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Insurers’ Rules and AI for Preauthorization: ‘Ethically Nuts,’ Says Ethicist

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Changed
Thu, 08/01/2024 - 12:24

This transcript has been edited for clarity

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City. 

There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.

I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.

Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. We’re not getting a neutral review by third parties of the appropriateness of treatment recommendations or somebody saying, this is the standard of care and this is what ought to happen.

We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine. 

We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.

We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.

If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review? 

Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.

Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.

This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.

There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.

This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.

I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.

Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.

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

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This transcript has been edited for clarity

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City. 

There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.

I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.

Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. We’re not getting a neutral review by third parties of the appropriateness of treatment recommendations or somebody saying, this is the standard of care and this is what ought to happen.

We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine. 

We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.

We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.

If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review? 

Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.

Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.

This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.

There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.

This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.

I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.

Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.

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

This transcript has been edited for clarity

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City. 

There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.

I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.

Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. We’re not getting a neutral review by third parties of the appropriateness of treatment recommendations or somebody saying, this is the standard of care and this is what ought to happen.

We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine. 

We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.

We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.

If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review? 

Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.

Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.

This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.

There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.

This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.

I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.

Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.

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

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Lipedema: Current Diagnostic and Treatment Evidence

Article Type
Changed
Thu, 08/01/2024 - 12:19

Lipedema affects about 11% of cisgender women, according to the Brazilian Society of Angiology and Vascular Surgery. Yet the condition remains wrapped in uncertainties. Despite significant advancements in understanding its physiology, diagnosis, and treatment, more clarity is needed as awareness and diagnoses increase.

At the latest International Congress on Obesity (ICO) in São Paulo, Brazil, Philipp Scherer, PhD, director of the Touchstone Diabetes Center, discussed the complexities of lipedema. “It is an extremely frustrating condition for someone like me, who has spent a lifetime studying functional and dysfunctional adipose tissue. We are trying to understand the physiology of this pathology, but it is challenging, and so far, we have not been able to find a concrete answer,” he noted.

Lipedema is characterized by the abnormal accumulation of subcutaneous adipose tissue, especially in the lower limbs, and almost exclusively affects cisgender women. The reason for this gender disparity is unclear. It could be an intrinsic characteristic of the disease or a result from clinicians’ lack of familiarity with lipedema, which often leads to misdiagnosis as obesity. This misdiagnosis results in fewer men seeking treatment.

Research has predominantly focused on women, and evidence suggests that hormones play a crucial role in the disease’s pathophysiology. Lipedema typically manifests during periods of hormonal changes, such as puberty, pregnancy, menopause, and hormone replacement therapies, reinforcing the idea that hormones significantly influence the condition’s development and progression.
 

Main Symptoms

Jonathan Kartt, CEO of the Lipedema Foundation, emphasized that intense pain in the areas of adipose tissue accumulation is a hallmark symptom of lipedema, setting it apart from obesity. Pain levels can vary widely among patients, ranging from moderate to severe, with unbearable peaks on certain days. Mr. Kartt stressed the importance of recognizing and addressing this often underestimated symptom.

Lipedema is characterized by a bilateral, symmetrical increase in mass compared with the rest of the body. This is commonly distinguished by the “cuff sign,” a separation between normal tissue in the feet and abnormal tissue from the ankle upward. Other frequent symptoms include a feeling of heaviness, discomfort, fatigue, frequent bruising, and tiredness. A notable sign is the presence of subcutaneous nodules with a texture similar to that of rice grains, which are crucial for differentiating lipedema from other conditions. Palpation during anamnesis is essential to identify these nodules and confirm the diagnosis.

“It is crucial to investigate the family history for genetic predisposition. Additionally, it is fundamental to ask whether, even with weight loss, the affected areas retain accumulated fat. Hormonal changes, pain symptoms, and impact on quality of life should also be carefully evaluated,” advised Mr. Kartt.
 

Diagnostic Tools

André Murad, MD, a clinical consultant at the Instituto Lipedema Brazil, has been exploring new diagnostic approaches for lipedema beyond traditional anamnesis. During his presentation at the ICO, he shared studies on the efficacy of imaging exams such as ultrasound, tomography, and MRI in diagnosing the characteristic lipedema-associated increase in subcutaneous tissue.

He also discussed lymphangiography and lymphoscintigraphy, highlighting the use of magnetic resonance lymphangiography to evaluate dilated lymphatic vessels often observed in patients with lipedema. “By injecting contrast into the feet, this technique allows the evaluation of vessels, which are usually dilated, indicating characteristic lymphatic system overload in lipedema. Lymphoscintigraphy is crucial for detecting associated lymphedema, revealing delayed lymphatic flow and asymmetry between limbs in cases of lipedema without lymphedema,” he explained.

Despite the various diagnostic options, Dr. Murad highlighted two highly effective studies. A Brazilian study used ultrasound to establish a cutoff point of 11.7 mm in the pretibial subcutaneous tissue thickness, achieving 96% specificity for diagnosis. Another study emphasized the value of dual-energy x-ray absorptiometry (DXA), which demonstrated 95% sensitivity. This method assesses fat distribution by correlating the amount present in the legs with the total body, providing a cost-effective and accessible option for specialists.

“DXA allows for a precise mathematical evaluation of fat distribution relative to the total body. A ratio of 0.38 in the leg-to-body relationship is a significant indicator of high suspicion of lipedema,” highlighted Dr. Murad. “In clinical practice, many patients self-diagnose with lipedema, but the clinical exam often reveals no disproportion, with the leg-to-body ratio below 0.38 being common in these cases,” he added.
 

 

 

Treatment Approaches

Treatments for lipedema are still evolving, with considerable debate about the best approach. While some specialists advocate exclusively for conservative treatment, others recommend combining these methods with surgical interventions, depending on the stage of the disease. The relative novelty of lipedema and the scarcity of robust, long-term studies contribute to the uncertainty around treatment efficacy.

Conservative treatment typically includes compression, lymphatic drainage techniques, and pressure therapy. An active lifestyle and a healthy diet are also recommended. Although these measures do not prevent the accumulation of adipose tissue, they help reduce inflammation and improve quality of life. “Even though the causes of lipedema are not fully known, lifestyle management is essential for controlling symptoms, starting with an anti-inflammatory diet,” emphasized Dr. Murad.

Because insulin promotes lipogenesis, a diet that avoids spikes in glycemic and insulin levels is advisable. Insulin resistance can exacerbate edema formation, so a Mediterranean diet may be beneficial. This diet limits fast-absorbing carbohydrates, such as added sugar, refined grains, and ultraprocessed foods, while promoting complex carbohydrates from whole grains and legumes.

Dr. Murad also presented a study evaluating the potential benefits of a low-carbohydrate, high-fat diet for patients with lipedema. The study demonstrated weight loss, reduced body fat, controlled leg volume, and, notably, pain relief.

For more advanced stages of lipedema, plastic surgery is often considered when conservative approaches do not yield satisfactory results. Some specialists advocate for surgery as an effective way to remove diseased adipose cells and reduce excess fat accumulation, which can improve physical appearance and associated pain. There is a growing consensus that surgical intervention should be performed early, ideally in stage I of IV, to maximize efficacy and prevent disease progression.

Fábio Masato Kamamoto, MD, a plastic surgeon and director of the Instituto Lipedema Brazil, shared insights into surgical treatments for lipedema. He discussed techniques from liposuction to advanced skin retraction and dermolipectomy, crucial for addressing more advanced stages of the condition. “It’s a complex process that demands precision to protect the lymphatic system, especially considering the characteristic nodules of lipedema,” he noted.

Dr. Kamamoto discussed a former patient with stage III lipedema. In the initial stage, he performed liposuction, removing 8 L of fat and 3.4 kg of skin. After 6 months, a follow-up procedure resulted in a total removal of 15 kg. Complementary procedures, such as microneedling, were performed to stimulate collagen production and reduce skin sagging. In addition to cosmetic improvements, the procedure also removed the distinctive lipedema nodules, which Mr. Kartt described as feeling like “rice grains.” Removing these nodules significantly alleviates pain, according to Dr. Kamamoto.

The benefits of surgical treatment for lipedema can be long lasting. Dr. Kamamoto noted that fat tends not to reaccumulate in treated areas, with patients often experiencing lower weight, reduced edema, and decreased pain over time. “While we hope that patients do not regain weight, the benefits of surgery persist even if weight is regained. Therefore, combining conservative and surgical treatments remains a valid and effective approach,” he concluded.

Dr. Scherer highlighted that despite various approaches, there is still no definitive “magic signature” that fully explains lipedema. This lack of clarity directly affects the effectiveness of diagnoses and treatments. He expressed hope that future integration of data from different studies and approaches will lead to the identification of a clinically useful molecular signature. “The true cause of lipedema remains unknown, requiring more speculation, hypothesis formulation, and testing for significant discoveries. This situation is frustrating, as the disease affects many women who lack a clear diagnosis that differentiates them from patients with obesity, as well as evidence-based recommendations,” he concluded.
 

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Lipedema affects about 11% of cisgender women, according to the Brazilian Society of Angiology and Vascular Surgery. Yet the condition remains wrapped in uncertainties. Despite significant advancements in understanding its physiology, diagnosis, and treatment, more clarity is needed as awareness and diagnoses increase.

At the latest International Congress on Obesity (ICO) in São Paulo, Brazil, Philipp Scherer, PhD, director of the Touchstone Diabetes Center, discussed the complexities of lipedema. “It is an extremely frustrating condition for someone like me, who has spent a lifetime studying functional and dysfunctional adipose tissue. We are trying to understand the physiology of this pathology, but it is challenging, and so far, we have not been able to find a concrete answer,” he noted.

Lipedema is characterized by the abnormal accumulation of subcutaneous adipose tissue, especially in the lower limbs, and almost exclusively affects cisgender women. The reason for this gender disparity is unclear. It could be an intrinsic characteristic of the disease or a result from clinicians’ lack of familiarity with lipedema, which often leads to misdiagnosis as obesity. This misdiagnosis results in fewer men seeking treatment.

Research has predominantly focused on women, and evidence suggests that hormones play a crucial role in the disease’s pathophysiology. Lipedema typically manifests during periods of hormonal changes, such as puberty, pregnancy, menopause, and hormone replacement therapies, reinforcing the idea that hormones significantly influence the condition’s development and progression.
 

Main Symptoms

Jonathan Kartt, CEO of the Lipedema Foundation, emphasized that intense pain in the areas of adipose tissue accumulation is a hallmark symptom of lipedema, setting it apart from obesity. Pain levels can vary widely among patients, ranging from moderate to severe, with unbearable peaks on certain days. Mr. Kartt stressed the importance of recognizing and addressing this often underestimated symptom.

Lipedema is characterized by a bilateral, symmetrical increase in mass compared with the rest of the body. This is commonly distinguished by the “cuff sign,” a separation between normal tissue in the feet and abnormal tissue from the ankle upward. Other frequent symptoms include a feeling of heaviness, discomfort, fatigue, frequent bruising, and tiredness. A notable sign is the presence of subcutaneous nodules with a texture similar to that of rice grains, which are crucial for differentiating lipedema from other conditions. Palpation during anamnesis is essential to identify these nodules and confirm the diagnosis.

“It is crucial to investigate the family history for genetic predisposition. Additionally, it is fundamental to ask whether, even with weight loss, the affected areas retain accumulated fat. Hormonal changes, pain symptoms, and impact on quality of life should also be carefully evaluated,” advised Mr. Kartt.
 

Diagnostic Tools

André Murad, MD, a clinical consultant at the Instituto Lipedema Brazil, has been exploring new diagnostic approaches for lipedema beyond traditional anamnesis. During his presentation at the ICO, he shared studies on the efficacy of imaging exams such as ultrasound, tomography, and MRI in diagnosing the characteristic lipedema-associated increase in subcutaneous tissue.

He also discussed lymphangiography and lymphoscintigraphy, highlighting the use of magnetic resonance lymphangiography to evaluate dilated lymphatic vessels often observed in patients with lipedema. “By injecting contrast into the feet, this technique allows the evaluation of vessels, which are usually dilated, indicating characteristic lymphatic system overload in lipedema. Lymphoscintigraphy is crucial for detecting associated lymphedema, revealing delayed lymphatic flow and asymmetry between limbs in cases of lipedema without lymphedema,” he explained.

Despite the various diagnostic options, Dr. Murad highlighted two highly effective studies. A Brazilian study used ultrasound to establish a cutoff point of 11.7 mm in the pretibial subcutaneous tissue thickness, achieving 96% specificity for diagnosis. Another study emphasized the value of dual-energy x-ray absorptiometry (DXA), which demonstrated 95% sensitivity. This method assesses fat distribution by correlating the amount present in the legs with the total body, providing a cost-effective and accessible option for specialists.

“DXA allows for a precise mathematical evaluation of fat distribution relative to the total body. A ratio of 0.38 in the leg-to-body relationship is a significant indicator of high suspicion of lipedema,” highlighted Dr. Murad. “In clinical practice, many patients self-diagnose with lipedema, but the clinical exam often reveals no disproportion, with the leg-to-body ratio below 0.38 being common in these cases,” he added.
 

