Dermatology

An influential Nature paper predicted in 2017 that advances in artificial intelligence (AI) could unleash remarkable changes in dermatology, such as using phones to help detect skin cancer earlier.

Given that about 6.3 billion smartphones would soon be in use, this AI approach could provide a gateway for “low-cost universal access to vital diagnostic care,” wrote Justin M. Ko, MD, MBA, a dermatologist, and colleagues from Stanford (Calif.) University that included other dermatologists and engineers.

Dr. Ko and his coauthors described how they trained a computer system to identify both benign and cancerous skin lesions. They used an approach known as a convolutional neural network, often deployed for projects seeking to train computers to “see” through image analysis. They said that their test of this system found it to be on par with the performance of 21 board-certified dermatologists.

“This fast, scalable method is deployable on mobile devices and holds the potential for substantial clinical impact, including broadening the scope of primary care practice and augmenting clinical decision-making for dermatology specialists,” they wrote in their paper.

More than 6 years later, there are signs that companies are making progress toward moving skin checks using this technology into U.S. primary care settings – but only with devices that employ special tools.

It may prove tougher for companies to eventually secure the sign-off of the U.S. Food and Drug Administration for mobile apps intended to let consumers handle this task with smartphones.

Such tools would need to be proven highly accurate before release, because too many false positives mean that people would be needlessly exposed to biopsies, said Sancy A. Leachman, MD, PhD, director of the melanoma research program and chair of the department of dermatology at Oregon Health & Science University, Portland.

And false-negative readings would allow melanoma to advance and even be fatal, Dr. Leachman told this news organization.

Roxana Daneshjou, MD, PhD, a dermatologist at Stanford who has studied the promise and the pitfalls of AI in medicine, said that developers of a consumer skin-check app would need to know how people would react to their readings. That includes a good sense of how often they would appropriately seek medical care for a concerning reading. (She was not an author of the previously cited Nature paper but has published widely on AI.)

Christopher Smith

“The direct-to-consumer diagnostic space makes me nervous,” Dr. Daneshjou said in an interview. “In order to do it, you really need to have good studies in consumer populations prior to release. You need to show how effective it is with follow up.”
 

FDA shows interest – and reservations

As of July, the FDA had not yet given its okay for marketing of any consumer apps intended to help people detect signs of skin cancer, an agency spokesperson told this news organization.

To date, the agency has only cleared two AI-based products for this task, both meant to be used by dermatologists. And only one of these two products, Scibase’s Nevisense, remains in use in the United States. The other, MelaFind, has been discontinued. In 2017, Strata Skin Sciences said that the product did not win “a significant enough level of acceptance by dermatologists to justify the continued investment” in it. And the company said it notified the 90 owners of MelaFind devices in the United States that it would no longer support the device.

But another company, DermaSensor, said in a 2021 press release that it expects its AI-powered tool, also named DermaSensor, to be the “first ever FDA cleared or approved skin cancer detection device for primary care providers.”

The Miami-based firm said that the FDA had granted its product a “breakthrough” device designation. A breakthrough designation means that agency staff will offer extra help and guidance to companies in developing a product, because of its expected benefit for patients.

In a 2020 press release, 3Derm Systems, now owned by Digital Diagnostics, made a similar announcement about winning FDA breakthrough designation for an AI-powered tool intended to allow skin checks in primary care settings.

(The FDA generally does not comment on its reviews of experimental drugs and devices, but companies can do so. Several other companies have announced FDA breakthrough designations for AI-driven products intended to check for skin lesions, but these might be used in settings other than primary care.)

Both DermaSensor and Digital Diagnostics have chairs with notable track records for winning FDA approvals of other devices. DermaSensor’s Maurice Ferre, MD, also is the chairman of Insightec, which in 2016 won the first FDA approval for a device with a breakthrough designation device that uses ultrasound to treat tremors.

In 2018, the FDA allowed Digital Diagnostics, then called IDx, to introduce in the United States the first medical device using AI in primary care offices to check for signs of diabetic retinopathy. This product also had an FDA breakthrough designation. The executive chairman and founder of Digital Diagnostics is Michael Abramoff, MD, PhD, professor of engineering and ophthalmology at the University of Iowa, Iowa City. Dr. Abramoff and the team behind the AI tool for retinopathy, now called the LumineticsCore system, also scored a notable win with Medicare, which agreed to cover use of the product through a dedicated CPT code.
 

FDA draft guidance

The FDA has acknowledged the interest in broadening access to skin checks via AI.

