.¹ Prodromal viral symptoms of malaise, sore throat, myalgias, and fever are common.² Along with the prodromal symptoms, there is often a several-centimeter herald patch that occurs on the trunk. It is often confused with eczema or tinea due to its erythema and scale. (Secondary syphilis is also in the differential.) Sometimes PR can be differentiated by the scale pattern being a collarette instead of diffuse. The diagnosis becomes clearer 1 to 2 weeks later with the onset of multiple small scaly macules across the trunk following the Langer’s skin lines. The course is self-limited but takes several weeks to months to resolve.

If severe, PR may be treated with acyclovir 800 mg orally 5 times daily for 5 days; this is the same regimen for treating varicella zoster (shingles).^1,2 Estimated recurrence rates are 4% to 24%.^1,3

At age 49 years, this woman was older than the average patient with PR, as the usual age range is 10 to 35 years.¹ Her physician advised her that the outbreak might recur. She was also given a prescription for oral hydroxyzine 25 mg to be taken at bedtime if the itching was interfering with her sleep. Her physician told her to return for reevaluation if the rash did not resolve in 3 months. She did not return for reevaluation.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

The clinical pattern of a scaly herald patch predating the eruption of multiple scaly macules is the hallmark of pityriasis rosea (PR). This patient’s severe itching is also classic for PR.

PR’s etiology is believed to be a reactivation of infection from human herpes viruses 6 and 7.¹ Prodromal viral symptoms of malaise, sore throat, myalgias, and fever are common.² Along with the prodromal symptoms, there is often a several-centimeter herald patch that occurs on the trunk. It is often confused with eczema or tinea due to its erythema and scale. (Secondary syphilis is also in the differential.) Sometimes PR can be differentiated by the scale pattern being a collarette instead of diffuse. The diagnosis becomes clearer 1 to 2 weeks later with the onset of multiple small scaly macules across the trunk following the Langer’s skin lines. The course is self-limited but takes several weeks to months to resolve.

If severe, PR may be treated with acyclovir 800 mg orally 5 times daily for 5 days; this is the same regimen for treating varicella zoster (shingles).^1,2 Estimated recurrence rates are 4% to 24%.^1,3

At age 49 years, this woman was older than the average patient with PR, as the usual age range is 10 to 35 years.¹ Her physician advised her that the outbreak might recur. She was also given a prescription for oral hydroxyzine 25 mg to be taken at bedtime if the itching was interfering with her sleep. Her physician told her to return for reevaluation if the rash did not resolve in 3 months. She did not return for reevaluation.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

A 30-YEAR-OLD MAN presented for evaluation of a solitary, flesh-colored, pedunculated mass on his right inner gluteal area (FIGURE) that had gradually enlarged over the previous 18 months. The lesion had manifested 4 years prior as a small papule that was stable for many years. It began to grow steadily after the patient compressed the papule forcefully. Activities of daily living, such as sitting, were now uncomfortable, so he sought treatment. He denied pain, pruritis, and bleeding and reported no history of trauma or surgery in the area of the mass.

On physical examination, the mass measured 3.5 × 4.5 cm with a 1.2-cm base. It was smooth, soft, nontender, and compressible—but nonfluctuant. There were no signs of ulceration or bleeding. No regional lymphadenopathy was noted. An excisional biopsy was performed.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

The biopsy confirmed a diagnosis of ­fibrolipoma—a rare variant of lipoma composed of a mixture of adipocytes and thick bands of fibrous connective tissues.¹ Etiology for fibrolipomas is unknown. Blunt trauma rupture of the fibrous septa that prevent fat migration may result in a proliferation of adipose tissue and thereby enlargement of fibrolipomas and other lipoma variants.² In this case, the patient’s compression of the original papule likely served as the trauma that led to its enlargement. Malignant change has not been reported with fibrolipomas.

What you’ll see—and on whom. ­Fibrolipomas typically are flesh-colored, ­pedunculated, compressible, and relatively asymp­tomatic.³ They have been reported on the face, neck, back, and pubic areas, among other locations. Size is variable; they can be as small as 1 cm in diameter and as large as 10 cm in diameter.⁴ However, fibrolipomas can grow to be “giant” if they exceed 10 cm (or 1000 g).²

The patient’s compression of the original papule likely served as the trauma that led to its enlargement.

Men and women are affected equally by fibrolipomas. Prevalence does not differ by race or ethnicity.

The differential include sother lipomas and skin tags

The differential for a mass such as this one includes lipomas, acrochordons (also known as skin tags), and fibrokeratomas.

Lipomas are the most common benign soft-tissue tumors and are composed of adipocytes.⁵ The fibrolipoma is just one variant of ­lipoma; others include the myxolipoma, myolipoma, spindle cell lipoma, angiolipoma, osteolipoma, and chondrolipoma.² Lipomas typically are subcutaneous and located over the scalp, neck, and upper trunk area but can occur anywhere on the body. They are mobile and typically well circumscribed. Lipomas have a broad base with well-demarcated swelling; fibrolipomas are usually pedunculated.

Continue to: Acrochordons ("skin tags")

Acrochordons (“skin tags”) usually contain a peduncle but may be sessile. They range from 1 mm to 1 cm in diameter and typically are located in skin folds, especially in the neck, axillae, and inguinal areas.⁶ Obesity, older age (> 50 years), and diabetes have been associated with occurrence.⁷ Acrochordons generally are smaller than fibrolipomas and often occur in multiples.

Fibrokeratomas typically are benign, solitary, fibrous tissue tumors that are found on fingers and seldom are pedunculated. They are flesh-colored and conical or nodular, with a hyperkeratotic collar. Fibrokeratomas are smaller and thicker than fibromas, as well as firm in consistency. They are acquired tumors that have been shown to be related to repetitive trauma.⁶

Treatment involves surgical excision

The preferred treatment for fibrolipoma is complete surgical excision, although cryotherapy is another option for lesions < 1 cm.⁴ Without surgical excision, the mass will continue to grow, albeit slowly.

This patient’s mass was excised successfully in its entirety; there were no complications. Follow-up is usually unnecessary.