 

 

Treatment Approaches

Treatments for lipedema are still evolving, with considerable debate about the best approach. While some specialists advocate exclusively for conservative treatment, others recommend combining these methods with surgical interventions, depending on the stage of the disease. The relative novelty of lipedema and the scarcity of robust, long-term studies contribute to the uncertainty around treatment efficacy.

Conservative treatment typically includes compression, lymphatic drainage techniques, and pressure therapy. An active lifestyle and a healthy diet are also recommended. Although these measures do not prevent the accumulation of adipose tissue, they help reduce inflammation and improve quality of life. “Even though the causes of lipedema are not fully known, lifestyle management is essential for controlling symptoms, starting with an anti-inflammatory diet,” emphasized Dr. Murad.

Because insulin promotes lipogenesis, a diet that avoids spikes in glycemic and insulin levels is advisable. Insulin resistance can exacerbate edema formation, so a Mediterranean diet may be beneficial. This diet limits fast-absorbing carbohydrates, such as added sugar, refined grains, and ultraprocessed foods, while promoting complex carbohydrates from whole grains and legumes.

Dr. Murad also presented a study evaluating the potential benefits of a low-carbohydrate, high-fat diet for patients with lipedema. The study demonstrated weight loss, reduced body fat, controlled leg volume, and, notably, pain relief.

For more advanced stages of lipedema, plastic surgery is often considered when conservative approaches do not yield satisfactory results. Some specialists advocate for surgery as an effective way to remove diseased adipose cells and reduce excess fat accumulation, which can improve physical appearance and associated pain. There is a growing consensus that surgical intervention should be performed early, ideally in stage I of IV, to maximize efficacy and prevent disease progression.

Fábio Masato Kamamoto, MD, a plastic surgeon and director of the Instituto Lipedema Brazil, shared insights into surgical treatments for lipedema. He discussed techniques from liposuction to advanced skin retraction and dermolipectomy, crucial for addressing more advanced stages of the condition. “It’s a complex process that demands precision to protect the lymphatic system, especially considering the characteristic nodules of lipedema,” he noted.

Dr. Kamamoto discussed a former patient with stage III lipedema. In the initial stage, he performed liposuction, removing 8 L of fat and 3.4 kg of skin. After 6 months, a follow-up procedure resulted in a total removal of 15 kg. Complementary procedures, such as microneedling, were performed to stimulate collagen production and reduce skin sagging. In addition to cosmetic improvements, the procedure also removed the distinctive lipedema nodules, which Mr. Kartt described as feeling like “rice grains.” Removing these nodules significantly alleviates pain, according to Dr. Kamamoto.

The benefits of surgical treatment for lipedema can be long lasting. Dr. Kamamoto noted that fat tends not to reaccumulate in treated areas, with patients often experiencing lower weight, reduced edema, and decreased pain over time. “While we hope that patients do not regain weight, the benefits of surgery persist even if weight is regained. Therefore, combining conservative and surgical treatments remains a valid and effective approach,” he concluded.

Dr. Scherer highlighted that despite various approaches, there is still no definitive “magic signature” that fully explains lipedema. This lack of clarity directly affects the effectiveness of diagnoses and treatments. He expressed hope that future integration of data from different studies and approaches will lead to the identification of a clinically useful molecular signature. “The true cause of lipedema remains unknown, requiring more speculation, hypothesis formulation, and testing for significant discoveries. This situation is frustrating, as the disease affects many women who lack a clear diagnosis that differentiates them from patients with obesity, as well as evidence-based recommendations,” he concluded.
 

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Lipedema affects about 11% of cisgender women, according to the Brazilian Society of Angiology and Vascular Surgery. Yet the condition remains wrapped in uncertainties. Despite significant advancements in understanding its physiology, diagnosis, and treatment, more clarity is needed as awareness and diagnoses increase.

At the latest International Congress on Obesity (ICO) in São Paulo, Brazil, Philipp Scherer, PhD, director of the Touchstone Diabetes Center, discussed the complexities of lipedema. “It is an extremely frustrating condition for someone like me, who has spent a lifetime studying functional and dysfunctional adipose tissue. We are trying to understand the physiology of this pathology, but it is challenging, and so far, we have not been able to find a concrete answer,” he noted.

Lipedema is characterized by the abnormal accumulation of subcutaneous adipose tissue, especially in the lower limbs, and almost exclusively affects cisgender women. The reason for this gender disparity is unclear. It could be an intrinsic characteristic of the disease or a result from clinicians’ lack of familiarity with lipedema, which often leads to misdiagnosis as obesity. This misdiagnosis results in fewer men seeking treatment.

Research has predominantly focused on women, and evidence suggests that hormones play a crucial role in the disease’s pathophysiology. Lipedema typically manifests during periods of hormonal changes, such as puberty, pregnancy, menopause, and hormone replacement therapies, reinforcing the idea that hormones significantly influence the condition’s development and progression.
 

Main Symptoms

Jonathan Kartt, CEO of the Lipedema Foundation, emphasized that intense pain in the areas of adipose tissue accumulation is a hallmark symptom of lipedema, setting it apart from obesity. Pain levels can vary widely among patients, ranging from moderate to severe, with unbearable peaks on certain days. Mr. Kartt stressed the importance of recognizing and addressing this often underestimated symptom.

Lipedema is characterized by a bilateral, symmetrical increase in mass compared with the rest of the body. This is commonly distinguished by the “cuff sign,” a separation between normal tissue in the feet and abnormal tissue from the ankle upward. Other frequent symptoms include a feeling of heaviness, discomfort, fatigue, frequent bruising, and tiredness. A notable sign is the presence of subcutaneous nodules with a texture similar to that of rice grains, which are crucial for differentiating lipedema from other conditions. Palpation during anamnesis is essential to identify these nodules and confirm the diagnosis.

“It is crucial to investigate the family history for genetic predisposition. Additionally, it is fundamental to ask whether, even with weight loss, the affected areas retain accumulated fat. Hormonal changes, pain symptoms, and impact on quality of life should also be carefully evaluated,” advised Mr. Kartt.
 

Diagnostic Tools

André Murad, MD, a clinical consultant at the Instituto Lipedema Brazil, has been exploring new diagnostic approaches for lipedema beyond traditional anamnesis. During his presentation at the ICO, he shared studies on the efficacy of imaging exams such as ultrasound, tomography, and MRI in diagnosing the characteristic lipedema-associated increase in subcutaneous tissue.

He also discussed lymphangiography and lymphoscintigraphy, highlighting the use of magnetic resonance lymphangiography to evaluate dilated lymphatic vessels often observed in patients with lipedema. “By injecting contrast into the feet, this technique allows the evaluation of vessels, which are usually dilated, indicating characteristic lymphatic system overload in lipedema. Lymphoscintigraphy is crucial for detecting associated lymphedema, revealing delayed lymphatic flow and asymmetry between limbs in cases of lipedema without lymphedema,” he explained.

Despite the various diagnostic options, Dr. Murad highlighted two highly effective studies. A Brazilian study used ultrasound to establish a cutoff point of 11.7 mm in the pretibial subcutaneous tissue thickness, achieving 96% specificity for diagnosis. Another study emphasized the value of dual-energy x-ray absorptiometry (DXA), which demonstrated 95% sensitivity. This method assesses fat distribution by correlating the amount present in the legs with the total body, providing a cost-effective and accessible option for specialists.

“DXA allows for a precise mathematical evaluation of fat distribution relative to the total body. A ratio of 0.38 in the leg-to-body relationship is a significant indicator of high suspicion of lipedema,” highlighted Dr. Murad. “In clinical practice, many patients self-diagnose with lipedema, but the clinical exam often reveals no disproportion, with the leg-to-body ratio below 0.38 being common in these cases,” he added.
 

 

 

Treatment Approaches

Treatments for lipedema are still evolving, with considerable debate about the best approach. While some specialists advocate exclusively for conservative treatment, others recommend combining these methods with surgical interventions, depending on the stage of the disease. The relative novelty of lipedema and the scarcity of robust, long-term studies contribute to the uncertainty around treatment efficacy.

Conservative treatment typically includes compression, lymphatic drainage techniques, and pressure therapy. An active lifestyle and a healthy diet are also recommended. Although these measures do not prevent the accumulation of adipose tissue, they help reduce inflammation and improve quality of life. “Even though the causes of lipedema are not fully known, lifestyle management is essential for controlling symptoms, starting with an anti-inflammatory diet,” emphasized Dr. Murad.

Because insulin promotes lipogenesis, a diet that avoids spikes in glycemic and insulin levels is advisable. Insulin resistance can exacerbate edema formation, so a Mediterranean diet may be beneficial. This diet limits fast-absorbing carbohydrates, such as added sugar, refined grains, and ultraprocessed foods, while promoting complex carbohydrates from whole grains and legumes.

Dr. Murad also presented a study evaluating the potential benefits of a low-carbohydrate, high-fat diet for patients with lipedema. The study demonstrated weight loss, reduced body fat, controlled leg volume, and, notably, pain relief.

For more advanced stages of lipedema, plastic surgery is often considered when conservative approaches do not yield satisfactory results. Some specialists advocate for surgery as an effective way to remove diseased adipose cells and reduce excess fat accumulation, which can improve physical appearance and associated pain. There is a growing consensus that surgical intervention should be performed early, ideally in stage I of IV, to maximize efficacy and prevent disease progression.

Fábio Masato Kamamoto, MD, a plastic surgeon and director of the Instituto Lipedema Brazil, shared insights into surgical treatments for lipedema. He discussed techniques from liposuction to advanced skin retraction and dermolipectomy, crucial for addressing more advanced stages of the condition. “It’s a complex process that demands precision to protect the lymphatic system, especially considering the characteristic nodules of lipedema,” he noted.

Dr. Kamamoto discussed a former patient with stage III lipedema. In the initial stage, he performed liposuction, removing 8 L of fat and 3.4 kg of skin. After 6 months, a follow-up procedure resulted in a total removal of 15 kg. Complementary procedures, such as microneedling, were performed to stimulate collagen production and reduce skin sagging. In addition to cosmetic improvements, the procedure also removed the distinctive lipedema nodules, which Mr. Kartt described as feeling like “rice grains.” Removing these nodules significantly alleviates pain, according to Dr. Kamamoto.

The benefits of surgical treatment for lipedema can be long lasting. Dr. Kamamoto noted that fat tends not to reaccumulate in treated areas, with patients often experiencing lower weight, reduced edema, and decreased pain over time. “While we hope that patients do not regain weight, the benefits of surgery persist even if weight is regained. Therefore, combining conservative and surgical treatments remains a valid and effective approach,” he concluded.

Dr. Scherer highlighted that despite various approaches, there is still no definitive “magic signature” that fully explains lipedema. This lack of clarity directly affects the effectiveness of diagnoses and treatments. He expressed hope that future integration of data from different studies and approaches will lead to the identification of a clinically useful molecular signature. “The true cause of lipedema remains unknown, requiring more speculation, hypothesis formulation, and testing for significant discoveries. This situation is frustrating, as the disease affects many women who lack a clear diagnosis that differentiates them from patients with obesity, as well as evidence-based recommendations,” he concluded.
 

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Advantages of a Pediatric Rheumatology/Dermatology Clinic Evaluated

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Among patients who presented to a combined pediatric rheumatology/dermatology clinic (RDC) at the University of California, San Francisco (UCSF), 24% presented without a confirmed diagnosis, and only 41% received a diagnosis during their first clinic visit, results from a retrospective cohort study showed.

“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”

To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.

In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.

Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).



Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.

The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.

“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”

In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.

“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”

The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

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Among patients who presented to a combined pediatric rheumatology/dermatology clinic (RDC) at the University of California, San Francisco (UCSF), 24% presented without a confirmed diagnosis, and only 41% received a diagnosis during their first clinic visit, results from a retrospective cohort study showed.

“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”

To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.

In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.

Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).



Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.

The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.

“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”

In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.

“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”

The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

Among patients who presented to a combined pediatric rheumatology/dermatology clinic (RDC) at the University of California, San Francisco (UCSF), 24% presented without a confirmed diagnosis, and only 41% received a diagnosis during their first clinic visit, results from a retrospective cohort study showed.

“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”

To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.

In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.

Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).



Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.

The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.

“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”

In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.

“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”

The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

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Underserved Families Share Ways to Improve Access to Pediatric Dermatologists

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When Black, Hispanic, and American Indian/Alaska Native parents or guardians were asked about barriers and facilitators to accessing pediatric dermatology care for their children, a theme emerged that surprised lead study author Lucinda L. Kohn, MD, MHS.

“Most families said that racial concordance didn’t matter that much, but they did place high value on being heard,” Dr. Kohn, of the Department of Dermatology at the University of Colorado, Aurora, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “Being heard means that their experience was respected; that their questions and worries were anticipated, addressed, and answered; and that their feelings were acknowledged.”

Dr. Kohn
Dr. Lucinda L. Kohn

As a way to understand these families’ knowledge, attitudes, and beliefs about access to pediatric dermatology care and how the hospital system and medical team could better support them, Dr. Kohn and colleagues conducted in-depth, semi-structured interviews with 32 English-speaking parents and/or guardians of children who received care at the Children’s Hospital Colorado Anschutz Medical Campus pediatric dermatology clinic. The researchers conducted and recorded the 30- to 60-minute interviews via Zoom or phone call from October 17, 2023, to January 23, 2024. Domains of interest included participant background and experiences, communication preferences, and experience accessing pediatric dermatology care. Next, Dr. Kohn and colleagues used a reflexive, team-based inductive approach to carry out a thematic analysis from the interviews.