This was a topic of discussion at a 2-day advisory committee meeting the FDA held last year. In April 2023, the FDA outlined some of its expectations for future regulation of skin-analyzing tools as part of a wide-ranging draft guidance document intended to aid companies in their efforts to develop products using a form of AI known as machine learning.

In the document, the FDA described how it might approach applications for “hypothetical” devices using this kind of AI, such as a special tool to help primary care clinicians identify lesions in need of further investigation. Such a product would use a specific camera for gathering data for its initial clearance, in the FDA’s hypothetical scenario.

The FDA staff offered technical suggestions about what the developer of this hypothetical device would have to do to extend its use to smartphones and tablets while keeping clinicians as the intended users.

Some of these expanded uses could fall within the bounds of the FDA’s initial clearance and thus not trigger a need for a new marketing submission, the agency said. But seeking to shift this hypothetical product to “patient-facing” use would require a new marketing submission to the FDA, the agency said.

In this scenario, a company would expect people to follow up with a dermatologist after receiving a report suggesting cancer. Thus, this kind of a change could expose patients to “many new, unconsidered risks,” the FDA said.
 

Reality check?

The state of current efforts to develop consumer apps for checking for skin cancer seems to be summarized well on the website for the MoleMapper. The app was developed by researchers at OHSU to help people track how their moles change over time.

“Mole Mapper is NOT designed to provide medical advice, professional diagnosis, opinion, or treatment. Currently, there is not enough data to develop an app that can diagnose melanoma, but if enough data is collected through Mole Mapper and shared with researchers, it may be possible in the future,” the app’s website says.

OHSU released MoleMapper as an iPhone app in 2015. The aim of this project was to help people track the moles on their skin while also fostering an experiment in “citizen science,” OHSU’s Dr. Leachman told this news organization.

OHSU researchers hoped that the digital images taken by members of the public on cell phones could one day be used to develop diagnostic algorithms for melanoma.

But around 2017, the MoleMapper team realized that they would not be able to create a diagnostic app at this time, Dr. Leachman explained. They could not collect enough data of adequate quality.

And by 2021, it was clear that they could not even develop a successful app to triage patients to assess who needs to be seen quickly. The amount of data required was, at this point, beyond what the team could collect, Dr. Leachman said in an interview.

That was a disappointment because the team had successfully completed the difficult task of creating a confidential pathway for collecting these images via both iPhones and smartphones run on Android.

“We thought if we built it, people would come, but that’s not what happened,” Dr. Leachman said. Many patients didn’t want their images used for research or would fail to follow up with details of biopsy reports. Sometimes images were not captured well enough to be of use.

“You need at least hundreds of thousands, if not millions, of data points that have been verified with pathologies, and nobody was giving us back that data. That was the reality,” Dr. Leachman said.

There were valuable lessons in that setback. The OHSU team now has a better grasp of the challenges of trying to build a data-collection system that could prove helpful in assessing skin lesions.

“If you don’t build it, you don’t know” what can go wrong, she said.

Dr. Leachman said other scientists who have worked on similar projects to build skin-analyzing apps have probably encountered the same difficulties, although they may not reveal these issues. “I think that a lot of people build these things and then they try to make it into something that it’s not,” she said.

In addition to the challenges with gathering images, dermatologists frequently need to rely on touch and other clues from in-person visits when diagnosing a suspicious lesion. “There’s something about seeing and feeling the skin in person that can’t be captured completely with an image,” Dr. Leachman said.
 

Public demand

Still, regulators must face the strong and immediate interest consumers have in using AI to check on moles and skin conditions, despite continuing questions about how well this approach might work.

In June, Google announced in a blog post that its Google Lens tool can help people research skin conditions.

“Just take a picture or upload a photo through Lens, and you’ll find visual matches to inform your search,” Google said in a blog post. “This feature also works if you’re not sure how to describe something else on your body, like a bump on your lip, a line on your nails or hair loss on your head. This feature is currently available in the U.S.”

Google also continues work on DermAssist, an app that’s intended to help people get personalized information about skin concerns using three photos. It is not currently publicly available, a Google spokesperson told this news organization.

Several skin-analyzing apps are already available in the Apple and Google Play stores. The British Association of Dermatologists last year issued a press release warning consumers that these apps may not be safe or effective and thus may put patients at risk for misdiagnosis.

“Unfortunately, AI-based apps which do not appear to meet regulatory requirements crop up more often than we would like,” the association said. “Additionally, the evidence to support the use of AI to diagnose skin conditions is weak which means that when it is used, it may not be safe or effective and it is possible that AI is putting patients at risk of misdiagnosis.”