A 30-YEAR-OLD MAN presented for evaluation of a solitary, flesh-colored, pedunculated mass on his right inner gluteal area (FIGURE) that had gradually enlarged over the previous 18 months. The lesion had manifested 4 years prior as a small papule that was stable for many years. It began to grow steadily after the patient compressed the papule forcefully. Activities of daily living, such as sitting, were now uncomfortable, so he sought treatment. He denied pain, pruritis, and bleeding and reported no history of trauma or surgery in the area of the mass.

On physical examination, the mass measured 3.5 × 4.5 cm with a 1.2-cm base. It was smooth, soft, nontender, and compressible—but nonfluctuant. There were no signs of ulceration or bleeding. No regional lymphadenopathy was noted. An excisional biopsy was performed.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

The biopsy confirmed a diagnosis of ­fibrolipoma—a rare variant of lipoma composed of a mixture of adipocytes and thick bands of fibrous connective tissues.¹ Etiology for fibrolipomas is unknown. Blunt trauma rupture of the fibrous septa that prevent fat migration may result in a proliferation of adipose tissue and thereby enlargement of fibrolipomas and other lipoma variants.² In this case, the patient’s compression of the original papule likely served as the trauma that led to its enlargement. Malignant change has not been reported with fibrolipomas.

What you’ll see—and on whom. ­Fibrolipomas typically are flesh-colored, ­pedunculated, compressible, and relatively asymp­tomatic.³ They have been reported on the face, neck, back, and pubic areas, among other locations. Size is variable; they can be as small as 1 cm in diameter and as large as 10 cm in diameter.⁴ However, fibrolipomas can grow to be “giant” if they exceed 10 cm (or 1000 g).²

The patient’s compression of the original papule likely served as the trauma that led to its enlargement.

Men and women are affected equally by fibrolipomas. Prevalence does not differ by race or ethnicity.

The differential include sother lipomas and skin tags

The differential for a mass such as this one includes lipomas, acrochordons (also known as skin tags), and fibrokeratomas.

Lipomas are the most common benign soft-tissue tumors and are composed of adipocytes.⁵ The fibrolipoma is just one variant of ­lipoma; others include the myxolipoma, myolipoma, spindle cell lipoma, angiolipoma, osteolipoma, and chondrolipoma.² Lipomas typically are subcutaneous and located over the scalp, neck, and upper trunk area but can occur anywhere on the body. They are mobile and typically well circumscribed. Lipomas have a broad base with well-demarcated swelling; fibrolipomas are usually pedunculated.

Continue to: Acrochordons ("skin tags")

Acrochordons (“skin tags”) usually contain a peduncle but may be sessile. They range from 1 mm to 1 cm in diameter and typically are located in skin folds, especially in the neck, axillae, and inguinal areas.⁶ Obesity, older age (> 50 years), and diabetes have been associated with occurrence.⁷ Acrochordons generally are smaller than fibrolipomas and often occur in multiples.

Fibrokeratomas typically are benign, solitary, fibrous tissue tumors that are found on fingers and seldom are pedunculated. They are flesh-colored and conical or nodular, with a hyperkeratotic collar. Fibrokeratomas are smaller and thicker than fibromas, as well as firm in consistency. They are acquired tumors that have been shown to be related to repetitive trauma.⁶

Treatment involves surgical excision

The preferred treatment for fibrolipoma is complete surgical excision, although cryotherapy is another option for lesions < 1 cm.⁴ Without surgical excision, the mass will continue to grow, albeit slowly.

This patient’s mass was excised successfully in its entirety; there were no complications. Follow-up is usually unnecessary.

A 30-YEAR-OLD MAN presented for evaluation of a solitary, flesh-colored, pedunculated mass on his right inner gluteal area (FIGURE) that had gradually enlarged over the previous 18 months. The lesion had manifested 4 years prior as a small papule that was stable for many years. It began to grow steadily after the patient compressed the papule forcefully. Activities of daily living, such as sitting, were now uncomfortable, so he sought treatment. He denied pain, pruritis, and bleeding and reported no history of trauma or surgery in the area of the mass.

On physical examination, the mass measured 3.5 × 4.5 cm with a 1.2-cm base. It was smooth, soft, nontender, and compressible—but nonfluctuant. There were no signs of ulceration or bleeding. No regional lymphadenopathy was noted. An excisional biopsy was performed.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

The biopsy confirmed a diagnosis of ­fibrolipoma—a rare variant of lipoma composed of a mixture of adipocytes and thick bands of fibrous connective tissues.¹ Etiology for fibrolipomas is unknown. Blunt trauma rupture of the fibrous septa that prevent fat migration may result in a proliferation of adipose tissue and thereby enlargement of fibrolipomas and other lipoma variants.² In this case, the patient’s compression of the original papule likely served as the trauma that led to its enlargement. Malignant change has not been reported with fibrolipomas.

What you’ll see—and on whom. ­Fibrolipomas typically are flesh-colored, ­pedunculated, compressible, and relatively asymp­tomatic.³ They have been reported on the face, neck, back, and pubic areas, among other locations. Size is variable; they can be as small as 1 cm in diameter and as large as 10 cm in diameter.⁴ However, fibrolipomas can grow to be “giant” if they exceed 10 cm (or 1000 g).²

The patient’s compression of the original papule likely served as the trauma that led to its enlargement.

Men and women are affected equally by fibrolipomas. Prevalence does not differ by race or ethnicity.

The differential include sother lipomas and skin tags

The differential for a mass such as this one includes lipomas, acrochordons (also known as skin tags), and fibrokeratomas.

Lipomas are the most common benign soft-tissue tumors and are composed of adipocytes.⁵ The fibrolipoma is just one variant of ­lipoma; others include the myxolipoma, myolipoma, spindle cell lipoma, angiolipoma, osteolipoma, and chondrolipoma.² Lipomas typically are subcutaneous and located over the scalp, neck, and upper trunk area but can occur anywhere on the body. They are mobile and typically well circumscribed. Lipomas have a broad base with well-demarcated swelling; fibrolipomas are usually pedunculated.

Continue to: Acrochordons ("skin tags")

Acrochordons (“skin tags”) usually contain a peduncle but may be sessile. They range from 1 mm to 1 cm in diameter and typically are located in skin folds, especially in the neck, axillae, and inguinal areas.⁶ Obesity, older age (> 50 years), and diabetes have been associated with occurrence.⁷ Acrochordons generally are smaller than fibrolipomas and often occur in multiples.