The mean age of the 32 study participants was 38.9 years; 14 (43.75%) identified as Hispanic, 11 (34.38%) as Black, and 12 (37.50%) as American Indian/Alaska Native (response categories were not mutually exclusive). Several themes emerged from analysis of the interviews. Barriers to receiving pediatric dermatology care included distrust of the healthcare system, generational and community lack of awareness about dermatology, distance to the hospital, and household income.

“One family mentioned that they needed to save up for 3 months to be able to afford the drive, hotel, and food needed for their child to attend their pediatric dermatology visit,” Dr. Kohn said. “As we know, most pediatric dermatology visits are 10-15 minutes long, so that they needed to cut groceries for 3 months to be able to see a pediatric dermatologist for 10-15 minutes is just heart wrenching. Families also didn’t understand the large teams that we have in medicine: The medical students, residents, nurses, medical assistants, attendings, and physician extenders.”



One key facilitator to receiving pediatric dermatology care was the family’s perception that the provider shares their minoritized experience because of similarities in skin tone. “When it’s your own race, whether it’s Black, Hispanic, or you know, we feel like when it’s someone like me, they will look out for me more,” one study participant said. Other facilitators expressed by the study participants included increased representation from the family’s community at all levels of healthcare (“the more you see providers and people in a space that look like you, I think the more welcoming it will feel,” one said) and normalizing dermatology care (“letting it be known that going to the dermatologist is just like going to a regular doctor,” another said).

Dr. Kohn acknowledged certain limitations of the study, including its single-center qualitative design. “Qualitative studies are not generalizable, but they do dive into the lived experiences of a few,” she said. “There aren’t a lot of qualitative studies in derm, so even though this was a very simple study, we hope the findings will help us to support our most diverse and underserved families access the pediatric dermatology care that they need.”

The researchers reported having no relevant financial disclosures. The study was recognized as an award-winning poster at the meeting.

A version of this article appeared on Medscape.com.

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When Black, Hispanic, and American Indian/Alaska Native parents or guardians were asked about barriers and facilitators to accessing pediatric dermatology care for their children, a theme emerged that surprised lead study author Lucinda L. Kohn, MD, MHS.

“Most families said that racial concordance didn’t matter that much, but they did place high value on being heard,” Dr. Kohn, of the Department of Dermatology at the University of Colorado, Aurora, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “Being heard means that their experience was respected; that their questions and worries were anticipated, addressed, and answered; and that their feelings were acknowledged.”

Dr. Kohn
Dr. Lucinda L. Kohn

As a way to understand these families’ knowledge, attitudes, and beliefs about access to pediatric dermatology care and how the hospital system and medical team could better support them, Dr. Kohn and colleagues conducted in-depth, semi-structured interviews with 32 English-speaking parents and/or guardians of children who received care at the Children’s Hospital Colorado Anschutz Medical Campus pediatric dermatology clinic. The researchers conducted and recorded the 30- to 60-minute interviews via Zoom or phone call from October 17, 2023, to January 23, 2024. Domains of interest included participant background and experiences, communication preferences, and experience accessing pediatric dermatology care. Next, Dr. Kohn and colleagues used a reflexive, team-based inductive approach to carry out a thematic analysis from the interviews.

The mean age of the 32 study participants was 38.9 years; 14 (43.75%) identified as Hispanic, 11 (34.38%) as Black, and 12 (37.50%) as American Indian/Alaska Native (response categories were not mutually exclusive). Several themes emerged from analysis of the interviews. Barriers to receiving pediatric dermatology care included distrust of the healthcare system, generational and community lack of awareness about dermatology, distance to the hospital, and household income.

“One family mentioned that they needed to save up for 3 months to be able to afford the drive, hotel, and food needed for their child to attend their pediatric dermatology visit,” Dr. Kohn said. “As we know, most pediatric dermatology visits are 10-15 minutes long, so that they needed to cut groceries for 3 months to be able to see a pediatric dermatologist for 10-15 minutes is just heart wrenching. Families also didn’t understand the large teams that we have in medicine: The medical students, residents, nurses, medical assistants, attendings, and physician extenders.”



One key facilitator to receiving pediatric dermatology care was the family’s perception that the provider shares their minoritized experience because of similarities in skin tone. “When it’s your own race, whether it’s Black, Hispanic, or you know, we feel like when it’s someone like me, they will look out for me more,” one study participant said. Other facilitators expressed by the study participants included increased representation from the family’s community at all levels of healthcare (“the more you see providers and people in a space that look like you, I think the more welcoming it will feel,” one said) and normalizing dermatology care (“letting it be known that going to the dermatologist is just like going to a regular doctor,” another said).

Dr. Kohn acknowledged certain limitations of the study, including its single-center qualitative design. “Qualitative studies are not generalizable, but they do dive into the lived experiences of a few,” she said. “There aren’t a lot of qualitative studies in derm, so even though this was a very simple study, we hope the findings will help us to support our most diverse and underserved families access the pediatric dermatology care that they need.”

The researchers reported having no relevant financial disclosures. The study was recognized as an award-winning poster at the meeting.

A version of this article appeared on Medscape.com.

When Black, Hispanic, and American Indian/Alaska Native parents or guardians were asked about barriers and facilitators to accessing pediatric dermatology care for their children, a theme emerged that surprised lead study author Lucinda L. Kohn, MD, MHS.

“Most families said that racial concordance didn’t matter that much, but they did place high value on being heard,” Dr. Kohn, of the Department of Dermatology at the University of Colorado, Aurora, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “Being heard means that their experience was respected; that their questions and worries were anticipated, addressed, and answered; and that their feelings were acknowledged.”

Dr. Kohn
Dr. Lucinda L. Kohn

As a way to understand these families’ knowledge, attitudes, and beliefs about access to pediatric dermatology care and how the hospital system and medical team could better support them, Dr. Kohn and colleagues conducted in-depth, semi-structured interviews with 32 English-speaking parents and/or guardians of children who received care at the Children’s Hospital Colorado Anschutz Medical Campus pediatric dermatology clinic. The researchers conducted and recorded the 30- to 60-minute interviews via Zoom or phone call from October 17, 2023, to January 23, 2024. Domains of interest included participant background and experiences, communication preferences, and experience accessing pediatric dermatology care. Next, Dr. Kohn and colleagues used a reflexive, team-based inductive approach to carry out a thematic analysis from the interviews.

The mean age of the 32 study participants was 38.9 years; 14 (43.75%) identified as Hispanic, 11 (34.38%) as Black, and 12 (37.50%) as American Indian/Alaska Native (response categories were not mutually exclusive). Several themes emerged from analysis of the interviews. Barriers to receiving pediatric dermatology care included distrust of the healthcare system, generational and community lack of awareness about dermatology, distance to the hospital, and household income.

“One family mentioned that they needed to save up for 3 months to be able to afford the drive, hotel, and food needed for their child to attend their pediatric dermatology visit,” Dr. Kohn said. “As we know, most pediatric dermatology visits are 10-15 minutes long, so that they needed to cut groceries for 3 months to be able to see a pediatric dermatologist for 10-15 minutes is just heart wrenching. Families also didn’t understand the large teams that we have in medicine: The medical students, residents, nurses, medical assistants, attendings, and physician extenders.”



One key facilitator to receiving pediatric dermatology care was the family’s perception that the provider shares their minoritized experience because of similarities in skin tone. “When it’s your own race, whether it’s Black, Hispanic, or you know, we feel like when it’s someone like me, they will look out for me more,” one study participant said. Other facilitators expressed by the study participants included increased representation from the family’s community at all levels of healthcare (“the more you see providers and people in a space that look like you, I think the more welcoming it will feel,” one said) and normalizing dermatology care (“letting it be known that going to the dermatologist is just like going to a regular doctor,” another said).

Dr. Kohn acknowledged certain limitations of the study, including its single-center qualitative design. “Qualitative studies are not generalizable, but they do dive into the lived experiences of a few,” she said. “There aren’t a lot of qualitative studies in derm, so even though this was a very simple study, we hope the findings will help us to support our most diverse and underserved families access the pediatric dermatology care that they need.”

The researchers reported having no relevant financial disclosures. The study was recognized as an award-winning poster at the meeting.

A version of this article appeared on Medscape.com.

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Study Finds Gout Drug Effective for Aphthous Ulcers in Children

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Colchicine is an effective treatment for most pediatric patients with complex aphthous stomatitis (CAS), results from a small retrospective study showed.

“Complex aphthous stomatitis in children is typically treated with topical supportive care, which is often not effective,” one of the study investigators, Ananya Shah, a third-year medical student at the University of Rochester School of Medicine & Dentistry, Rochester, New York, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “There is limited research on CAS and its treatment in children. Colchicine is often used for treatment of CAS in adults, but its use in children has not been studied.”

Ms. Shah, in collaboration with Hilary Kunkel, MD, Nessa Aghazadeh, MD, and Megha Tollefson, MD, of the Department of Dermatology, Mayo Clinic, Rochester, Minnesota, retrospectively reviewed the charts of 20 children diagnosed with CAS who were treated with colchicine, an anti-inflammatory drug often used to treat gout, at the clinic between 2000 and 2023. Treatment responses were defined as no response, partial response, and complete response. Half of the patients were girls, and their median age at presentation was 5 years.

Ulcers were most commonly located in the buccal mucosa (80%), followed by the gingiva (50%), the mucosal lip (50%), and the palate (40%). Nearly all patients (95%) reported that the CAS caused difficulties with eating or drinking. Other effects on their quality of life included weight loss (35%), bleeding (30%), and difficulty brushing teeth (25%). “I was surprised by how much CAS impacts pediatric patients’ quality of life,” Ms. Shah said. “Almost all of the patients experienced trouble with basic activities of daily living, including eating and drinking. In addition, CAS negatively impacted mental health and led to missed school for patients.”



The researchers had follow-up data on responses to colchicine for 14 of the 20 patients. Of these, 12 (86%) had symptom improvement, 5 (36%) had a complete response, 8 (57%) had a partial response, and 1 (7%) did not respond. Nine patients (64%) experienced side effects. Of these, six had diarrhea, two had nausea, and one had constipation.

“Colchicine should be considered as a treatment in pediatric patients who have refractory complex aphthous stomatitis as it is generally well tolerated with minimal side effects,” Ms. Shah said. She acknowledged certain limitations of the study, including its single-center, retrospective design.

The researchers reported having no relevant disclosures.

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

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Colchicine is an effective treatment for most pediatric patients with complex aphthous stomatitis (CAS), results from a small retrospective study showed.

“Complex aphthous stomatitis in children is typically treated with topical supportive care, which is often not effective,” one of the study investigators, Ananya Shah, a third-year medical student at the University of Rochester School of Medicine & Dentistry, Rochester, New York, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “There is limited research on CAS and its treatment in children. Colchicine is often used for treatment of CAS in adults, but its use in children has not been studied.”

Ms. Shah, in collaboration with Hilary Kunkel, MD, Nessa Aghazadeh, MD, and Megha Tollefson, MD, of the Department of Dermatology, Mayo Clinic, Rochester, Minnesota, retrospectively reviewed the charts of 20 children diagnosed with CAS who were treated with colchicine, an anti-inflammatory drug often used to treat gout, at the clinic between 2000 and 2023. Treatment responses were defined as no response, partial response, and complete response. Half of the patients were girls, and their median age at presentation was 5 years.

Ulcers were most commonly located in the buccal mucosa (80%), followed by the gingiva (50%), the mucosal lip (50%), and the palate (40%). Nearly all patients (95%) reported that the CAS caused difficulties with eating or drinking. Other effects on their quality of life included weight loss (35%), bleeding (30%), and difficulty brushing teeth (25%). “I was surprised by how much CAS impacts pediatric patients’ quality of life,” Ms. Shah said. “Almost all of the patients experienced trouble with basic activities of daily living, including eating and drinking. In addition, CAS negatively impacted mental health and led to missed school for patients.”



The researchers had follow-up data on responses to colchicine for 14 of the 20 patients. Of these, 12 (86%) had symptom improvement, 5 (36%) had a complete response, 8 (57%) had a partial response, and 1 (7%) did not respond. Nine patients (64%) experienced side effects. Of these, six had diarrhea, two had nausea, and one had constipation.

“Colchicine should be considered as a treatment in pediatric patients who have refractory complex aphthous stomatitis as it is generally well tolerated with minimal side effects,” Ms. Shah said. She acknowledged certain limitations of the study, including its single-center, retrospective design.

The researchers reported having no relevant disclosures.

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

Colchicine is an effective treatment for most pediatric patients with complex aphthous stomatitis (CAS), results from a small retrospective study showed.

“Complex aphthous stomatitis in children is typically treated with topical supportive care, which is often not effective,” one of the study investigators, Ananya Shah, a third-year medical student at the University of Rochester School of Medicine & Dentistry, Rochester, New York, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “There is limited research on CAS and its treatment in children. Colchicine is often used for treatment of CAS in adults, but its use in children has not been studied.”