Delicate and difficult balancing act

At this time, regulators, entrepreneurs, and the medical community face a delicate balancing act in considering how best to deploy AI in skin care, Dr. Ko said in an interview. (In addition to being one of the authors on the widely cited 2017 Nature paper mentioned above, Dr. Ko served until March as the initial chair of the American Academy of Dermatology’s Augmented Intelligence Committee.)

There are many solid reasons why there hasn’t been speedy progress to deploy AI in dermatology, as many envisioned a few years ago, Dr. Ko said.

Some of those reasons are specific to dermatology; this field doesn’t have a ready set of robust data from which to build AI-driven tools. In this aspect, dermatology is decades behind specialties like radiology, pathology, and ophthalmology, where clinicians have long been accumulating and storing images and other data in more standardized ways, Dr. Ko said.

“If you went to most dermatology practices and said, ‘Hey, let me learn from the data accumulated over the course of your 30-year practice to help us develop new tools,’” there may not be a whole lot there,” Dr. Ko said.

Beyond the start-up hurdles is the larger concern Dr. Ko shares with other dermatologists who work in this field, such as Dr. Daneshjou and Dr. Leachman. What would clinicians without much dermatology training and patients do with the readings from AI-driven tools and apps?

There would need to be significant research to show that such products actually help get people treated for skin diseases, including skin cancer.

Dr. Ko praised Google for being open about the stumbles with its efforts to use its AI tool for identifying diabetic retinopathy in a test in Thailand. Real-world hitches included poor Internet connections and poor image quality.

Developing reliable systems, processes, and workflows will be paramount for eventual widespread use of AI-driven tools, Dr. Ko said.

“It’s all those hidden things that are not sexy,” as are announcements about algorithms working about as well as clinicians in diagnosis, Dr. Ko said. “They don’t get the media attention, but they’re going to be make or break for AI, not just in our field but [for] AI in general.”

But he added that there also needs to be a recognition that AI-driven tools and products, even if somewhat imperfect, can help people get access to care.

In many cases, shortages of specialists prevent people from getting screened for treatable conditions such as skin cancer and retinopathy. The challenge is setting an appropriate standard to make sure that AI-driven products would help most patients in practice, without raising it so high that no such products emerge.

“There’s a risk of holding too high of a bar,” Dr. Ko said. “There is harm in not moving forward as well.”

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

An influential Nature paper predicted in 2017 that advances in artificial intelligence (AI) could unleash remarkable changes in dermatology, such as using phones to help detect skin cancer earlier.

Given that about 6.3 billion smartphones would soon be in use, this AI approach could provide a gateway for “low-cost universal access to vital diagnostic care,” wrote Justin M. Ko, MD, MBA, a dermatologist, and colleagues from Stanford (Calif.) University that included other dermatologists and engineers.

Dr. Ko and his coauthors described how they trained a computer system to identify both benign and cancerous skin lesions. They used an approach known as a convolutional neural network, often deployed for projects seeking to train computers to “see” through image analysis. They said that their test of this system found it to be on par with the performance of 21 board-certified dermatologists.

“This fast, scalable method is deployable on mobile devices and holds the potential for substantial clinical impact, including broadening the scope of primary care practice and augmenting clinical decision-making for dermatology specialists,” they wrote in their paper.

More than 6 years later, there are signs that companies are making progress toward moving skin checks using this technology into U.S. primary care settings – but only with devices that employ special tools.

It may prove tougher for companies to eventually secure the sign-off of the U.S. Food and Drug Administration for mobile apps intended to let consumers handle this task with smartphones.

Such tools would need to be proven highly accurate before release, because too many false positives mean that people would be needlessly exposed to biopsies, said Sancy A. Leachman, MD, PhD, director of the melanoma research program and chair of the department of dermatology at Oregon Health & Science University, Portland.

And false-negative readings would allow melanoma to advance and even be fatal, Dr. Leachman told this news organization.

Roxana Daneshjou, MD, PhD, a dermatologist at Stanford who has studied the promise and the pitfalls of AI in medicine, said that developers of a consumer skin-check app would need to know how people would react to their readings. That includes a good sense of how often they would appropriately seek medical care for a concerning reading. (She was not an author of the previously cited Nature paper but has published widely on AI.)