Fibrokeratomas typically are benign, solitary, fibrous tissue tumors that are found on fingers and seldom are pedunculated. They are flesh-colored and conical or nodular, with a hyperkeratotic collar. Fibrokeratomas are smaller and thicker than fibromas, as well as firm in consistency. They are acquired tumors that have been shown to be related to repetitive trauma.⁶

Treatment involves surgical excision

The preferred treatment for fibrolipoma is complete surgical excision, although cryotherapy is another option for lesions < 1 cm.⁴ Without surgical excision, the mass will continue to grow, albeit slowly.

This patient’s mass was excised successfully in its entirety; there were no complications. Follow-up is usually unnecessary.

THE COMPARISON

A A 23-year-old White woman with malar erythema from acute cutaneous lupus erythematosus. The erythema also can be seen on the nose and eyelids but spares the nasolabial folds.

B A Black woman with malar erythema and hyperpigmentation from acute cutaneous lupus erythematosus. The nasolabial folds are spared.

C A 19-year-old Latina woman with malar erythema from acute cutaneous lupus erythematosus. The erythema also can be seen on the nose, chin, and eyelids but spares the nasolabial folds. Cutaneous erosions are present on the right cheek as part of the lupus flare.

Systemic lupus erythematosus (SLE) is a chronic autoimmune condition that affects the kidneys, lungs, brain, and heart, although it is not limited to these organs. Dermatologists and primary care physicians play a critical role in the early identification of SLE (particularly in those with skin of color), as the standardized mortality rate is 2.6-fold higher in patients with SLE compared to the general population.¹ The clinical manifestations of SLE vary.

Epidemiology

A meta-analysis of data from the Centers for Disease Control and Prevention National Lupus Registry network including 5417 patients revealed a prevalence of 72.8 cases per 100,000 person-years.² The prevalence was higher in females than males and highest among females identifying as Black. White and Asian/ Pacific Islander females had the lowest prevalence. The American Indian (indigenous)/Alaska Native–identifying population had the highest race-specific SLE estimates among both females and males compared to other racial/ethnic groups.²

Key clinical features in people with darker skin tones

The diagnosis of SLE is based on clinical and immunologic criteria from the European League Against Rheumatism/American College of Rheumatology.^3,4 An antinuclear antibody titer of 1:80 or higher at least once is required for the diagnosis of SLE, as long as there is not another more likely diagnosis. If it is present, 22 additive weighted classification criteria are considered; each criterion is assigned points, ranging from 2 to 10. Patients with at least 1 clinical criterion and 10 or more points are classified as having SLE. If more than 1 of the criteria are met in a domain, then the one with the highest numerical value is counted.^3,4

Aringer et al^3,4 outline the criteria and numerical points to make the diagnosis of SLE. The mucocutaneous component of the SLE diagnostic criteria^3,4 includes nonscarring alopecia, oral ulcers, subacute cutaneous or discoid lupus erythematosus,⁵ and acute cutaneous lupus erythematosus, with acute cutaneous lupus erythematosus being the highest-weighted criterion in that domain. The other clinical domains are constitutional, hematologic, neuropsychiatric, serosal, musculoskeletal, renal, antiphospholipid antibodies, complement proteins, and SLE-specific antibodies.^3,4

The malar (“butterfly”) rash of SLE characteristically includes erythema that spares the nasolabial folds but affects the nasal bridge and cheeks.⁶ The rash occasionally may be pruritic and painful, lasting days to weeks. Photosensitivity occurs, resulting in rashes or even an overall worsening of SLE symptoms. In those with darker skin tones, erythema may appear violaceous or may not be as readily appreciated.⁶

Worth noting

• Patients with skin of color are at an increased risk for postinflammatory hypopigmentation and hyperpigmentation (pigment alteration), hypertrophic scars, and keloids.^7,8
• The mortality rate for those with SLE is high despite early recognition and treatment when compared to the general population.^1,9

Health disparity highlight

Those at greatest risk for death from SLE in the United States are those of African descent, Hispanic individuals, men, and those with low socioeconomic status,⁹ which likely is primarily driven by social determinants of health instead of genetic patterns. Income level, educational attainment, insurance status, and environmental factors¹⁰ have farreaching effects, negatively impacting quality of life and even mortality.

THE COMPARISON

A A 23-year-old White woman with malar erythema from acute cutaneous lupus erythematosus. The erythema also can be seen on the nose and eyelids but spares the nasolabial folds.

B A Black woman with malar erythema and hyperpigmentation from acute cutaneous lupus erythematosus. The nasolabial folds are spared.

C A 19-year-old Latina woman with malar erythema from acute cutaneous lupus erythematosus. The erythema also can be seen on the nose, chin, and eyelids but spares the nasolabial folds. Cutaneous erosions are present on the right cheek as part of the lupus flare.

Systemic lupus erythematosus (SLE) is a chronic autoimmune condition that affects the kidneys, lungs, brain, and heart, although it is not limited to these organs. Dermatologists and primary care physicians play a critical role in the early identification of SLE (particularly in those with skin of color), as the standardized mortality rate is 2.6-fold higher in patients with SLE compared to the general population.¹ The clinical manifestations of SLE vary.