Ms. Shah, in collaboration with Hilary Kunkel, MD, Nessa Aghazadeh, MD, and Megha Tollefson, MD, of the Department of Dermatology, Mayo Clinic, Rochester, Minnesota, retrospectively reviewed the charts of 20 children diagnosed with CAS who were treated with colchicine, an anti-inflammatory drug often used to treat gout, at the clinic between 2000 and 2023. Treatment responses were defined as no response, partial response, and complete response. Half of the patients were girls, and their median age at presentation was 5 years.

Ulcers were most commonly located in the buccal mucosa (80%), followed by the gingiva (50%), the mucosal lip (50%), and the palate (40%). Nearly all patients (95%) reported that the CAS caused difficulties with eating or drinking. Other effects on their quality of life included weight loss (35%), bleeding (30%), and difficulty brushing teeth (25%). “I was surprised by how much CAS impacts pediatric patients’ quality of life,” Ms. Shah said. “Almost all of the patients experienced trouble with basic activities of daily living, including eating and drinking. In addition, CAS negatively impacted mental health and led to missed school for patients.”



The researchers had follow-up data on responses to colchicine for 14 of the 20 patients. Of these, 12 (86%) had symptom improvement, 5 (36%) had a complete response, 8 (57%) had a partial response, and 1 (7%) did not respond. Nine patients (64%) experienced side effects. Of these, six had diarrhea, two had nausea, and one had constipation.

“Colchicine should be considered as a treatment in pediatric patients who have refractory complex aphthous stomatitis as it is generally well tolerated with minimal side effects,” Ms. Shah said. She acknowledged certain limitations of the study, including its single-center, retrospective design.

The researchers reported having no relevant disclosures.

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

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Safety Standards a Top Priority for ASLMS President

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Tue, 07/30/2024 - 15:49

Arisa E. Ortiz, MD, began her term as president of the American Society for Laser Medicine and Surgery (ASLMS) during the organization’s annual meeting in April 2024.

After earning her medical degree from Albany Medical College, Albany, New York, Dr. Ortiz, a native of Los Angeles, completed her dermatology residency training at the University of California, Irvine, and the university’s Beckman Laser Institute. Next, she completed a laser and cosmetic dermatology fellowship at Massachusetts General Hospital, Harvard Medical School, and the Wellman Center for Photomedicine, all in Boston, and acquired additional fellowship training in Mohs micrographic surgery at the University of California, San Diego (UCSD). Dr. Ortiz is currently director of laser and cosmetic dermatology and a clinical professor of dermatology at UCSD.

Dr. Arisa E. Ortiz
Dr. Arisa E. Ortiz

She has authored more than 60 publications on new innovations in cutaneous surgery and is a frequent speaker at meetings of the American Academy of Dermatology, the American Society for Dermatologic Surgery (ASDS), and ASLMS, and she cochairs the annual Masters of Aesthetics Symposium in San Diego. Dr. Ortiz has received several awards, including the 2024 Castle Connolly Top Doctor Award and the Exceptional Women in Medicine Award; Newsweek America’s Best Dermatologists; the ASLMS Dr. Horace Furumoto Young Investigator Award, the ASLMS Best of Session Award for Cutaneous Applications, and the ASDS President’s Outstanding Service Award. Her primary research focuses on the laser treatment of nonmelanoma skin cancer.

In an interview, Dr. Ortiz spoke about her goals as ASLMS president and other topics related to dermatology.

Who inspired you most to become a doctor?

I’ve wanted to become a doctor for as long as I can remember. My fascination with science and the idea of helping people improve their health were driving forces. However, my biggest influence early on was my uncle, who was a pediatrician. His dedication and passion for medicine deeply inspired me and solidified my desire to pursue a career in healthcare.


I understand that a bout with chickenpox as a teenager influenced your decision to specialize in dermatology.

It’s an interesting and somewhat humorous story. When I was 18, I contracted chickenpox and ended up with scars on my face. It was a tough experience as a teenager, but it’s fascinating how such events can shape your life. In my quest for help, I opened the Yellow Pages and randomly chose a dermatologist nearby, who turned out to be Gary Lask, MD, director of lasers at UCLA [University of California, Los Angeles]. During our visit, I mentioned that I was premed, and he encouraged me to consider dermatology. About 6 years later, as a second-year medical student, I realized my passion for dermatology. I reached out to Dr. Lask and told him: “You were right. I want to be a dermatologist. Now, you have to help me get in!” Today, he remains my mentor, and I am deeply grateful for his guidance and support on this journey.



One of the initiatives for your term as ASLMS president includes a focus on safety standards for lasers and energy-based devices. Why is this important now?

courtesy Dr. Arisa E. Ortiz
Dr. Arisa E. Ortiz, director of laser and cosmetic dermatology and a clinical professor of dermatology at the University of California, San Diego

Working at the university, I frequently encounter severe complications arising from the improper use of lasers and energy-based devices. As these procedures gain popularity, more providers are offering them, yet often without adequate training. As the world’s premier laser society, it is our duty to ensure patient safety. In the ever-evolving field of laser medicine, it is crucial that we continually strive to enhance the regulation of laser usage, ensuring that patients receive the highest standard of care with minimal risk.



One of the suggestions you have for the safety initiative is to offer a rigorous laser safety certification course with continuing education opportunities as a way foster a culture of heightened safety standards. Please explain what would be included in such a course and how it would align with current efforts to report adverse events such as the ASDS-Northwestern University Cutaneous Procedures Adverse Events Reporting (CAPER) registry and the Food and Drug Administration’s MedWatch Program.

A laser safety certification task force has been established to determine the best approach for developing a comprehensive course. The task force aims to assess the necessity of a formal safety certification in our industry, identify the resources needed to support such a certification, establish general safety protocols to form the content foundation, address potential legal concerns, and outline the process for formal certification program recognition. This exploratory work is expected to conclude by the end of the year. The proposed course may include modules on the fundamentals of laser physics, safe operation techniques, patient selection and management, and emergency protocols. Continuing education opportunities would be considered to keep practitioners updated on the latest advancements and safety protocols in laser medicine, thereby fostering a culture of heightened safety standards.



Another initiative for your term is the rollout of a tattoo removal program for former gang members based on the UCSD Clean Slate Tattoo Removal Program. Please tell us more about your vision for this national program.

UCSD Dermatology, in collaboration with UCSD Global Health, has been involved in the Clean Slate Tattoo Removal Program for the past decade. This initiative supports and rehabilitates former gang members by offering laser tattoo removal, helping them reintegrate into society. My vision is to equip our members with the necessary protocols to implement this outreach initiative in their own communities. By providing opportunities for reform and growth, we aim to foster safer and more inclusive communities nationwide.



You were one of the first clinicians to use a laser to treat basal cell carcinoma (BCC). Who are the ideal candidates for this procedure? Is the technique ready for wide clinical adoption? If not, what kind of studies are needed to make it so?

My research passion lies in optimizing laser treatments for BCC. During my fellowship with R. Rox Anderson, MD, and Mathew Avram, MD, at the MGH Wellman Center for Photomedicine, we conducted a pilot study using the 1064-nm Nd:YAG laser, achieving a 92% clearance rate after one treatment. Inspired by these results, we conducted a larger multicenter study, which demonstrated a 90% clearance rate after a single treatment. I now incorporate this technique into my daily practice. The ideal candidates for this procedure are patients with BCC that do not meet the Mohs Appropriate Use Criteria, such as those with nodular or superficial BCC subtypes on the body, individuals who are poor surgical candidates, or those who are surgically exhausted. However, I do not recommend this treatment for patients who are primarily concerned about facial scarring, particularly younger individuals; in such cases, Mohs surgery still remains the preferred option. While I believe this technique is ready for broader clinical adoption, it requires an understanding of laser endpoints. We are also exploring antibody-targeted gold nanorods to enhance the selectivity and standardization of the treatment.



Who inspires you most in your work today?

My patients are my greatest inspiration. Their trust and dedication motivate me to stay at the forefront of dermatologic advancements, ensuring I provide the most cutting-edge and safe treatments possible. Their commitment drives my relentless pursuit of continuous learning and innovation in the field.





What’s the best advice you can give to female dermatologists seeking leadership positions at the local, state, or national level?

My best advice is to have the courage to ask for what you seek. Societies are always looking for members who are eager to participate and contribute. If you express your interest in becoming more involved, there is likely a position available for you. The more you are willing to contribute to a society, the more likely you will be noticed and excel into higher leadership positions. Take initiative, show your commitment, and don’t hesitate to step forward when opportunities arise.



What’s the one tried-and-true laser- or energy-based procedure that you consider a “must” for your dermatology practice? And why?

Determining a single “must-have” laser- or energy-based procedure is a challenging question as it greatly depends on the specific needs of your patient population. However, one of the most common concerns among patients involves issues like redness and pigmentation. Therefore, having a versatile laser or an intense pulsed light device that effectively targets both red and brown pigmentation is indispensable for most practices.



In your view, what are the top three trends in aesthetic dermatology?

Over the years, I have observed several key trends in aesthetic dermatology:

  • Minimally invasive procedures. There is a growing preference for less invasive treatments. Patients increasingly desire minimal downtime while still achieving significant results.
  • Advancements in laser and energy-based devices for darker skin. There have been substantial advancements in technologies that are safer and more effective for darker skin tones. These developments play a crucial role in addressing diverse patient needs and providing inclusive dermatologic care.
  • Natural aesthetic. I am hopeful that the trend toward an overdone appearance is fading. There seems to be a shift back towards a more natural and conservative aesthetic, emphasizing subtle enhancements over dramatic changes.



What development in dermatology are you most excited about in the next 5 years?

I am most excited to see how artificial intelligence and robotics play a role in energy-based devices.

Dr. Ortiz disclosed having financial relationships with several pharmaceutical and device companies. She is also cochair of the MOAS.

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Arisa E. Ortiz, MD, began her term as president of the American Society for Laser Medicine and Surgery (ASLMS) during the organization’s annual meeting in April 2024.

After earning her medical degree from Albany Medical College, Albany, New York, Dr. Ortiz, a native of Los Angeles, completed her dermatology residency training at the University of California, Irvine, and the university’s Beckman Laser Institute. Next, she completed a laser and cosmetic dermatology fellowship at Massachusetts General Hospital, Harvard Medical School, and the Wellman Center for Photomedicine, all in Boston, and acquired additional fellowship training in Mohs micrographic surgery at the University of California, San Diego (UCSD). Dr. Ortiz is currently director of laser and cosmetic dermatology and a clinical professor of dermatology at UCSD.

Dr. Arisa E. Ortiz
Dr. Arisa E. Ortiz

She has authored more than 60 publications on new innovations in cutaneous surgery and is a frequent speaker at meetings of the American Academy of Dermatology, the American Society for Dermatologic Surgery (ASDS), and ASLMS, and she cochairs the annual Masters of Aesthetics Symposium in San Diego. Dr. Ortiz has received several awards, including the 2024 Castle Connolly Top Doctor Award and the Exceptional Women in Medicine Award; Newsweek America’s Best Dermatologists; the ASLMS Dr. Horace Furumoto Young Investigator Award, the ASLMS Best of Session Award for Cutaneous Applications, and the ASDS President’s Outstanding Service Award. Her primary research focuses on the laser treatment of nonmelanoma skin cancer.

In an interview, Dr. Ortiz spoke about her goals as ASLMS president and other topics related to dermatology.

Who inspired you most to become a doctor?

I’ve wanted to become a doctor for as long as I can remember. My fascination with science and the idea of helping people improve their health were driving forces. However, my biggest influence early on was my uncle, who was a pediatrician. His dedication and passion for medicine deeply inspired me and solidified my desire to pursue a career in healthcare.


I understand that a bout with chickenpox as a teenager influenced your decision to specialize in dermatology.

It’s an interesting and somewhat humorous story. When I was 18, I contracted chickenpox and ended up with scars on my face. It was a tough experience as a teenager, but it’s fascinating how such events can shape your life. In my quest for help, I opened the Yellow Pages and randomly chose a dermatologist nearby, who turned out to be Gary Lask, MD, director of lasers at UCLA [University of California, Los Angeles]. During our visit, I mentioned that I was premed, and he encouraged me to consider dermatology. About 6 years later, as a second-year medical student, I realized my passion for dermatology. I reached out to Dr. Lask and told him: “You were right. I want to be a dermatologist. Now, you have to help me get in!” Today, he remains my mentor, and I am deeply grateful for his guidance and support on this journey.



One of the initiatives for your term as ASLMS president includes a focus on safety standards for lasers and energy-based devices. Why is this important now?

courtesy Dr. Arisa E. Ortiz
Dr. Arisa E. Ortiz, director of laser and cosmetic dermatology and a clinical professor of dermatology at the University of California, San Diego

Working at the university, I frequently encounter severe complications arising from the improper use of lasers and energy-based devices. As these procedures gain popularity, more providers are offering them, yet often without adequate training. As the world’s premier laser society, it is our duty to ensure patient safety. In the ever-evolving field of laser medicine, it is crucial that we continually strive to enhance the regulation of laser usage, ensuring that patients receive the highest standard of care with minimal risk.