Christopher Smith

“The direct-to-consumer diagnostic space makes me nervous,” Dr. Daneshjou said in an interview. “In order to do it, you really need to have good studies in consumer populations prior to release. You need to show how effective it is with follow up.”
 

FDA shows interest – and reservations

As of July, the FDA had not yet given its okay for marketing of any consumer apps intended to help people detect signs of skin cancer, an agency spokesperson told this news organization.

To date, the agency has only cleared two AI-based products for this task, both meant to be used by dermatologists. And only one of these two products, Scibase’s Nevisense, remains in use in the United States. The other, MelaFind, has been discontinued. In 2017, Strata Skin Sciences said that the product did not win “a significant enough level of acceptance by dermatologists to justify the continued investment” in it. And the company said it notified the 90 owners of MelaFind devices in the United States that it would no longer support the device.

But another company, DermaSensor, said in a 2021 press release that it expects its AI-powered tool, also named DermaSensor, to be the “first ever FDA cleared or approved skin cancer detection device for primary care providers.”

The Miami-based firm said that the FDA had granted its product a “breakthrough” device designation. A breakthrough designation means that agency staff will offer extra help and guidance to companies in developing a product, because of its expected benefit for patients.

In a 2020 press release, 3Derm Systems, now owned by Digital Diagnostics, made a similar announcement about winning FDA breakthrough designation for an AI-powered tool intended to allow skin checks in primary care settings.

(The FDA generally does not comment on its reviews of experimental drugs and devices, but companies can do so. Several other companies have announced FDA breakthrough designations for AI-driven products intended to check for skin lesions, but these might be used in settings other than primary care.)

Both DermaSensor and Digital Diagnostics have chairs with notable track records for winning FDA approvals of other devices. DermaSensor’s Maurice Ferre, MD, also is the chairman of Insightec, which in 2016 won the first FDA approval for a device with a breakthrough designation device that uses ultrasound to treat tremors.

In 2018, the FDA allowed Digital Diagnostics, then called IDx, to introduce in the United States the first medical device using AI in primary care offices to check for signs of diabetic retinopathy. This product also had an FDA breakthrough designation. The executive chairman and founder of Digital Diagnostics is Michael Abramoff, MD, PhD, professor of engineering and ophthalmology at the University of Iowa, Iowa City. Dr. Abramoff and the team behind the AI tool for retinopathy, now called the LumineticsCore system, also scored a notable win with Medicare, which agreed to cover use of the product through a dedicated CPT code.
 

FDA draft guidance

The FDA has acknowledged the interest in broadening access to skin checks via AI.

This was a topic of discussion at a 2-day advisory committee meeting the FDA held last year. In April 2023, the FDA outlined some of its expectations for future regulation of skin-analyzing tools as part of a wide-ranging draft guidance document intended to aid companies in their efforts to develop products using a form of AI known as machine learning.

In the document, the FDA described how it might approach applications for “hypothetical” devices using this kind of AI, such as a special tool to help primary care clinicians identify lesions in need of further investigation. Such a product would use a specific camera for gathering data for its initial clearance, in the FDA’s hypothetical scenario.

The FDA staff offered technical suggestions about what the developer of this hypothetical device would have to do to extend its use to smartphones and tablets while keeping clinicians as the intended users.

Some of these expanded uses could fall within the bounds of the FDA’s initial clearance and thus not trigger a need for a new marketing submission, the agency said. But seeking to shift this hypothetical product to “patient-facing” use would require a new marketing submission to the FDA, the agency said.

In this scenario, a company would expect people to follow up with a dermatologist after receiving a report suggesting cancer. Thus, this kind of a change could expose patients to “many new, unconsidered risks,” the FDA said.
 

Reality check?

The state of current efforts to develop consumer apps for checking for skin cancer seems to be summarized well on the website for the MoleMapper. The app was developed by researchers at OHSU to help people track how their moles change over time.

“Mole Mapper is NOT designed to provide medical advice, professional diagnosis, opinion, or treatment. Currently, there is not enough data to develop an app that can diagnose melanoma, but if enough data is collected through Mole Mapper and shared with researchers, it may be possible in the future,” the app’s website says.

OHSU released MoleMapper as an iPhone app in 2015. The aim of this project was to help people track the moles on their skin while also fostering an experiment in “citizen science,” OHSU’s Dr. Leachman told this news organization.

OHSU researchers hoped that the digital images taken by members of the public on cell phones could one day be used to develop diagnostic algorithms for melanoma.

But around 2017, the MoleMapper team realized that they would not be able to create a diagnostic app at this time, Dr. Leachman explained. They could not collect enough data of adequate quality.