Epidemiology

A meta-analysis of data from the Centers for Disease Control and Prevention National Lupus Registry network including 5417 patients revealed a prevalence of 72.8 cases per 100,000 person-years.² The prevalence was higher in females than males and highest among females identifying as Black. White and Asian/ Pacific Islander females had the lowest prevalence. The American Indian (indigenous)/Alaska Native–identifying population had the highest race-specific SLE estimates among both females and males compared to other racial/ethnic groups.²

Key clinical features in people with darker skin tones

The diagnosis of SLE is based on clinical and immunologic criteria from the European League Against Rheumatism/American College of Rheumatology.^3,4 An antinuclear antibody titer of 1:80 or higher at least once is required for the diagnosis of SLE, as long as there is not another more likely diagnosis. If it is present, 22 additive weighted classification criteria are considered; each criterion is assigned points, ranging from 2 to 10. Patients with at least 1 clinical criterion and 10 or more points are classified as having SLE. If more than 1 of the criteria are met in a domain, then the one with the highest numerical value is counted.^3,4

Aringer et al^3,4 outline the criteria and numerical points to make the diagnosis of SLE. The mucocutaneous component of the SLE diagnostic criteria^3,4 includes nonscarring alopecia, oral ulcers, subacute cutaneous or discoid lupus erythematosus,⁵ and acute cutaneous lupus erythematosus, with acute cutaneous lupus erythematosus being the highest-weighted criterion in that domain. The other clinical domains are constitutional, hematologic, neuropsychiatric, serosal, musculoskeletal, renal, antiphospholipid antibodies, complement proteins, and SLE-specific antibodies.^3,4

The malar (“butterfly”) rash of SLE characteristically includes erythema that spares the nasolabial folds but affects the nasal bridge and cheeks.⁶ The rash occasionally may be pruritic and painful, lasting days to weeks. Photosensitivity occurs, resulting in rashes or even an overall worsening of SLE symptoms. In those with darker skin tones, erythema may appear violaceous or may not be as readily appreciated.⁶

Worth noting

• Patients with skin of color are at an increased risk for postinflammatory hypopigmentation and hyperpigmentation (pigment alteration), hypertrophic scars, and keloids.^7,8
• The mortality rate for those with SLE is high despite early recognition and treatment when compared to the general population.^1,9

Health disparity highlight

Those at greatest risk for death from SLE in the United States are those of African descent, Hispanic individuals, men, and those with low socioeconomic status,⁹ which likely is primarily driven by social determinants of health instead of genetic patterns. Income level, educational attainment, insurance status, and environmental factors¹⁰ have farreaching effects, negatively impacting quality of life and even mortality.

THE COMPARISON

A A 23-year-old White woman with malar erythema from acute cutaneous lupus erythematosus. The erythema also can be seen on the nose and eyelids but spares the nasolabial folds.

B A Black woman with malar erythema and hyperpigmentation from acute cutaneous lupus erythematosus. The nasolabial folds are spared.

C A 19-year-old Latina woman with malar erythema from acute cutaneous lupus erythematosus. The erythema also can be seen on the nose, chin, and eyelids but spares the nasolabial folds. Cutaneous erosions are present on the right cheek as part of the lupus flare.

Systemic lupus erythematosus (SLE) is a chronic autoimmune condition that affects the kidneys, lungs, brain, and heart, although it is not limited to these organs. Dermatologists and primary care physicians play a critical role in the early identification of SLE (particularly in those with skin of color), as the standardized mortality rate is 2.6-fold higher in patients with SLE compared to the general population.¹ The clinical manifestations of SLE vary.

Epidemiology

A meta-analysis of data from the Centers for Disease Control and Prevention National Lupus Registry network including 5417 patients revealed a prevalence of 72.8 cases per 100,000 person-years.² The prevalence was higher in females than males and highest among females identifying as Black. White and Asian/ Pacific Islander females had the lowest prevalence. The American Indian (indigenous)/Alaska Native–identifying population had the highest race-specific SLE estimates among both females and males compared to other racial/ethnic groups.²

Key clinical features in people with darker skin tones

The diagnosis of SLE is based on clinical and immunologic criteria from the European League Against Rheumatism/American College of Rheumatology.^3,4 An antinuclear antibody titer of 1:80 or higher at least once is required for the diagnosis of SLE, as long as there is not another more likely diagnosis. If it is present, 22 additive weighted classification criteria are considered; each criterion is assigned points, ranging from 2 to 10. Patients with at least 1 clinical criterion and 10 or more points are classified as having SLE. If more than 1 of the criteria are met in a domain, then the one with the highest numerical value is counted.^3,4

Aringer et al^3,4 outline the criteria and numerical points to make the diagnosis of SLE. The mucocutaneous component of the SLE diagnostic criteria^3,4 includes nonscarring alopecia, oral ulcers, subacute cutaneous or discoid lupus erythematosus,⁵ and acute cutaneous lupus erythematosus, with acute cutaneous lupus erythematosus being the highest-weighted criterion in that domain. The other clinical domains are constitutional, hematologic, neuropsychiatric, serosal, musculoskeletal, renal, antiphospholipid antibodies, complement proteins, and SLE-specific antibodies.^3,4

The malar (“butterfly”) rash of SLE characteristically includes erythema that spares the nasolabial folds but affects the nasal bridge and cheeks.⁶ The rash occasionally may be pruritic and painful, lasting days to weeks. Photosensitivity occurs, resulting in rashes or even an overall worsening of SLE symptoms. In those with darker skin tones, erythema may appear violaceous or may not be as readily appreciated.⁶

Worth noting

• Patients with skin of color are at an increased risk for postinflammatory hypopigmentation and hyperpigmentation (pigment alteration), hypertrophic scars, and keloids.^7,8
• The mortality rate for those with SLE is high despite early recognition and treatment when compared to the general population.^1,9

Health disparity highlight

Those at greatest risk for death from SLE in the United States are those of African descent, Hispanic individuals, men, and those with low socioeconomic status,⁹ which likely is primarily driven by social determinants of health instead of genetic patterns. Income level, educational attainment, insurance status, and environmental factors¹⁰ have farreaching effects, negatively impacting quality of life and even mortality.

WASHINGTON – What does shared decision-making about atopic dermatitis (AD) treatment mean at a time of increasing treatment options and patient concerns about drug safety and the potentially lifelong need for systemic treatment?

The question was top of mind for experts who shared their advice during a “Tips and Tricks” session at the Revolutionizing Atopic Dermatitis meeting. Dupilumab dosing and dupilumab-associated facial redness and ocular disease, self-image issues, topical regimen adherence, and the quantification of disease were among the other topics raised by the experts.

Here are some of their practice pearls.
 

Treatment decisions, safety concerns

Deciding on a treatment is “kind of confusing ... particularly in the last year ... and it will only get more complicated,” said Raj J. Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago. “We’re all about some version of shared decision-making, but if all else is equal, sometimes it pays to explicitly ask the patient, what do you want to do?”