One of the suggestions you have for the safety initiative is to offer a rigorous laser safety certification course with continuing education opportunities as a way foster a culture of heightened safety standards. Please explain what would be included in such a course and how it would align with current efforts to report adverse events such as the ASDS-Northwestern University Cutaneous Procedures Adverse Events Reporting (CAPER) registry and the Food and Drug Administration’s MedWatch Program.

A laser safety certification task force has been established to determine the best approach for developing a comprehensive course. The task force aims to assess the necessity of a formal safety certification in our industry, identify the resources needed to support such a certification, establish general safety protocols to form the content foundation, address potential legal concerns, and outline the process for formal certification program recognition. This exploratory work is expected to conclude by the end of the year. The proposed course may include modules on the fundamentals of laser physics, safe operation techniques, patient selection and management, and emergency protocols. Continuing education opportunities would be considered to keep practitioners updated on the latest advancements and safety protocols in laser medicine, thereby fostering a culture of heightened safety standards.



Another initiative for your term is the rollout of a tattoo removal program for former gang members based on the UCSD Clean Slate Tattoo Removal Program. Please tell us more about your vision for this national program.

UCSD Dermatology, in collaboration with UCSD Global Health, has been involved in the Clean Slate Tattoo Removal Program for the past decade. This initiative supports and rehabilitates former gang members by offering laser tattoo removal, helping them reintegrate into society. My vision is to equip our members with the necessary protocols to implement this outreach initiative in their own communities. By providing opportunities for reform and growth, we aim to foster safer and more inclusive communities nationwide.



You were one of the first clinicians to use a laser to treat basal cell carcinoma (BCC). Who are the ideal candidates for this procedure? Is the technique ready for wide clinical adoption? If not, what kind of studies are needed to make it so?

My research passion lies in optimizing laser treatments for BCC. During my fellowship with R. Rox Anderson, MD, and Mathew Avram, MD, at the MGH Wellman Center for Photomedicine, we conducted a pilot study using the 1064-nm Nd:YAG laser, achieving a 92% clearance rate after one treatment. Inspired by these results, we conducted a larger multicenter study, which demonstrated a 90% clearance rate after a single treatment. I now incorporate this technique into my daily practice. The ideal candidates for this procedure are patients with BCC that do not meet the Mohs Appropriate Use Criteria, such as those with nodular or superficial BCC subtypes on the body, individuals who are poor surgical candidates, or those who are surgically exhausted. However, I do not recommend this treatment for patients who are primarily concerned about facial scarring, particularly younger individuals; in such cases, Mohs surgery still remains the preferred option. While I believe this technique is ready for broader clinical adoption, it requires an understanding of laser endpoints. We are also exploring antibody-targeted gold nanorods to enhance the selectivity and standardization of the treatment.



Who inspires you most in your work today?

My patients are my greatest inspiration. Their trust and dedication motivate me to stay at the forefront of dermatologic advancements, ensuring I provide the most cutting-edge and safe treatments possible. Their commitment drives my relentless pursuit of continuous learning and innovation in the field.





What’s the best advice you can give to female dermatologists seeking leadership positions at the local, state, or national level?

My best advice is to have the courage to ask for what you seek. Societies are always looking for members who are eager to participate and contribute. If you express your interest in becoming more involved, there is likely a position available for you. The more you are willing to contribute to a society, the more likely you will be noticed and excel into higher leadership positions. Take initiative, show your commitment, and don’t hesitate to step forward when opportunities arise.



What’s the one tried-and-true laser- or energy-based procedure that you consider a “must” for your dermatology practice? And why?

Determining a single “must-have” laser- or energy-based procedure is a challenging question as it greatly depends on the specific needs of your patient population. However, one of the most common concerns among patients involves issues like redness and pigmentation. Therefore, having a versatile laser or an intense pulsed light device that effectively targets both red and brown pigmentation is indispensable for most practices.



In your view, what are the top three trends in aesthetic dermatology?

Over the years, I have observed several key trends in aesthetic dermatology:

  • Minimally invasive procedures. There is a growing preference for less invasive treatments. Patients increasingly desire minimal downtime while still achieving significant results.
  • Advancements in laser and energy-based devices for darker skin. There have been substantial advancements in technologies that are safer and more effective for darker skin tones. These developments play a crucial role in addressing diverse patient needs and providing inclusive dermatologic care.
  • Natural aesthetic. I am hopeful that the trend toward an overdone appearance is fading. There seems to be a shift back towards a more natural and conservative aesthetic, emphasizing subtle enhancements over dramatic changes.



What development in dermatology are you most excited about in the next 5 years?

I am most excited to see how artificial intelligence and robotics play a role in energy-based devices.

Dr. Ortiz disclosed having financial relationships with several pharmaceutical and device companies. She is also cochair of the MOAS.

Arisa E. Ortiz, MD, began her term as president of the American Society for Laser Medicine and Surgery (ASLMS) during the organization’s annual meeting in April 2024.

After earning her medical degree from Albany Medical College, Albany, New York, Dr. Ortiz, a native of Los Angeles, completed her dermatology residency training at the University of California, Irvine, and the university’s Beckman Laser Institute. Next, she completed a laser and cosmetic dermatology fellowship at Massachusetts General Hospital, Harvard Medical School, and the Wellman Center for Photomedicine, all in Boston, and acquired additional fellowship training in Mohs micrographic surgery at the University of California, San Diego (UCSD). Dr. Ortiz is currently director of laser and cosmetic dermatology and a clinical professor of dermatology at UCSD.

Dr. Arisa E. Ortiz
Dr. Arisa E. Ortiz

She has authored more than 60 publications on new innovations in cutaneous surgery and is a frequent speaker at meetings of the American Academy of Dermatology, the American Society for Dermatologic Surgery (ASDS), and ASLMS, and she cochairs the annual Masters of Aesthetics Symposium in San Diego. Dr. Ortiz has received several awards, including the 2024 Castle Connolly Top Doctor Award and the Exceptional Women in Medicine Award; Newsweek America’s Best Dermatologists; the ASLMS Dr. Horace Furumoto Young Investigator Award, the ASLMS Best of Session Award for Cutaneous Applications, and the ASDS President’s Outstanding Service Award. Her primary research focuses on the laser treatment of nonmelanoma skin cancer.

In an interview, Dr. Ortiz spoke about her goals as ASLMS president and other topics related to dermatology.

Who inspired you most to become a doctor?

I’ve wanted to become a doctor for as long as I can remember. My fascination with science and the idea of helping people improve their health were driving forces. However, my biggest influence early on was my uncle, who was a pediatrician. His dedication and passion for medicine deeply inspired me and solidified my desire to pursue a career in healthcare.


I understand that a bout with chickenpox as a teenager influenced your decision to specialize in dermatology.

It’s an interesting and somewhat humorous story. When I was 18, I contracted chickenpox and ended up with scars on my face. It was a tough experience as a teenager, but it’s fascinating how such events can shape your life. In my quest for help, I opened the Yellow Pages and randomly chose a dermatologist nearby, who turned out to be Gary Lask, MD, director of lasers at UCLA [University of California, Los Angeles]. During our visit, I mentioned that I was premed, and he encouraged me to consider dermatology. About 6 years later, as a second-year medical student, I realized my passion for dermatology. I reached out to Dr. Lask and told him: “You were right. I want to be a dermatologist. Now, you have to help me get in!” Today, he remains my mentor, and I am deeply grateful for his guidance and support on this journey.



One of the initiatives for your term as ASLMS president includes a focus on safety standards for lasers and energy-based devices. Why is this important now?

courtesy Dr. Arisa E. Ortiz
Dr. Arisa E. Ortiz, director of laser and cosmetic dermatology and a clinical professor of dermatology at the University of California, San Diego

Working at the university, I frequently encounter severe complications arising from the improper use of lasers and energy-based devices. As these procedures gain popularity, more providers are offering them, yet often without adequate training. As the world’s premier laser society, it is our duty to ensure patient safety. In the ever-evolving field of laser medicine, it is crucial that we continually strive to enhance the regulation of laser usage, ensuring that patients receive the highest standard of care with minimal risk.



One of the suggestions you have for the safety initiative is to offer a rigorous laser safety certification course with continuing education opportunities as a way foster a culture of heightened safety standards. Please explain what would be included in such a course and how it would align with current efforts to report adverse events such as the ASDS-Northwestern University Cutaneous Procedures Adverse Events Reporting (CAPER) registry and the Food and Drug Administration’s MedWatch Program.

A laser safety certification task force has been established to determine the best approach for developing a comprehensive course. The task force aims to assess the necessity of a formal safety certification in our industry, identify the resources needed to support such a certification, establish general safety protocols to form the content foundation, address potential legal concerns, and outline the process for formal certification program recognition. This exploratory work is expected to conclude by the end of the year. The proposed course may include modules on the fundamentals of laser physics, safe operation techniques, patient selection and management, and emergency protocols. Continuing education opportunities would be considered to keep practitioners updated on the latest advancements and safety protocols in laser medicine, thereby fostering a culture of heightened safety standards.



Another initiative for your term is the rollout of a tattoo removal program for former gang members based on the UCSD Clean Slate Tattoo Removal Program. Please tell us more about your vision for this national program.

UCSD Dermatology, in collaboration with UCSD Global Health, has been involved in the Clean Slate Tattoo Removal Program for the past decade. This initiative supports and rehabilitates former gang members by offering laser tattoo removal, helping them reintegrate into society. My vision is to equip our members with the necessary protocols to implement this outreach initiative in their own communities. By providing opportunities for reform and growth, we aim to foster safer and more inclusive communities nationwide.



You were one of the first clinicians to use a laser to treat basal cell carcinoma (BCC). Who are the ideal candidates for this procedure? Is the technique ready for wide clinical adoption? If not, what kind of studies are needed to make it so?

My research passion lies in optimizing laser treatments for BCC. During my fellowship with R. Rox Anderson, MD, and Mathew Avram, MD, at the MGH Wellman Center for Photomedicine, we conducted a pilot study using the 1064-nm Nd:YAG laser, achieving a 92% clearance rate after one treatment. Inspired by these results, we conducted a larger multicenter study, which demonstrated a 90% clearance rate after a single treatment. I now incorporate this technique into my daily practice. The ideal candidates for this procedure are patients with BCC that do not meet the Mohs Appropriate Use Criteria, such as those with nodular or superficial BCC subtypes on the body, individuals who are poor surgical candidates, or those who are surgically exhausted. However, I do not recommend this treatment for patients who are primarily concerned about facial scarring, particularly younger individuals; in such cases, Mohs surgery still remains the preferred option. While I believe this technique is ready for broader clinical adoption, it requires an understanding of laser endpoints. We are also exploring antibody-targeted gold nanorods to enhance the selectivity and standardization of the treatment.



Who inspires you most in your work today?

My patients are my greatest inspiration. Their trust and dedication motivate me to stay at the forefront of dermatologic advancements, ensuring I provide the most cutting-edge and safe treatments possible. Their commitment drives my relentless pursuit of continuous learning and innovation in the field.





What’s the best advice you can give to female dermatologists seeking leadership positions at the local, state, or national level?

My best advice is to have the courage to ask for what you seek. Societies are always looking for members who are eager to participate and contribute. If you express your interest in becoming more involved, there is likely a position available for you. The more you are willing to contribute to a society, the more likely you will be noticed and excel into higher leadership positions. Take initiative, show your commitment, and don’t hesitate to step forward when opportunities arise.



What’s the one tried-and-true laser- or energy-based procedure that you consider a “must” for your dermatology practice? And why?

Determining a single “must-have” laser- or energy-based procedure is a challenging question as it greatly depends on the specific needs of your patient population. However, one of the most common concerns among patients involves issues like redness and pigmentation. Therefore, having a versatile laser or an intense pulsed light device that effectively targets both red and brown pigmentation is indispensable for most practices.



In your view, what are the top three trends in aesthetic dermatology?

Over the years, I have observed several key trends in aesthetic dermatology:

  • Minimally invasive procedures. There is a growing preference for less invasive treatments. Patients increasingly desire minimal downtime while still achieving significant results.
  • Advancements in laser and energy-based devices for darker skin. There have been substantial advancements in technologies that are safer and more effective for darker skin tones. These developments play a crucial role in addressing diverse patient needs and providing inclusive dermatologic care.
  • Natural aesthetic. I am hopeful that the trend toward an overdone appearance is fading. There seems to be a shift back towards a more natural and conservative aesthetic, emphasizing subtle enhancements over dramatic changes.



What development in dermatology are you most excited about in the next 5 years?

I am most excited to see how artificial intelligence and robotics play a role in energy-based devices.

Dr. Ortiz disclosed having financial relationships with several pharmaceutical and device companies. She is also cochair of the MOAS.

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FDA Approves Deuruxolitinib for Severe Alopecia Areata in Adults

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Mon, 07/29/2024 - 15:10

The Food and Drug Administration (FDA) has approved the oral Janus kinase (JAK) inhibitor deuruxolitinib for the treatment of adults with severe alopecia areata.

The development, which was announced in a July 25, 2024, news release from the drug’s manufacturer Sun Pharma, is based on data from two pivotal randomized, double-blind, placebo-controlled phase 3 clinical trials: THRIVE-AA1 and THRIVE-AA2, which included 1220 adults with severe alopecia areata enrolled at sites in the United States, Canada, and Europe. Study participants had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than 6 months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials.