And by 2021, it was clear that they could not even develop a successful app to triage patients to assess who needs to be seen quickly. The amount of data required was, at this point, beyond what the team could collect, Dr. Leachman said in an interview.

That was a disappointment because the team had successfully completed the difficult task of creating a confidential pathway for collecting these images via both iPhones and smartphones run on Android.

“We thought if we built it, people would come, but that’s not what happened,” Dr. Leachman said. Many patients didn’t want their images used for research or would fail to follow up with details of biopsy reports. Sometimes images were not captured well enough to be of use.

“You need at least hundreds of thousands, if not millions, of data points that have been verified with pathologies, and nobody was giving us back that data. That was the reality,” Dr. Leachman said.

There were valuable lessons in that setback. The OHSU team now has a better grasp of the challenges of trying to build a data-collection system that could prove helpful in assessing skin lesions.

“If you don’t build it, you don’t know” what can go wrong, she said.

Dr. Leachman said other scientists who have worked on similar projects to build skin-analyzing apps have probably encountered the same difficulties, although they may not reveal these issues. “I think that a lot of people build these things and then they try to make it into something that it’s not,” she said.

In addition to the challenges with gathering images, dermatologists frequently need to rely on touch and other clues from in-person visits when diagnosing a suspicious lesion. “There’s something about seeing and feeling the skin in person that can’t be captured completely with an image,” Dr. Leachman said.
 

Public demand

Still, regulators must face the strong and immediate interest consumers have in using AI to check on moles and skin conditions, despite continuing questions about how well this approach might work.

In June, Google announced in a blog post that its Google Lens tool can help people research skin conditions.

“Just take a picture or upload a photo through Lens, and you’ll find visual matches to inform your search,” Google said in a blog post. “This feature also works if you’re not sure how to describe something else on your body, like a bump on your lip, a line on your nails or hair loss on your head. This feature is currently available in the U.S.”

Google also continues work on DermAssist, an app that’s intended to help people get personalized information about skin concerns using three photos. It is not currently publicly available, a Google spokesperson told this news organization.

Several skin-analyzing apps are already available in the Apple and Google Play stores. The British Association of Dermatologists last year issued a press release warning consumers that these apps may not be safe or effective and thus may put patients at risk for misdiagnosis.

“Unfortunately, AI-based apps which do not appear to meet regulatory requirements crop up more often than we would like,” the association said. “Additionally, the evidence to support the use of AI to diagnose skin conditions is weak which means that when it is used, it may not be safe or effective and it is possible that AI is putting patients at risk of misdiagnosis.”

Delicate and difficult balancing act

At this time, regulators, entrepreneurs, and the medical community face a delicate balancing act in considering how best to deploy AI in skin care, Dr. Ko said in an interview. (In addition to being one of the authors on the widely cited 2017 Nature paper mentioned above, Dr. Ko served until March as the initial chair of the American Academy of Dermatology’s Augmented Intelligence Committee.)

There are many solid reasons why there hasn’t been speedy progress to deploy AI in dermatology, as many envisioned a few years ago, Dr. Ko said.

Some of those reasons are specific to dermatology; this field doesn’t have a ready set of robust data from which to build AI-driven tools. In this aspect, dermatology is decades behind specialties like radiology, pathology, and ophthalmology, where clinicians have long been accumulating and storing images and other data in more standardized ways, Dr. Ko said.

“If you went to most dermatology practices and said, ‘Hey, let me learn from the data accumulated over the course of your 30-year practice to help us develop new tools,’” there may not be a whole lot there,” Dr. Ko said.

Beyond the start-up hurdles is the larger concern Dr. Ko shares with other dermatologists who work in this field, such as Dr. Daneshjou and Dr. Leachman. What would clinicians without much dermatology training and patients do with the readings from AI-driven tools and apps?

There would need to be significant research to show that such products actually help get people treated for skin diseases, including skin cancer.

Dr. Ko praised Google for being open about the stumbles with its efforts to use its AI tool for identifying diabetic retinopathy in a test in Thailand. Real-world hitches included poor Internet connections and poor image quality.

Developing reliable systems, processes, and workflows will be paramount for eventual widespread use of AI-driven tools, Dr. Ko said.

“It’s all those hidden things that are not sexy,” as are announcements about algorithms working about as well as clinicians in diagnosis, Dr. Ko said. “They don’t get the media attention, but they’re going to be make or break for AI, not just in our field but [for] AI in general.”