Questions about how long a systemic treatment should be tried, both initially and in the long run, are common. “I think that oftentimes we all get antsy about making changes when we’re not getting to the endpoint we want to. And at least in my real-world experience, late responders are a real thing. Sometimes 3-4 months ... isn’t enough,” he said.

Trial extension data show that patients who were nonresponders for various endpoints at 16 weeks are “captured continuously as you go further and further out,” Dr. Chovatiya said. Regarding the long term, “realistically, there’s no perfect time to call it quits.”

Addressing fears about Janus kinase inhibitors can be challenging, he said. “When you’ve identified the right patient and labs are done ... have them take the medication in front of you and hang out,” he advised. “It may sound ridiculous, but for the extremely anxious person it can be a big stress reducer for everyone involved.”

Regarding treatment fears more generally, “asking patients ‘what is the biggest risk of not treating your disease?’ sometimes gets people thinking,” Dr. Chovatiya said.

For parents of children with AD, said Robert Sidbury, MD, MPH, risks of not treating can become apparent once treatments are started and benefits are realized. “It’s so easy to focus on the risks of any treatment because they’re right there in black and white, and the risks of not treating are not always as apparent, even though – or maybe because – they live with them every day.”

When treatment is underway, “they see [how] everyone sleeps better, how school performance gets better, how concentration gets better,” said Dr. Sidbury, professor in the department of pediatrics at the University of Washington. Seattle, and chief of dermatology at Seattle Children’s Hospital.

“Always contextualize,” he advised. “As dermatologists, we’re savvy with navigating boxed warnings.”

David Rosmarin, MD, chair of dermatology, at Indiana University, Indianapolis, and formerly vice chair for research and education at Tufts Medical Center, Boston, said he addresses questions about the length of systemic treatment by advising patients: “Why don’t we start taking [the medication] for 3 months and then we’ll take it from there.”

In some pediatric cases, Dr. Rosmarin said, having the child express “what their AD means to them – how it affects them,” and then acknowledging and validating what the child says, is helpful to parents who are concerned about systemic treatments.
 

Dupilumab in the real world

Some patients on dupilumab do not have a complete response with dosing every 2 weeks and may benefit from more frequent dosing, said Dr. Rosmarin.

“We know from the SOLO-1 and SOLO-2 studies that dupilumab weekly dosing was evaluated. It was only the every-other-week dosing that was approved, and we can see why – in terms of the changes in EASI [Eczema Area and Severity Index] score they’re close to overlapping,” he said.

In real life, however, “some patients benefit from different dosing. It’s important to realize that. I think we all have some patients who may dose more frequently and some who may dose less frequently,” Dr. Rosmarin said.

For a patient who “gets absolutely no response from dupilumab after 3-4 months, I’d switch them to something else. But for those who are partial responders, particularly those who tell me they’re getting itchy before their next dose, they’re the ones who benefit most from doubling the dose to dupilumab weekly,” he said.

For patients who experience dupilumab-associated head and neck dermatitis, itraconazole may help, Dr. Rosmarin added. “We’re using 200 mg daily for 2 weeks and weekly thereafter, and it helps some of our patients.” The average self-reported improvement was 52% for patients with dupilumab-associated facial redness treated with itraconazole in a retrospective medical record review that he and his colleagues published in 2022.

Dr. Rosmarin pointed to a multicenter prospective cohort study also published in 2022 showing that baseline/pretreatment levels of Malassezia-specific IgE were associated with the development of dupilumab-associated head and neck dermatitis. The median levels of Malassezia-specific IgE were 32 kUL^–1 versus 2.3 kUL^–1 in patients who experienced dupilumab-associated facial redness, compared with those who did not.

He said that, while there “may be multiple reasons” for dupilumab-associated head and neck dermatitis and that “plenty of patients” who don’t have Malassezia-specific IgE develop head and neck dermatitis, “this could be one cause.”

Itraconazole has been shown in his practice to be superior to fluconazole, likely because it has greater anti-inflammatory effects and provides better coverage of Malassezia because it is more lipophilic, said Dr. Rosmarin, who does not test for Malassezia-specific IgE before trying itraconazole.

Topical adherence with diffuse xerosis and mild-moderate AD

For patients with diffuse xerosis and mild-moderate AD, especially those who are older and having difficulty with topical regimens, Anna De Benedetto, MD, said she tries to enhance adherence by simplifying the regimen. She asks patients to buy a pound jar of base cream (ceramide base) – “whatever emollient they like” – and mixes into it a high-potency steroid solution. They’re instructed to apply the combined cream once daily for 1-2 weeks, and then three times a week alternating with a nonmedicated cream.

“This way they’re using one [cream] to target the immune system and the skin barrier,” said Dr. De Benedetto, associate professor of dermatology and director of the dermatology clinical trial unit at the University of Rochester (N.Y.) Medical Center.
 

‘Wet wrap’ pajamas; self-image for children, teens

Dermatologist Melinda Gooderham, MSc, MD, assistant professor at Queen’s University, Kingston, Ont., and medical director at the SKiN Centre for Dermatology, said that, for widespread and troublesome AD, she advises patients or parents to wet a thin cotton pajama top and bottom and spin it in the dryer “so it’s almost dry but still moist.” Dry, looser pajamas or a light track suit can then be worn over the damp pajamas. “I usually tell [patients] to buy one size up,” she said.

Bruce Jancin/Frontline Medical News

Body dysmorphia is common with skin disease, and its incidence is six times higher in people with eczema than those without the disease, said Dr. Siegfried. “I’ve found that, for patients subjected to AD for a long time,” this is still an issue, “even when you clear their skin.”

For children, teens and their families, the nonprofit organization Made a Masterpiece can be valuable, Dr. Siegfried said. It offers resources from parents, children, psychologists, dermatologists, and others to help manage the emotional, social and spiritual aspects of living with a skin condition.
 

To use or not to use BSA; environmental counseling

“I think [assessing] body surface area [BSA] is very important in pediatrics and for adolescents [especially in those with moderate to severe disease] because it quantifies the disease for the family,” said Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics and vice chair of the department of dermatology at the University of California, San Diego.

University of California, San Diego

“Families live with the disease, but quantification really matters” for understanding the extent and impact of the disease and for motivating families to treat, said Dr. Eichenfield.