Deuruxolitinib, which comes in 8-mg tablets, is an oral selective inhibitor of JAK1 and JAK2 and is administered twice a day. According to the company press release, the average patient enrolled in the clinical trials had only 13% of their scalp hair coverage at baseline. At week 24, more than 30% of patients taking deuruxolitinib experiencing 80% or more scalp hair coverage (SALT score ≤ 20). Also, up to 25% of patients had almost all of their scalp hair back at 24 weeks (≥ 90% coverage).



In terms of safety, the data showed that 3.1% of patients who received deuruxolitinib 8 mg twice daily in the phase 2 dose-ranging study and phase 3 randomized placebo-controlled trials discontinued treatment owing to adverse reactions. The three most common adverse events in placebo-controlled trials were headache (12.4% vs 9.4% with placebo), acne (10% vs 4.3% with placebo), and nasopharyngitis (8.1% vs 6.7% with placebo). More than 100 people continued taking deuruxolitinib for more than 3 years.

Deuruxolitinib is the third treatment and third JAK inhibitor approved by the FDA for severe alopecia areata. Baricitinib (Olumiant) was approved in June 2022 for adults with alopecia areata, followed by ritlecitinib (Litfulo) approved in June 2023 for patients aged 12 years and older. 

In a statement from the National Alopecia Areata Foundation (NAAF), Nicole Friedland, NAAF’s president and CEO, said that “it is with tremendous excitement that we welcome the FDA’s approval of a third treatment for severe alopecia areata in as many years.”

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

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The Food and Drug Administration (FDA) has approved the oral Janus kinase (JAK) inhibitor deuruxolitinib for the treatment of adults with severe alopecia areata.

The development, which was announced in a July 25, 2024, news release from the drug’s manufacturer Sun Pharma, is based on data from two pivotal randomized, double-blind, placebo-controlled phase 3 clinical trials: THRIVE-AA1 and THRIVE-AA2, which included 1220 adults with severe alopecia areata enrolled at sites in the United States, Canada, and Europe. Study participants had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than 6 months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials.

Deuruxolitinib, which comes in 8-mg tablets, is an oral selective inhibitor of JAK1 and JAK2 and is administered twice a day. According to the company press release, the average patient enrolled in the clinical trials had only 13% of their scalp hair coverage at baseline. At week 24, more than 30% of patients taking deuruxolitinib experiencing 80% or more scalp hair coverage (SALT score ≤ 20). Also, up to 25% of patients had almost all of their scalp hair back at 24 weeks (≥ 90% coverage).



In terms of safety, the data showed that 3.1% of patients who received deuruxolitinib 8 mg twice daily in the phase 2 dose-ranging study and phase 3 randomized placebo-controlled trials discontinued treatment owing to adverse reactions. The three most common adverse events in placebo-controlled trials were headache (12.4% vs 9.4% with placebo), acne (10% vs 4.3% with placebo), and nasopharyngitis (8.1% vs 6.7% with placebo). More than 100 people continued taking deuruxolitinib for more than 3 years.

Deuruxolitinib is the third treatment and third JAK inhibitor approved by the FDA for severe alopecia areata. Baricitinib (Olumiant) was approved in June 2022 for adults with alopecia areata, followed by ritlecitinib (Litfulo) approved in June 2023 for patients aged 12 years and older. 

In a statement from the National Alopecia Areata Foundation (NAAF), Nicole Friedland, NAAF’s president and CEO, said that “it is with tremendous excitement that we welcome the FDA’s approval of a third treatment for severe alopecia areata in as many years.”

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

The Food and Drug Administration (FDA) has approved the oral Janus kinase (JAK) inhibitor deuruxolitinib for the treatment of adults with severe alopecia areata.

The development, which was announced in a July 25, 2024, news release from the drug’s manufacturer Sun Pharma, is based on data from two pivotal randomized, double-blind, placebo-controlled phase 3 clinical trials: THRIVE-AA1 and THRIVE-AA2, which included 1220 adults with severe alopecia areata enrolled at sites in the United States, Canada, and Europe. Study participants had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than 6 months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials.

Deuruxolitinib, which comes in 8-mg tablets, is an oral selective inhibitor of JAK1 and JAK2 and is administered twice a day. According to the company press release, the average patient enrolled in the clinical trials had only 13% of their scalp hair coverage at baseline. At week 24, more than 30% of patients taking deuruxolitinib experiencing 80% or more scalp hair coverage (SALT score ≤ 20). Also, up to 25% of patients had almost all of their scalp hair back at 24 weeks (≥ 90% coverage).



In terms of safety, the data showed that 3.1% of patients who received deuruxolitinib 8 mg twice daily in the phase 2 dose-ranging study and phase 3 randomized placebo-controlled trials discontinued treatment owing to adverse reactions. The three most common adverse events in placebo-controlled trials were headache (12.4% vs 9.4% with placebo), acne (10% vs 4.3% with placebo), and nasopharyngitis (8.1% vs 6.7% with placebo). More than 100 people continued taking deuruxolitinib for more than 3 years.

Deuruxolitinib is the third treatment and third JAK inhibitor approved by the FDA for severe alopecia areata. Baricitinib (Olumiant) was approved in June 2022 for adults with alopecia areata, followed by ritlecitinib (Litfulo) approved in June 2023 for patients aged 12 years and older. 

In a statement from the National Alopecia Areata Foundation (NAAF), Nicole Friedland, NAAF’s president and CEO, said that “it is with tremendous excitement that we welcome the FDA’s approval of a third treatment for severe alopecia areata in as many years.”

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

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Pilot Study Finds Experimental CBD Cream Decreases UVA Skin Damage

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Mon, 07/29/2024 - 15:05

Application of an investigative topical cannabidiol (CBD) cream to buttock skin demonstrated protective properties against ultraviolet A (UVA) radiation-induced DNA and mitochondrial DNA damage, results from a small prospective pilot study showed.

“This study hopefully reinvigorates interest in the utilization of whether it be plant-based, human-derived, or synthetic cannabinoids in the management of dermatologic disease,” one of the study investigators, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization. The study was published in the Journal of the American Academy of Dermatology.

George Washington University
Dr. Adam Friedman

For the prospective, single-center, pilot trial, which is believed to be the first of its kind, 19 volunteers aged 22-65 with Fitzpatrick skin types I-III applied either a nano-encapsulated CBD cream or a vehicle cream to blind spots on the skin of the buttocks twice daily for 14 days. Next, researchers applied a minimal erythema dose of UV radiation to the treated skin areas for 30 minutes. After 24 hours, they visually inspected the treated areas to clinically compare the erythema. They also performed five 4-mm punch biopsies from UVA- and non-UVA–exposed treatment sites on each buttock, as well as from an untreated control site that was at least 5 cm away from the treated left buttock.

At 24 hours, 21% of study participants showed less redness on CBD-treated skin compared with control-treated skin, while histology showed that CBD-treated skin demonstrated reduced UVA-induced epidermal hyperplasia compared with control-treated skin (a mean 11.3% change from baseline vs 28.7%, respectively; P = .01). In other findings, application of CBD cream reduced DNA damage and DNA mutations associated with UVA-induced skin aging/damage and ultimately skin cancer.

In addition, the CBD-treated skin samples had a reduction in the UVA-associated increase in the premutagenic marker 8-oxoguanine DNA glycosylase 1 and a reduction of two major UVA-induced mitochondrial DNA deletions associated with skin photoaging.

The research, Dr. Friedman noted, “took a village of collaborators and almost 3 years to pull together,” including collaborating with his long-standing mentor, Brian Berman, MD, PhD, professor emeritus of dermatology and dermatologic surgery at the University of Miami, Coral Gables, Florida, and a study coauthor. The study “demonstrated that purposeful delivery of CBD using an established nanoparticle platform ... can have a quantifiable impact on preventing the expected DNA damage and cellular injury one should see from UVA exposure,” said Dr. Friedman, who codeveloped the nanoparticle platform with his father, Joel M. Friedman, MD, PhD, professor of microbiology and immunology at Albert Einstein College of Medicine, New York City.



“Never before has a dermatologic study on topical cannabinoids dove so deeply into the biological impact of this natural ingredient to highlight its potential, here, as a mitigation strategy for unprotected exposure to prevent the downstream sequelae of UV radiation,” Dr. Friedman said.

In the paper, he and his coauthors acknowledged certain limitations of their study, including its small sample size and the single-center design.

Dr. Friedman disclosed that he coinvented the nanoparticle technology used in the trial. Dr. Berman is a consultant at MINO Labs, which funded the study. The remaining authors had no disclosures. The study was done in collaboration with the Center for Clinical and Cosmetic Research in Aventura, Florida.

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

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Application of an investigative topical cannabidiol (CBD) cream to buttock skin demonstrated protective properties against ultraviolet A (UVA) radiation-induced DNA and mitochondrial DNA damage, results from a small prospective pilot study showed.

“This study hopefully reinvigorates interest in the utilization of whether it be plant-based, human-derived, or synthetic cannabinoids in the management of dermatologic disease,” one of the study investigators, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization. The study was published in the Journal of the American Academy of Dermatology.

George Washington University
Dr. Adam Friedman

For the prospective, single-center, pilot trial, which is believed to be the first of its kind, 19 volunteers aged 22-65 with Fitzpatrick skin types I-III applied either a nano-encapsulated CBD cream or a vehicle cream to blind spots on the skin of the buttocks twice daily for 14 days. Next, researchers applied a minimal erythema dose of UV radiation to the treated skin areas for 30 minutes. After 24 hours, they visually inspected the treated areas to clinically compare the erythema. They also performed five 4-mm punch biopsies from UVA- and non-UVA–exposed treatment sites on each buttock, as well as from an untreated control site that was at least 5 cm away from the treated left buttock.

At 24 hours, 21% of study participants showed less redness on CBD-treated skin compared with control-treated skin, while histology showed that CBD-treated skin demonstrated reduced UVA-induced epidermal hyperplasia compared with control-treated skin (a mean 11.3% change from baseline vs 28.7%, respectively; P = .01). In other findings, application of CBD cream reduced DNA damage and DNA mutations associated with UVA-induced skin aging/damage and ultimately skin cancer.

In addition, the CBD-treated skin samples had a reduction in the UVA-associated increase in the premutagenic marker 8-oxoguanine DNA glycosylase 1 and a reduction of two major UVA-induced mitochondrial DNA deletions associated with skin photoaging.

The research, Dr. Friedman noted, “took a village of collaborators and almost 3 years to pull together,” including collaborating with his long-standing mentor, Brian Berman, MD, PhD, professor emeritus of dermatology and dermatologic surgery at the University of Miami, Coral Gables, Florida, and a study coauthor. The study “demonstrated that purposeful delivery of CBD using an established nanoparticle platform ... can have a quantifiable impact on preventing the expected DNA damage and cellular injury one should see from UVA exposure,” said Dr. Friedman, who codeveloped the nanoparticle platform with his father, Joel M. Friedman, MD, PhD, professor of microbiology and immunology at Albert Einstein College of Medicine, New York City.



“Never before has a dermatologic study on topical cannabinoids dove so deeply into the biological impact of this natural ingredient to highlight its potential, here, as a mitigation strategy for unprotected exposure to prevent the downstream sequelae of UV radiation,” Dr. Friedman said.

In the paper, he and his coauthors acknowledged certain limitations of their study, including its small sample size and the single-center design.

Dr. Friedman disclosed that he coinvented the nanoparticle technology used in the trial. Dr. Berman is a consultant at MINO Labs, which funded the study. The remaining authors had no disclosures. The study was done in collaboration with the Center for Clinical and Cosmetic Research in Aventura, Florida.

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

Application of an investigative topical cannabidiol (CBD) cream to buttock skin demonstrated protective properties against ultraviolet A (UVA) radiation-induced DNA and mitochondrial DNA damage, results from a small prospective pilot study showed.

“This study hopefully reinvigorates interest in the utilization of whether it be plant-based, human-derived, or synthetic cannabinoids in the management of dermatologic disease,” one of the study investigators, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization. The study was published in the Journal of the American Academy of Dermatology.

George Washington University
Dr. Adam Friedman

For the prospective, single-center, pilot trial, which is believed to be the first of its kind, 19 volunteers aged 22-65 with Fitzpatrick skin types I-III applied either a nano-encapsulated CBD cream or a vehicle cream to blind spots on the skin of the buttocks twice daily for 14 days. Next, researchers applied a minimal erythema dose of UV radiation to the treated skin areas for 30 minutes. After 24 hours, they visually inspected the treated areas to clinically compare the erythema. They also performed five 4-mm punch biopsies from UVA- and non-UVA–exposed treatment sites on each buttock, as well as from an untreated control site that was at least 5 cm away from the treated left buttock.

At 24 hours, 21% of study participants showed less redness on CBD-treated skin compared with control-treated skin, while histology showed that CBD-treated skin demonstrated reduced UVA-induced epidermal hyperplasia compared with control-treated skin (a mean 11.3% change from baseline vs 28.7%, respectively; P = .01). In other findings, application of CBD cream reduced DNA damage and DNA mutations associated with UVA-induced skin aging/damage and ultimately skin cancer.