But he added that there also needs to be a recognition that AI-driven tools and products, even if somewhat imperfect, can help people get access to care.

In many cases, shortages of specialists prevent people from getting screened for treatable conditions such as skin cancer and retinopathy. The challenge is setting an appropriate standard to make sure that AI-driven products would help most patients in practice, without raising it so high that no such products emerge.

“There’s a risk of holding too high of a bar,” Dr. Ko said. “There is harm in not moving forward as well.”

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

An influential Nature paper predicted in 2017 that advances in artificial intelligence (AI) could unleash remarkable changes in dermatology, such as using phones to help detect skin cancer earlier.

Given that about 6.3 billion smartphones would soon be in use, this AI approach could provide a gateway for “low-cost universal access to vital diagnostic care,” wrote Justin M. Ko, MD, MBA, a dermatologist, and colleagues from Stanford (Calif.) University that included other dermatologists and engineers.

Dr. Ko and his coauthors described how they trained a computer system to identify both benign and cancerous skin lesions. They used an approach known as a convolutional neural network, often deployed for projects seeking to train computers to “see” through image analysis. They said that their test of this system found it to be on par with the performance of 21 board-certified dermatologists.

“This fast, scalable method is deployable on mobile devices and holds the potential for substantial clinical impact, including broadening the scope of primary care practice and augmenting clinical decision-making for dermatology specialists,” they wrote in their paper.

More than 6 years later, there are signs that companies are making progress toward moving skin checks using this technology into U.S. primary care settings – but only with devices that employ special tools.

It may prove tougher for companies to eventually secure the sign-off of the U.S. Food and Drug Administration for mobile apps intended to let consumers handle this task with smartphones.

Such tools would need to be proven highly accurate before release, because too many false positives mean that people would be needlessly exposed to biopsies, said Sancy A. Leachman, MD, PhD, director of the melanoma research program and chair of the department of dermatology at Oregon Health & Science University, Portland.

And false-negative readings would allow melanoma to advance and even be fatal, Dr. Leachman told this news organization.

Roxana Daneshjou, MD, PhD, a dermatologist at Stanford who has studied the promise and the pitfalls of AI in medicine, said that developers of a consumer skin-check app would need to know how people would react to their readings. That includes a good sense of how often they would appropriately seek medical care for a concerning reading. (She was not an author of the previously cited Nature paper but has published widely on AI.)

Christopher Smith

“The direct-to-consumer diagnostic space makes me nervous,” Dr. Daneshjou said in an interview. “In order to do it, you really need to have good studies in consumer populations prior to release. You need to show how effective it is with follow up.”
 

FDA shows interest – and reservations

As of July, the FDA had not yet given its okay for marketing of any consumer apps intended to help people detect signs of skin cancer, an agency spokesperson told this news organization.

To date, the agency has only cleared two AI-based products for this task, both meant to be used by dermatologists. And only one of these two products, Scibase’s Nevisense, remains in use in the United States. The other, MelaFind, has been discontinued. In 2017, Strata Skin Sciences said that the product did not win “a significant enough level of acceptance by dermatologists to justify the continued investment” in it. And the company said it notified the 90 owners of MelaFind devices in the United States that it would no longer support the device.

But another company, DermaSensor, said in a 2021 press release that it expects its AI-powered tool, also named DermaSensor, to be the “first ever FDA cleared or approved skin cancer detection device for primary care providers.”

The Miami-based firm said that the FDA had granted its product a “breakthrough” device designation. A breakthrough designation means that agency staff will offer extra help and guidance to companies in developing a product, because of its expected benefit for patients.

In a 2020 press release, 3Derm Systems, now owned by Digital Diagnostics, made a similar announcement about winning FDA breakthrough designation for an AI-powered tool intended to allow skin checks in primary care settings.

(The FDA generally does not comment on its reviews of experimental drugs and devices, but companies can do so. Several other companies have announced FDA breakthrough designations for AI-driven products intended to check for skin lesions, but these might be used in settings other than primary care.)

Both DermaSensor and Digital Diagnostics have chairs with notable track records for winning FDA approvals of other devices. DermaSensor’s Maurice Ferre, MD, also is the chairman of Insightec, which in 2016 won the first FDA approval for a device with a breakthrough designation device that uses ultrasound to treat tremors.