(When the disease is markedly diminished in follow-up, knowing the BSA then “helps families to register the improvement and gives positive reinforcement,” Dr. Eichenfeld said after the meeting.)

Young patients can participate, he noted at the meeting. “When I do telemedicine visits, kids can tell me how many hands of eczema they have.”

Dr. Eichenfield also said that he now routinely counsels on the environmental impacts on eczema. For example, “I explain to people that we’re probably going to have a bad wildfire season in California, and it’s the kind of environmental perturbation that may impact some eczema patients,” he said, noting the 2021 study documenting an association of wildfire air pollution from the 2018 California Camp fire with an increase in dermatology clinic visits for AD and itch in San Francisco.

“It helps to keep an eye out for that, and also to be aware of some of the environmental changes,” he said.

Dr. Chovatiya reported ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi, among others. Dr. Sidbury reported ties with Regeneron, UCB, Pfizer, Leo Pharma, and Lilly, among others. Dr. Rosmarin reported ties with AbbVie, Incyte, Lilly, Pfizer, Regeneron, and Sanofi, among others. Dr. Siegfried reported ties with Regeneron, Sanofi Genzyme, AbbVie, Incyte, Leo, and Pfizer, among others. Dr. De Benedetto reported ties with Incyte, Pfizer, AbbVie, and Sanofi Advent, among others. Dr. Gooderham reported ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, among others. Dr. Eichenfield disclosed ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi, among others.

WASHINGTON – What does shared decision-making about atopic dermatitis (AD) treatment mean at a time of increasing treatment options and patient concerns about drug safety and the potentially lifelong need for systemic treatment?

The question was top of mind for experts who shared their advice during a “Tips and Tricks” session at the Revolutionizing Atopic Dermatitis meeting. Dupilumab dosing and dupilumab-associated facial redness and ocular disease, self-image issues, topical regimen adherence, and the quantification of disease were among the other topics raised by the experts.

Here are some of their practice pearls.
 

Treatment decisions, safety concerns

Deciding on a treatment is “kind of confusing ... particularly in the last year ... and it will only get more complicated,” said Raj J. Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago. “We’re all about some version of shared decision-making, but if all else is equal, sometimes it pays to explicitly ask the patient, what do you want to do?”

Questions about how long a systemic treatment should be tried, both initially and in the long run, are common. “I think that oftentimes we all get antsy about making changes when we’re not getting to the endpoint we want to. And at least in my real-world experience, late responders are a real thing. Sometimes 3-4 months ... isn’t enough,” he said.

Trial extension data show that patients who were nonresponders for various endpoints at 16 weeks are “captured continuously as you go further and further out,” Dr. Chovatiya said. Regarding the long term, “realistically, there’s no perfect time to call it quits.”

Addressing fears about Janus kinase inhibitors can be challenging, he said. “When you’ve identified the right patient and labs are done ... have them take the medication in front of you and hang out,” he advised. “It may sound ridiculous, but for the extremely anxious person it can be a big stress reducer for everyone involved.”

Regarding treatment fears more generally, “asking patients ‘what is the biggest risk of not treating your disease?’ sometimes gets people thinking,” Dr. Chovatiya said.

For parents of children with AD, said Robert Sidbury, MD, MPH, risks of not treating can become apparent once treatments are started and benefits are realized. “It’s so easy to focus on the risks of any treatment because they’re right there in black and white, and the risks of not treating are not always as apparent, even though – or maybe because – they live with them every day.”

When treatment is underway, “they see [how] everyone sleeps better, how school performance gets better, how concentration gets better,” said Dr. Sidbury, professor in the department of pediatrics at the University of Washington. Seattle, and chief of dermatology at Seattle Children’s Hospital.

“Always contextualize,” he advised. “As dermatologists, we’re savvy with navigating boxed warnings.”

David Rosmarin, MD, chair of dermatology, at Indiana University, Indianapolis, and formerly vice chair for research and education at Tufts Medical Center, Boston, said he addresses questions about the length of systemic treatment by advising patients: “Why don’t we start taking [the medication] for 3 months and then we’ll take it from there.”

In some pediatric cases, Dr. Rosmarin said, having the child express “what their AD means to them – how it affects them,” and then acknowledging and validating what the child says, is helpful to parents who are concerned about systemic treatments.
 

Dupilumab in the real world

Some patients on dupilumab do not have a complete response with dosing every 2 weeks and may benefit from more frequent dosing, said Dr. Rosmarin.

“We know from the SOLO-1 and SOLO-2 studies that dupilumab weekly dosing was evaluated. It was only the every-other-week dosing that was approved, and we can see why – in terms of the changes in EASI [Eczema Area and Severity Index] score they’re close to overlapping,” he said.

In real life, however, “some patients benefit from different dosing. It’s important to realize that. I think we all have some patients who may dose more frequently and some who may dose less frequently,” Dr. Rosmarin said.

For a patient who “gets absolutely no response from dupilumab after 3-4 months, I’d switch them to something else. But for those who are partial responders, particularly those who tell me they’re getting itchy before their next dose, they’re the ones who benefit most from doubling the dose to dupilumab weekly,” he said.

For patients who experience dupilumab-associated head and neck dermatitis, itraconazole may help, Dr. Rosmarin added. “We’re using 200 mg daily for 2 weeks and weekly thereafter, and it helps some of our patients.” The average self-reported improvement was 52% for patients with dupilumab-associated facial redness treated with itraconazole in a retrospective medical record review that he and his colleagues published in 2022.

Dr. Rosmarin pointed to a multicenter prospective cohort study also published in 2022 showing that baseline/pretreatment levels of Malassezia-specific IgE were associated with the development of dupilumab-associated head and neck dermatitis. The median levels of Malassezia-specific IgE were 32 kUL^–1 versus 2.3 kUL^–1 in patients who experienced dupilumab-associated facial redness, compared with those who did not.

He said that, while there “may be multiple reasons” for dupilumab-associated head and neck dermatitis and that “plenty of patients” who don’t have Malassezia-specific IgE develop head and neck dermatitis, “this could be one cause.”