In addition, the CBD-treated skin samples had a reduction in the UVA-associated increase in the premutagenic marker 8-oxoguanine DNA glycosylase 1 and a reduction of two major UVA-induced mitochondrial DNA deletions associated with skin photoaging.

The research, Dr. Friedman noted, “took a village of collaborators and almost 3 years to pull together,” including collaborating with his long-standing mentor, Brian Berman, MD, PhD, professor emeritus of dermatology and dermatologic surgery at the University of Miami, Coral Gables, Florida, and a study coauthor. The study “demonstrated that purposeful delivery of CBD using an established nanoparticle platform ... can have a quantifiable impact on preventing the expected DNA damage and cellular injury one should see from UVA exposure,” said Dr. Friedman, who codeveloped the nanoparticle platform with his father, Joel M. Friedman, MD, PhD, professor of microbiology and immunology at Albert Einstein College of Medicine, New York City.



“Never before has a dermatologic study on topical cannabinoids dove so deeply into the biological impact of this natural ingredient to highlight its potential, here, as a mitigation strategy for unprotected exposure to prevent the downstream sequelae of UV radiation,” Dr. Friedman said.

In the paper, he and his coauthors acknowledged certain limitations of their study, including its small sample size and the single-center design.

Dr. Friedman disclosed that he coinvented the nanoparticle technology used in the trial. Dr. Berman is a consultant at MINO Labs, which funded the study. The remaining authors had no disclosures. The study was done in collaboration with the Center for Clinical and Cosmetic Research in Aventura, Florida.

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

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FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

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Gluconolactone

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Changed
Fri, 07/26/2024 - 15:37

 

Gluconolactone, 3,4,5-trihydroxy-6-(hydroxymethyl) oxan-2-one (C6H10O6), is known to display antioxidant, moisturizing, and soothing activity as well as enhance skin barrier function and protect elastin fibers from UV-engendered damage.1 This derivative of oxidized glucose lactone is present naturally in bread, cheese, fruit juices, honey, tofu, and wine, and is used as a food additive in Europe.1,2 In dermatology, it is most often used in chemical peels.

Polyhydroxy acids (PHAs) were discovered about 3 decades ago to exert similar functions as alpha hydroxy acids without provoking sensory irritation reactions. Gluconolactone along with lactobionic acid were the identified PHAs and further characterized as delivering more humectant and moisturizing activity than alpha hydroxy acids and effective in combination with retinoic acid to treat adult acne and with retinyl acetate to confer antiaging benefits.3 It is typically added to products for its skin-conditioning qualities, resulting in smoother, brighter, more toned skin.4 This column focuses on recent studies using this bioactive agent for dermatologic purposes.
 

Split-Face Studies Show Various Benefits

peepo/E+/Getty Images

In 2023, Jarząbek-Perz and colleagues conducted a split-face evaluation to assess the effects on various skin parameters (ie, hydration, pH, sebum, and transepidermal water loss [TEWL]) of gluconolactone and oxybrasion, compared with gluconolactone and microneedling. Twenty-one White women underwent a series of three split-face treatments at 1-week intervals. Chemical peels with 10% gluconolactone were performed on the whole face. The right side of the face was also treated with oxybrasion and the left with microneedle mesotherapy. Skin parameters were measured before the first and third treatments and 2 weeks following the final treatment. Photos were taken before and after the study. Both treatments resulted in improved hydration and reductions in sebum, pH, and TEWL. No statistically significant differences were noted between the treatment protocols. The researchers concluded that gluconolactone peels can be effectively combined with oxybrasion or microneedle mesotherapy to enhance skin hydration and to secure the hydrolipid barrier.5

Later that year, the same team evaluated pH, sebum levels, and TEWL before, during, and after several applications of 10% and 30% gluconolactone chemical peels in a split-face model in 16 female participants. The investigators conducted three procedures on both sides of the face, taking measurements on the forehead, periorbital area, on the cheek, and on the nose wing before, during, and 7 days after the final treatment. They found statistically significant improvements in sebum levels in the cheeks after the treatment series. Also, pH values were lower at each measurement site after each procedure. TEWL levels were significantly diminished around the eyes, as well as the left forehead and right cheek, with no significant discrepancy between gluconolactone concentrations. The researchers concluded that gluconolactone plays a major role in reducing cutaneous pH and TEWL and imparts a regulatory effect on sebum.1

Two years earlier, Jarząbek-Perz and colleagues assessed skin moisture in a split-face model in 16 healthy women after the application of 10% and 30% gluconolactone. Investigators measured skin moisture before and after each of three treatments and a week after the final treatment from the forehead, periorbital area, and on the cheek. They observed no significant discrepancies between the 10% and 30% formulations, but a significant elevation in facial skin hydration was found to be promoted by gluconolactone. The investigators concluded that gluconolactone is an effective moisturizer for care of dry skin.6

Topical Formulation

In 2023, Zerbinati and colleagues determined that a gluconolactone-based lotion that they had begun testing 2 years earlier was safe and effective for dermatologic applications, with the noncomedogenic formulation found suitable as an antiaging agent, particularly as it treats aging-related pore dilatation.7,8

Acne Treatment

In 2019, Kantikosum and colleagues conducted a double-blind, within-person comparative study to assess the efficacy of various cosmeceutical ingredients, including gluconolactone, glycolic acid, licochalcone A, and salicylic acid, combined with the acne treatment adapalene vs adapalene monotherapy for mild to moderate acne. Each of 25 subjects over 28 days applied a product mixed with 0.1% adapalene on one side of the face, and 0.1% adapalene alone on the other side of the face once nightly. The VISIA camera system spot score pointed to a statistically significant improvement on the combination sides. Differences in lesion reduction and severity were within acceptable margins, the authors reported. They concluded that the cosmeceutical combinations yielded similar benefits as adapalene alone, with the combination formulations decreasing acne complications.9

Potential Use as an Antifibrotic Agent

Baumann Cosmetic & Research Institute
Dr. Leslie S. Baumann

In 2018, Jayamani and colleagues investigated the antifibrotic characteristics of glucono-delta-lactone, a known acidifier, to ascertain if it could directly suppress collagen fibrils or even cause them to disintegrate. The researchers noted that collagen fibrillation is pH dependent, and that glucono-delta-lactone was found to exert a concentration-dependent suppression of fibrils and disintegration of preformed collagen fibrils with the antifibrotic function of the compound ascribed to its capacity to decrease pH. Further, glucono-delta-lactone appeared to emerge as an ideal antifibrotic agent as it left intact the triple helical structure of collagen after treatment. The investigators concluded that glucono-delta-lactone provides the foundation for developing antifibrotic agents intended to treat disorders characterized by collagen deposition.10

Conclusion

Gluconolactone emerged in the 1990s as a PHA useful in skin peels as an alternative to alpha hydroxy acids because of its nonirritating qualities. Since then, its soothing, hydrating, and, in particular, antiacne and antiaging qualities have become established. Wider applications of this versatile agent for dermatologic purposes are likely to be further investigated.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as a ecommerce solution. Write to her at [email protected].

References

1. Jarząbek-Perz S et al. J Cosmet Dermatol. 2023 Dec;22(12):3305-3312..

2. Qin X et al. Front Physiol. 2022 Mar 14;13:856699.

3. Grimes PE et al. Cutis. 2004 Feb;73(2 Suppl):3-13.

4. Glaser DA. Facial Plast Surg Clin North Am. 2003 May;11(2):219-227.

5. Jarząbek-Perz S et al. Skin Res Technol. 2023 Jun;29(6):e13353.

6. Jarząbek-Perz S et al. Skin Res Technol. 2021 Sep;27(5):925-930.

7. Zerbinati N et al. Molecules. 2021 Dec 15;26(24):7592.

8. Zerbinati Net al. Pharmaceuticals (Basel). 2023 Apr 27;16(5):655.

9. Kantikosum K et al. Clin Cosmet Investig Dermatol. 2019 Feb 19;12:151-161.

10. Jayamani J et al. Int J Biol Macromol. 2018 Feb;107(Pt A):175-185.

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Gluconolactone, 3,4,5-trihydroxy-6-(hydroxymethyl) oxan-2-one (C6H10O6), is known to display antioxidant, moisturizing, and soothing activity as well as enhance skin barrier function and protect elastin fibers from UV-engendered damage.1 This derivative of oxidized glucose lactone is present naturally in bread, cheese, fruit juices, honey, tofu, and wine, and is used as a food additive in Europe.1,2 In dermatology, it is most often used in chemical peels.

Polyhydroxy acids (PHAs) were discovered about 3 decades ago to exert similar functions as alpha hydroxy acids without provoking sensory irritation reactions. Gluconolactone along with lactobionic acid were the identified PHAs and further characterized as delivering more humectant and moisturizing activity than alpha hydroxy acids and effective in combination with retinoic acid to treat adult acne and with retinyl acetate to confer antiaging benefits.3 It is typically added to products for its skin-conditioning qualities, resulting in smoother, brighter, more toned skin.4 This column focuses on recent studies using this bioactive agent for dermatologic purposes.
 

Split-Face Studies Show Various Benefits

peepo/E+/Getty Images

In 2023, Jarząbek-Perz and colleagues conducted a split-face evaluation to assess the effects on various skin parameters (ie, hydration, pH, sebum, and transepidermal water loss [TEWL]) of gluconolactone and oxybrasion, compared with gluconolactone and microneedling. Twenty-one White women underwent a series of three split-face treatments at 1-week intervals. Chemical peels with 10% gluconolactone were performed on the whole face. The right side of the face was also treated with oxybrasion and the left with microneedle mesotherapy. Skin parameters were measured before the first and third treatments and 2 weeks following the final treatment. Photos were taken before and after the study. Both treatments resulted in improved hydration and reductions in sebum, pH, and TEWL. No statistically significant differences were noted between the treatment protocols. The researchers concluded that gluconolactone peels can be effectively combined with oxybrasion or microneedle mesotherapy to enhance skin hydration and to secure the hydrolipid barrier.5

Later that year, the same team evaluated pH, sebum levels, and TEWL before, during, and after several applications of 10% and 30% gluconolactone chemical peels in a split-face model in 16 female participants. The investigators conducted three procedures on both sides of the face, taking measurements on the forehead, periorbital area, on the cheek, and on the nose wing before, during, and 7 days after the final treatment. They found statistically significant improvements in sebum levels in the cheeks after the treatment series. Also, pH values were lower at each measurement site after each procedure. TEWL levels were significantly diminished around the eyes, as well as the left forehead and right cheek, with no significant discrepancy between gluconolactone concentrations. The researchers concluded that gluconolactone plays a major role in reducing cutaneous pH and TEWL and imparts a regulatory effect on sebum.1

Two years earlier, Jarząbek-Perz and colleagues assessed skin moisture in a split-face model in 16 healthy women after the application of 10% and 30% gluconolactone. Investigators measured skin moisture before and after each of three treatments and a week after the final treatment from the forehead, periorbital area, and on the cheek. They observed no significant discrepancies between the 10% and 30% formulations, but a significant elevation in facial skin hydration was found to be promoted by gluconolactone. The investigators concluded that gluconolactone is an effective moisturizer for care of dry skin.6

Topical Formulation

In 2023, Zerbinati and colleagues determined that a gluconolactone-based lotion that they had begun testing 2 years earlier was safe and effective for dermatologic applications, with the noncomedogenic formulation found suitable as an antiaging agent, particularly as it treats aging-related pore dilatation.7,8

Acne Treatment

In 2019, Kantikosum and colleagues conducted a double-blind, within-person comparative study to assess the efficacy of various cosmeceutical ingredients, including gluconolactone, glycolic acid, licochalcone A, and salicylic acid, combined with the acne treatment adapalene vs adapalene monotherapy for mild to moderate acne. Each of 25 subjects over 28 days applied a product mixed with 0.1% adapalene on one side of the face, and 0.1% adapalene alone on the other side of the face once nightly. The VISIA camera system spot score pointed to a statistically significant improvement on the combination sides. Differences in lesion reduction and severity were within acceptable margins, the authors reported. They concluded that the cosmeceutical combinations yielded similar benefits as adapalene alone, with the combination formulations decreasing acne complications.9

Potential Use as an Antifibrotic Agent

Baumann Cosmetic & Research Institute
Dr. Leslie S. Baumann

In 2018, Jayamani and colleagues investigated the antifibrotic characteristics of glucono-delta-lactone, a known acidifier, to ascertain if it could directly suppress collagen fibrils or even cause them to disintegrate. The researchers noted that collagen fibrillation is pH dependent, and that glucono-delta-lactone was found to exert a concentration-dependent suppression of fibrils and disintegration of preformed collagen fibrils with the antifibrotic function of the compound ascribed to its capacity to decrease pH. Further, glucono-delta-lactone appeared to emerge as an ideal antifibrotic agent as it left intact the triple helical structure of collagen after treatment. The investigators concluded that glucono-delta-lactone provides the foundation for developing antifibrotic agents intended to treat disorders characterized by collagen deposition.10

Conclusion

Gluconolactone emerged in the 1990s as a PHA useful in skin peels as an alternative to alpha hydroxy acids because of its nonirritating qualities. Since then, its soothing, hydrating, and, in particular, antiacne and antiaging qualities have become established. Wider applications of this versatile agent for dermatologic purposes are likely to be further investigated.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as a ecommerce solution. Write to her at [email protected].