In 2018, the FDA allowed Digital Diagnostics, then called IDx, to introduce in the United States the first medical device using AI in primary care offices to check for signs of diabetic retinopathy. This product also had an FDA breakthrough designation. The executive chairman and founder of Digital Diagnostics is Michael Abramoff, MD, PhD, professor of engineering and ophthalmology at the University of Iowa, Iowa City. Dr. Abramoff and the team behind the AI tool for retinopathy, now called the LumineticsCore system, also scored a notable win with Medicare, which agreed to cover use of the product through a dedicated CPT code.
 

FDA draft guidance

The FDA has acknowledged the interest in broadening access to skin checks via AI.

This was a topic of discussion at a 2-day advisory committee meeting the FDA held last year. In April 2023, the FDA outlined some of its expectations for future regulation of skin-analyzing tools as part of a wide-ranging draft guidance document intended to aid companies in their efforts to develop products using a form of AI known as machine learning.

In the document, the FDA described how it might approach applications for “hypothetical” devices using this kind of AI, such as a special tool to help primary care clinicians identify lesions in need of further investigation. Such a product would use a specific camera for gathering data for its initial clearance, in the FDA’s hypothetical scenario.

The FDA staff offered technical suggestions about what the developer of this hypothetical device would have to do to extend its use to smartphones and tablets while keeping clinicians as the intended users.

Some of these expanded uses could fall within the bounds of the FDA’s initial clearance and thus not trigger a need for a new marketing submission, the agency said. But seeking to shift this hypothetical product to “patient-facing” use would require a new marketing submission to the FDA, the agency said.

In this scenario, a company would expect people to follow up with a dermatologist after receiving a report suggesting cancer. Thus, this kind of a change could expose patients to “many new, unconsidered risks,” the FDA said.
 

Reality check?

The state of current efforts to develop consumer apps for checking for skin cancer seems to be summarized well on the website for the MoleMapper. The app was developed by researchers at OHSU to help people track how their moles change over time.

“Mole Mapper is NOT designed to provide medical advice, professional diagnosis, opinion, or treatment. Currently, there is not enough data to develop an app that can diagnose melanoma, but if enough data is collected through Mole Mapper and shared with researchers, it may be possible in the future,” the app’s website says.

OHSU released MoleMapper as an iPhone app in 2015. The aim of this project was to help people track the moles on their skin while also fostering an experiment in “citizen science,” OHSU’s Dr. Leachman told this news organization.

OHSU researchers hoped that the digital images taken by members of the public on cell phones could one day be used to develop diagnostic algorithms for melanoma.

But around 2017, the MoleMapper team realized that they would not be able to create a diagnostic app at this time, Dr. Leachman explained. They could not collect enough data of adequate quality.

And by 2021, it was clear that they could not even develop a successful app to triage patients to assess who needs to be seen quickly. The amount of data required was, at this point, beyond what the team could collect, Dr. Leachman said in an interview.

That was a disappointment because the team had successfully completed the difficult task of creating a confidential pathway for collecting these images via both iPhones and smartphones run on Android.

“We thought if we built it, people would come, but that’s not what happened,” Dr. Leachman said. Many patients didn’t want their images used for research or would fail to follow up with details of biopsy reports. Sometimes images were not captured well enough to be of use.

“You need at least hundreds of thousands, if not millions, of data points that have been verified with pathologies, and nobody was giving us back that data. That was the reality,” Dr. Leachman said.

There were valuable lessons in that setback. The OHSU team now has a better grasp of the challenges of trying to build a data-collection system that could prove helpful in assessing skin lesions.

“If you don’t build it, you don’t know” what can go wrong, she said.

Dr. Leachman said other scientists who have worked on similar projects to build skin-analyzing apps have probably encountered the same difficulties, although they may not reveal these issues. “I think that a lot of people build these things and then they try to make it into something that it’s not,” she said.

In addition to the challenges with gathering images, dermatologists frequently need to rely on touch and other clues from in-person visits when diagnosing a suspicious lesion. “There’s something about seeing and feeling the skin in person that can’t be captured completely with an image,” Dr. Leachman said.
 

Public demand

Still, regulators must face the strong and immediate interest consumers have in using AI to check on moles and skin conditions, despite continuing questions about how well this approach might work.

In June, Google announced in a blog post that its Google Lens tool can help people research skin conditions.

“Just take a picture or upload a photo through Lens, and you’ll find visual matches to inform your search,” Google said in a blog post. “This feature also works if you’re not sure how to describe something else on your body, like a bump on your lip, a line on your nails or hair loss on your head. This feature is currently available in the U.S.”