Itraconazole has been shown in his practice to be superior to fluconazole, likely because it has greater anti-inflammatory effects and provides better coverage of Malassezia because it is more lipophilic, said Dr. Rosmarin, who does not test for Malassezia-specific IgE before trying itraconazole.

Topical adherence with diffuse xerosis and mild-moderate AD

For patients with diffuse xerosis and mild-moderate AD, especially those who are older and having difficulty with topical regimens, Anna De Benedetto, MD, said she tries to enhance adherence by simplifying the regimen. She asks patients to buy a pound jar of base cream (ceramide base) – “whatever emollient they like” – and mixes into it a high-potency steroid solution. They’re instructed to apply the combined cream once daily for 1-2 weeks, and then three times a week alternating with a nonmedicated cream.

“This way they’re using one [cream] to target the immune system and the skin barrier,” said Dr. De Benedetto, associate professor of dermatology and director of the dermatology clinical trial unit at the University of Rochester (N.Y.) Medical Center.
 

‘Wet wrap’ pajamas; self-image for children, teens

Dermatologist Melinda Gooderham, MSc, MD, assistant professor at Queen’s University, Kingston, Ont., and medical director at the SKiN Centre for Dermatology, said that, for widespread and troublesome AD, she advises patients or parents to wet a thin cotton pajama top and bottom and spin it in the dryer “so it’s almost dry but still moist.” Dry, looser pajamas or a light track suit can then be worn over the damp pajamas. “I usually tell [patients] to buy one size up,” she said.

Bruce Jancin/Frontline Medical News

Body dysmorphia is common with skin disease, and its incidence is six times higher in people with eczema than those without the disease, said Dr. Siegfried. “I’ve found that, for patients subjected to AD for a long time,” this is still an issue, “even when you clear their skin.”

For children, teens and their families, the nonprofit organization Made a Masterpiece can be valuable, Dr. Siegfried said. It offers resources from parents, children, psychologists, dermatologists, and others to help manage the emotional, social and spiritual aspects of living with a skin condition.
 

To use or not to use BSA; environmental counseling

“I think [assessing] body surface area [BSA] is very important in pediatrics and for adolescents [especially in those with moderate to severe disease] because it quantifies the disease for the family,” said Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics and vice chair of the department of dermatology at the University of California, San Diego.

University of California, San Diego

“Families live with the disease, but quantification really matters” for understanding the extent and impact of the disease and for motivating families to treat, said Dr. Eichenfield.

(When the disease is markedly diminished in follow-up, knowing the BSA then “helps families to register the improvement and gives positive reinforcement,” Dr. Eichenfeld said after the meeting.)

Young patients can participate, he noted at the meeting. “When I do telemedicine visits, kids can tell me how many hands of eczema they have.”

Dr. Eichenfield also said that he now routinely counsels on the environmental impacts on eczema. For example, “I explain to people that we’re probably going to have a bad wildfire season in California, and it’s the kind of environmental perturbation that may impact some eczema patients,” he said, noting the 2021 study documenting an association of wildfire air pollution from the 2018 California Camp fire with an increase in dermatology clinic visits for AD and itch in San Francisco.

“It helps to keep an eye out for that, and also to be aware of some of the environmental changes,” he said.

Dr. Chovatiya reported ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi, among others. Dr. Sidbury reported ties with Regeneron, UCB, Pfizer, Leo Pharma, and Lilly, among others. Dr. Rosmarin reported ties with AbbVie, Incyte, Lilly, Pfizer, Regeneron, and Sanofi, among others. Dr. Siegfried reported ties with Regeneron, Sanofi Genzyme, AbbVie, Incyte, Leo, and Pfizer, among others. Dr. De Benedetto reported ties with Incyte, Pfizer, AbbVie, and Sanofi Advent, among others. Dr. Gooderham reported ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, among others. Dr. Eichenfield disclosed ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi, among others.

WASHINGTON – What does shared decision-making about atopic dermatitis (AD) treatment mean at a time of increasing treatment options and patient concerns about drug safety and the potentially lifelong need for systemic treatment?

The question was top of mind for experts who shared their advice during a “Tips and Tricks” session at the Revolutionizing Atopic Dermatitis meeting. Dupilumab dosing and dupilumab-associated facial redness and ocular disease, self-image issues, topical regimen adherence, and the quantification of disease were among the other topics raised by the experts.

Here are some of their practice pearls.
 

Treatment decisions, safety concerns

Deciding on a treatment is “kind of confusing ... particularly in the last year ... and it will only get more complicated,” said Raj J. Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago. “We’re all about some version of shared decision-making, but if all else is equal, sometimes it pays to explicitly ask the patient, what do you want to do?”

Questions about how long a systemic treatment should be tried, both initially and in the long run, are common. “I think that oftentimes we all get antsy about making changes when we’re not getting to the endpoint we want to. And at least in my real-world experience, late responders are a real thing. Sometimes 3-4 months ... isn’t enough,” he said.

Trial extension data show that patients who were nonresponders for various endpoints at 16 weeks are “captured continuously as you go further and further out,” Dr. Chovatiya said. Regarding the long term, “realistically, there’s no perfect time to call it quits.”

Addressing fears about Janus kinase inhibitors can be challenging, he said. “When you’ve identified the right patient and labs are done ... have them take the medication in front of you and hang out,” he advised. “It may sound ridiculous, but for the extremely anxious person it can be a big stress reducer for everyone involved.”

Regarding treatment fears more generally, “asking patients ‘what is the biggest risk of not treating your disease?’ sometimes gets people thinking,” Dr. Chovatiya said.

For parents of children with AD, said Robert Sidbury, MD, MPH, risks of not treating can become apparent once treatments are started and benefits are realized. “It’s so easy to focus on the risks of any treatment because they’re right there in black and white, and the risks of not treating are not always as apparent, even though – or maybe because – they live with them every day.”

When treatment is underway, “they see [how] everyone sleeps better, how school performance gets better, how concentration gets better,” said Dr. Sidbury, professor in the department of pediatrics at the University of Washington. Seattle, and chief of dermatology at Seattle Children’s Hospital.

“Always contextualize,” he advised. “As dermatologists, we’re savvy with navigating boxed warnings.”