References

1. Jarząbek-Perz S et al. J Cosmet Dermatol. 2023 Dec;22(12):3305-3312..

2. Qin X et al. Front Physiol. 2022 Mar 14;13:856699.

3. Grimes PE et al. Cutis. 2004 Feb;73(2 Suppl):3-13.

4. Glaser DA. Facial Plast Surg Clin North Am. 2003 May;11(2):219-227.

5. Jarząbek-Perz S et al. Skin Res Technol. 2023 Jun;29(6):e13353.

6. Jarząbek-Perz S et al. Skin Res Technol. 2021 Sep;27(5):925-930.

7. Zerbinati N et al. Molecules. 2021 Dec 15;26(24):7592.

8. Zerbinati Net al. Pharmaceuticals (Basel). 2023 Apr 27;16(5):655.

9. Kantikosum K et al. Clin Cosmet Investig Dermatol. 2019 Feb 19;12:151-161.

10. Jayamani J et al. Int J Biol Macromol. 2018 Feb;107(Pt A):175-185.

 

Gluconolactone, 3,4,5-trihydroxy-6-(hydroxymethyl) oxan-2-one (C6H10O6), is known to display antioxidant, moisturizing, and soothing activity as well as enhance skin barrier function and protect elastin fibers from UV-engendered damage.1 This derivative of oxidized glucose lactone is present naturally in bread, cheese, fruit juices, honey, tofu, and wine, and is used as a food additive in Europe.1,2 In dermatology, it is most often used in chemical peels.

Polyhydroxy acids (PHAs) were discovered about 3 decades ago to exert similar functions as alpha hydroxy acids without provoking sensory irritation reactions. Gluconolactone along with lactobionic acid were the identified PHAs and further characterized as delivering more humectant and moisturizing activity than alpha hydroxy acids and effective in combination with retinoic acid to treat adult acne and with retinyl acetate to confer antiaging benefits.3 It is typically added to products for its skin-conditioning qualities, resulting in smoother, brighter, more toned skin.4 This column focuses on recent studies using this bioactive agent for dermatologic purposes.
 

Split-Face Studies Show Various Benefits

peepo/E+/Getty Images

In 2023, Jarząbek-Perz and colleagues conducted a split-face evaluation to assess the effects on various skin parameters (ie, hydration, pH, sebum, and transepidermal water loss [TEWL]) of gluconolactone and oxybrasion, compared with gluconolactone and microneedling. Twenty-one White women underwent a series of three split-face treatments at 1-week intervals. Chemical peels with 10% gluconolactone were performed on the whole face. The right side of the face was also treated with oxybrasion and the left with microneedle mesotherapy. Skin parameters were measured before the first and third treatments and 2 weeks following the final treatment. Photos were taken before and after the study. Both treatments resulted in improved hydration and reductions in sebum, pH, and TEWL. No statistically significant differences were noted between the treatment protocols. The researchers concluded that gluconolactone peels can be effectively combined with oxybrasion or microneedle mesotherapy to enhance skin hydration and to secure the hydrolipid barrier.5

Later that year, the same team evaluated pH, sebum levels, and TEWL before, during, and after several applications of 10% and 30% gluconolactone chemical peels in a split-face model in 16 female participants. The investigators conducted three procedures on both sides of the face, taking measurements on the forehead, periorbital area, on the cheek, and on the nose wing before, during, and 7 days after the final treatment. They found statistically significant improvements in sebum levels in the cheeks after the treatment series. Also, pH values were lower at each measurement site after each procedure. TEWL levels were significantly diminished around the eyes, as well as the left forehead and right cheek, with no significant discrepancy between gluconolactone concentrations. The researchers concluded that gluconolactone plays a major role in reducing cutaneous pH and TEWL and imparts a regulatory effect on sebum.1

Two years earlier, Jarząbek-Perz and colleagues assessed skin moisture in a split-face model in 16 healthy women after the application of 10% and 30% gluconolactone. Investigators measured skin moisture before and after each of three treatments and a week after the final treatment from the forehead, periorbital area, and on the cheek. They observed no significant discrepancies between the 10% and 30% formulations, but a significant elevation in facial skin hydration was found to be promoted by gluconolactone. The investigators concluded that gluconolactone is an effective moisturizer for care of dry skin.6

Topical Formulation

In 2023, Zerbinati and colleagues determined that a gluconolactone-based lotion that they had begun testing 2 years earlier was safe and effective for dermatologic applications, with the noncomedogenic formulation found suitable as an antiaging agent, particularly as it treats aging-related pore dilatation.7,8

Acne Treatment

In 2019, Kantikosum and colleagues conducted a double-blind, within-person comparative study to assess the efficacy of various cosmeceutical ingredients, including gluconolactone, glycolic acid, licochalcone A, and salicylic acid, combined with the acne treatment adapalene vs adapalene monotherapy for mild to moderate acne. Each of 25 subjects over 28 days applied a product mixed with 0.1% adapalene on one side of the face, and 0.1% adapalene alone on the other side of the face once nightly. The VISIA camera system spot score pointed to a statistically significant improvement on the combination sides. Differences in lesion reduction and severity were within acceptable margins, the authors reported. They concluded that the cosmeceutical combinations yielded similar benefits as adapalene alone, with the combination formulations decreasing acne complications.9

Potential Use as an Antifibrotic Agent

Baumann Cosmetic & Research Institute
Dr. Leslie S. Baumann

In 2018, Jayamani and colleagues investigated the antifibrotic characteristics of glucono-delta-lactone, a known acidifier, to ascertain if it could directly suppress collagen fibrils or even cause them to disintegrate. The researchers noted that collagen fibrillation is pH dependent, and that glucono-delta-lactone was found to exert a concentration-dependent suppression of fibrils and disintegration of preformed collagen fibrils with the antifibrotic function of the compound ascribed to its capacity to decrease pH. Further, glucono-delta-lactone appeared to emerge as an ideal antifibrotic agent as it left intact the triple helical structure of collagen after treatment. The investigators concluded that glucono-delta-lactone provides the foundation for developing antifibrotic agents intended to treat disorders characterized by collagen deposition.10

Conclusion

Gluconolactone emerged in the 1990s as a PHA useful in skin peels as an alternative to alpha hydroxy acids because of its nonirritating qualities. Since then, its soothing, hydrating, and, in particular, antiacne and antiaging qualities have become established. Wider applications of this versatile agent for dermatologic purposes are likely to be further investigated.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as a ecommerce solution. Write to her at [email protected].

References

1. Jarząbek-Perz S et al. J Cosmet Dermatol. 2023 Dec;22(12):3305-3312..

2. Qin X et al. Front Physiol. 2022 Mar 14;13:856699.

3. Grimes PE et al. Cutis. 2004 Feb;73(2 Suppl):3-13.

4. Glaser DA. Facial Plast Surg Clin North Am. 2003 May;11(2):219-227.

5. Jarząbek-Perz S et al. Skin Res Technol. 2023 Jun;29(6):e13353.

6. Jarząbek-Perz S et al. Skin Res Technol. 2021 Sep;27(5):925-930.

7. Zerbinati N et al. Molecules. 2021 Dec 15;26(24):7592.

8. Zerbinati Net al. Pharmaceuticals (Basel). 2023 Apr 27;16(5):655.

9. Kantikosum K et al. Clin Cosmet Investig Dermatol. 2019 Feb 19;12:151-161.

10. Jayamani J et al. Int J Biol Macromol. 2018 Feb;107(Pt A):175-185.

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Study Finds Differences in Side Effect Profiles With Two Oral Psoriasis Therapies

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Changed
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TOPLINE:

More gastrointestinal and nervous symptom adverse events (AEs) are linked to apremilast than deucravacitinib, which is associated with more cutaneous AEs, according to a retrospective comparison using US Food and Drug Administration (FDA) data.

METHODOLOGY:

  • To evaluate the adverse events associated with apremilast, an oral phosphodiesterase-4 (PDE4) inhibitor, and deucravacitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, data were drawn from the FDA’s Adverse Event Reporting System database.
  • The Medex_UIMA_1.8.3 system was used to standardize drug names, and MedDRA terminology was used to encode, categorize, and localize signals.
  • AE event signals were grouped by skin and subcutaneous tissue disorders, gastrointestinal disorders, infections and infestations, and nervous system disorders.

TAKEAWAY:

  • There were 95,734 AE reports for apremilast and 760 AE reports for deucravacitinib, and AEs were found to be significant over time.
  • The more common cutaneous AEs were psoriasis recurrence and acne (associated with apremilast) and skin burning and erythema (associated with deucravacitinib).
  • The more common gastrointestinal AEs were diarrhea and nausea (apremilast) and mouth ulceration (deucravacitinib).
  • Deucravacitinib-related pruritus and rash, as well as apremilast-related tension headache, were more common in women than men; deucravacitinib-related skin burning was more common in men.

IN PRACTICE:

The results “can help the doctors to choose the right treatment options based on the baseline characteristics of different patients,” said Yuanyuan Xu, a graduate student in the Department of Dermatology, Sichuan University, Chengdu, China.

SOURCE:

Mr. Xu presented the study as a poster at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2024 annual meeting.

LIMITATIONS:

The study was retrospective and cannot prove causality, and there were far fewer AE reports related to deucravacitinib, likely because the drug was introduced more recently.

DISCLOSURES:

The study received no funding, and the authors had no relevant financial disclosures.

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

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TOPLINE:

More gastrointestinal and nervous symptom adverse events (AEs) are linked to apremilast than deucravacitinib, which is associated with more cutaneous AEs, according to a retrospective comparison using US Food and Drug Administration (FDA) data.

METHODOLOGY:

  • To evaluate the adverse events associated with apremilast, an oral phosphodiesterase-4 (PDE4) inhibitor, and deucravacitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, data were drawn from the FDA’s Adverse Event Reporting System database.
  • The Medex_UIMA_1.8.3 system was used to standardize drug names, and MedDRA terminology was used to encode, categorize, and localize signals.
  • AE event signals were grouped by skin and subcutaneous tissue disorders, gastrointestinal disorders, infections and infestations, and nervous system disorders.

TAKEAWAY:

  • There were 95,734 AE reports for apremilast and 760 AE reports for deucravacitinib, and AEs were found to be significant over time.
  • The more common cutaneous AEs were psoriasis recurrence and acne (associated with apremilast) and skin burning and erythema (associated with deucravacitinib).
  • The more common gastrointestinal AEs were diarrhea and nausea (apremilast) and mouth ulceration (deucravacitinib).
  • Deucravacitinib-related pruritus and rash, as well as apremilast-related tension headache, were more common in women than men; deucravacitinib-related skin burning was more common in men.

IN PRACTICE:

The results “can help the doctors to choose the right treatment options based on the baseline characteristics of different patients,” said Yuanyuan Xu, a graduate student in the Department of Dermatology, Sichuan University, Chengdu, China.

SOURCE:

Mr. Xu presented the study as a poster at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2024 annual meeting.

LIMITATIONS:

The study was retrospective and cannot prove causality, and there were far fewer AE reports related to deucravacitinib, likely because the drug was introduced more recently.

DISCLOSURES:

The study received no funding, and the authors had no relevant financial disclosures.

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

 

TOPLINE:

More gastrointestinal and nervous symptom adverse events (AEs) are linked to apremilast than deucravacitinib, which is associated with more cutaneous AEs, according to a retrospective comparison using US Food and Drug Administration (FDA) data.

METHODOLOGY:

  • To evaluate the adverse events associated with apremilast, an oral phosphodiesterase-4 (PDE4) inhibitor, and deucravacitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, data were drawn from the FDA’s Adverse Event Reporting System database.
  • The Medex_UIMA_1.8.3 system was used to standardize drug names, and MedDRA terminology was used to encode, categorize, and localize signals.
  • AE event signals were grouped by skin and subcutaneous tissue disorders, gastrointestinal disorders, infections and infestations, and nervous system disorders.

TAKEAWAY:

  • There were 95,734 AE reports for apremilast and 760 AE reports for deucravacitinib, and AEs were found to be significant over time.
  • The more common cutaneous AEs were psoriasis recurrence and acne (associated with apremilast) and skin burning and erythema (associated with deucravacitinib).
  • The more common gastrointestinal AEs were diarrhea and nausea (apremilast) and mouth ulceration (deucravacitinib).
  • Deucravacitinib-related pruritus and rash, as well as apremilast-related tension headache, were more common in women than men; deucravacitinib-related skin burning was more common in men.

IN PRACTICE:

The results “can help the doctors to choose the right treatment options based on the baseline characteristics of different patients,” said Yuanyuan Xu, a graduate student in the Department of Dermatology, Sichuan University, Chengdu, China.

SOURCE:

Mr. Xu presented the study as a poster at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2024 annual meeting.

LIMITATIONS:

The study was retrospective and cannot prove causality, and there were far fewer AE reports related to deucravacitinib, likely because the drug was introduced more recently.

DISCLOSURES:

The study received no funding, and the authors had no relevant financial disclosures.

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

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