David Rosmarin, MD, chair of dermatology, at Indiana University, Indianapolis, and formerly vice chair for research and education at Tufts Medical Center, Boston, said he addresses questions about the length of systemic treatment by advising patients: “Why don’t we start taking [the medication] for 3 months and then we’ll take it from there.”

In some pediatric cases, Dr. Rosmarin said, having the child express “what their AD means to them – how it affects them,” and then acknowledging and validating what the child says, is helpful to parents who are concerned about systemic treatments.
 

Dupilumab in the real world

Some patients on dupilumab do not have a complete response with dosing every 2 weeks and may benefit from more frequent dosing, said Dr. Rosmarin.

“We know from the SOLO-1 and SOLO-2 studies that dupilumab weekly dosing was evaluated. It was only the every-other-week dosing that was approved, and we can see why – in terms of the changes in EASI [Eczema Area and Severity Index] score they’re close to overlapping,” he said.

In real life, however, “some patients benefit from different dosing. It’s important to realize that. I think we all have some patients who may dose more frequently and some who may dose less frequently,” Dr. Rosmarin said.

For a patient who “gets absolutely no response from dupilumab after 3-4 months, I’d switch them to something else. But for those who are partial responders, particularly those who tell me they’re getting itchy before their next dose, they’re the ones who benefit most from doubling the dose to dupilumab weekly,” he said.

For patients who experience dupilumab-associated head and neck dermatitis, itraconazole may help, Dr. Rosmarin added. “We’re using 200 mg daily for 2 weeks and weekly thereafter, and it helps some of our patients.” The average self-reported improvement was 52% for patients with dupilumab-associated facial redness treated with itraconazole in a retrospective medical record review that he and his colleagues published in 2022.

Dr. Rosmarin pointed to a multicenter prospective cohort study also published in 2022 showing that baseline/pretreatment levels of Malassezia-specific IgE were associated with the development of dupilumab-associated head and neck dermatitis. The median levels of Malassezia-specific IgE were 32 kUL^–1 versus 2.3 kUL^–1 in patients who experienced dupilumab-associated facial redness, compared with those who did not.

He said that, while there “may be multiple reasons” for dupilumab-associated head and neck dermatitis and that “plenty of patients” who don’t have Malassezia-specific IgE develop head and neck dermatitis, “this could be one cause.”

Itraconazole has been shown in his practice to be superior to fluconazole, likely because it has greater anti-inflammatory effects and provides better coverage of Malassezia because it is more lipophilic, said Dr. Rosmarin, who does not test for Malassezia-specific IgE before trying itraconazole.

Topical adherence with diffuse xerosis and mild-moderate AD

For patients with diffuse xerosis and mild-moderate AD, especially those who are older and having difficulty with topical regimens, Anna De Benedetto, MD, said she tries to enhance adherence by simplifying the regimen. She asks patients to buy a pound jar of base cream (ceramide base) – “whatever emollient they like” – and mixes into it a high-potency steroid solution. They’re instructed to apply the combined cream once daily for 1-2 weeks, and then three times a week alternating with a nonmedicated cream.

“This way they’re using one [cream] to target the immune system and the skin barrier,” said Dr. De Benedetto, associate professor of dermatology and director of the dermatology clinical trial unit at the University of Rochester (N.Y.) Medical Center.
 

‘Wet wrap’ pajamas; self-image for children, teens

Dermatologist Melinda Gooderham, MSc, MD, assistant professor at Queen’s University, Kingston, Ont., and medical director at the SKiN Centre for Dermatology, said that, for widespread and troublesome AD, she advises patients or parents to wet a thin cotton pajama top and bottom and spin it in the dryer “so it’s almost dry but still moist.” Dry, looser pajamas or a light track suit can then be worn over the damp pajamas. “I usually tell [patients] to buy one size up,” she said.

Bruce Jancin/Frontline Medical News

Body dysmorphia is common with skin disease, and its incidence is six times higher in people with eczema than those without the disease, said Dr. Siegfried. “I’ve found that, for patients subjected to AD for a long time,” this is still an issue, “even when you clear their skin.”

For children, teens and their families, the nonprofit organization Made a Masterpiece can be valuable, Dr. Siegfried said. It offers resources from parents, children, psychologists, dermatologists, and others to help manage the emotional, social and spiritual aspects of living with a skin condition.
 

To use or not to use BSA; environmental counseling

“I think [assessing] body surface area [BSA] is very important in pediatrics and for adolescents [especially in those with moderate to severe disease] because it quantifies the disease for the family,” said Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics and vice chair of the department of dermatology at the University of California, San Diego.

University of California, San Diego

“Families live with the disease, but quantification really matters” for understanding the extent and impact of the disease and for motivating families to treat, said Dr. Eichenfield.

(When the disease is markedly diminished in follow-up, knowing the BSA then “helps families to register the improvement and gives positive reinforcement,” Dr. Eichenfeld said after the meeting.)

Young patients can participate, he noted at the meeting. “When I do telemedicine visits, kids can tell me how many hands of eczema they have.”

Dr. Eichenfield also said that he now routinely counsels on the environmental impacts on eczema. For example, “I explain to people that we’re probably going to have a bad wildfire season in California, and it’s the kind of environmental perturbation that may impact some eczema patients,” he said, noting the 2021 study documenting an association of wildfire air pollution from the 2018 California Camp fire with an increase in dermatology clinic visits for AD and itch in San Francisco.

“It helps to keep an eye out for that, and also to be aware of some of the environmental changes,” he said.

Dr. Chovatiya reported ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi, among others. Dr. Sidbury reported ties with Regeneron, UCB, Pfizer, Leo Pharma, and Lilly, among others. Dr. Rosmarin reported ties with AbbVie, Incyte, Lilly, Pfizer, Regeneron, and Sanofi, among others. Dr. Siegfried reported ties with Regeneron, Sanofi Genzyme, AbbVie, Incyte, Leo, and Pfizer, among others. Dr. De Benedetto reported ties with Incyte, Pfizer, AbbVie, and Sanofi Advent, among others. Dr. Gooderham reported ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, among others. Dr. Eichenfield disclosed ties with AbbVie, Eli Lilly, Incyte, Leo Pharma, Pfizer, Regeneron, and Sanofi, among others.