Google also continues work on DermAssist, an app that’s intended to help people get personalized information about skin concerns using three photos. It is not currently publicly available, a Google spokesperson told this news organization.

Several skin-analyzing apps are already available in the Apple and Google Play stores. The British Association of Dermatologists last year issued a press release warning consumers that these apps may not be safe or effective and thus may put patients at risk for misdiagnosis.

“Unfortunately, AI-based apps which do not appear to meet regulatory requirements crop up more often than we would like,” the association said. “Additionally, the evidence to support the use of AI to diagnose skin conditions is weak which means that when it is used, it may not be safe or effective and it is possible that AI is putting patients at risk of misdiagnosis.”

Delicate and difficult balancing act

At this time, regulators, entrepreneurs, and the medical community face a delicate balancing act in considering how best to deploy AI in skin care, Dr. Ko said in an interview. (In addition to being one of the authors on the widely cited 2017 Nature paper mentioned above, Dr. Ko served until March as the initial chair of the American Academy of Dermatology’s Augmented Intelligence Committee.)

There are many solid reasons why there hasn’t been speedy progress to deploy AI in dermatology, as many envisioned a few years ago, Dr. Ko said.

Some of those reasons are specific to dermatology; this field doesn’t have a ready set of robust data from which to build AI-driven tools. In this aspect, dermatology is decades behind specialties like radiology, pathology, and ophthalmology, where clinicians have long been accumulating and storing images and other data in more standardized ways, Dr. Ko said.

“If you went to most dermatology practices and said, ‘Hey, let me learn from the data accumulated over the course of your 30-year practice to help us develop new tools,’” there may not be a whole lot there,” Dr. Ko said.

Beyond the start-up hurdles is the larger concern Dr. Ko shares with other dermatologists who work in this field, such as Dr. Daneshjou and Dr. Leachman. What would clinicians without much dermatology training and patients do with the readings from AI-driven tools and apps?

There would need to be significant research to show that such products actually help get people treated for skin diseases, including skin cancer.

Dr. Ko praised Google for being open about the stumbles with its efforts to use its AI tool for identifying diabetic retinopathy in a test in Thailand. Real-world hitches included poor Internet connections and poor image quality.

Developing reliable systems, processes, and workflows will be paramount for eventual widespread use of AI-driven tools, Dr. Ko said.

“It’s all those hidden things that are not sexy,” as are announcements about algorithms working about as well as clinicians in diagnosis, Dr. Ko said. “They don’t get the media attention, but they’re going to be make or break for AI, not just in our field but [for] AI in general.”

But he added that there also needs to be a recognition that AI-driven tools and products, even if somewhat imperfect, can help people get access to care.

In many cases, shortages of specialists prevent people from getting screened for treatable conditions such as skin cancer and retinopathy. The challenge is setting an appropriate standard to make sure that AI-driven products would help most patients in practice, without raising it so high that no such products emerge.

“There’s a risk of holding too high of a bar,” Dr. Ko said. “There is harm in not moving forward as well.”

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

A multicenter, international phase 2 trial known as EDELIFE is underway to investigate the safety and efficacy of an in utero treatment for developing males with X-linked hypohidrotic ectodermal dysplasia (XLHED).

This condition is caused by mutations in the gene coding for ectodysplasin A (EDA), a protein that signals the epithelial-mesenchymal transition during embryogenesis. EDA loss or dysfunction precludes binding to its endogenous EDA1 receptor (EDAR), and downstream development of teeth, hair, nails, and skin adnexae, most notably eccrine glands.

shironosov/Getty Images

The treatment, ER004, is a first-in-class signaling protein EDA replacement molecule now under investigation by the EspeRare Foundation, with support from the Pierre Fabre Foundation. The pioneering clinical trial is evaluating the delivery of ER004 protein replacement in utero to affected fetuses, allowing antenatal binding to the EDAR. According to the EDELIFE web site, when ER004 is administered to XLHED-affected males in utero, it “should act as a replacement for the missing EDA and trigger the process that leads to the normal development of a baby’s skin, teeth, hair, and sweat glands, leading to better formation of these structures.”

The protein is delivered into the amniotic fluid via a needle and syringe under ultrasound guidance. In a report on this treatment used in a pair of affected twins and a third XLHED-affected male published in 2018, the authors reported that the three babies were able to sweat normally after birth, “and XLHED-related illness had not developed by 14-22 months of age.”

The goal of the prospective, open-label, genotype match–controlled EDELIFE trial is to confirm the efficacy and safety results for ER004 in a larger group of boys, and to determine if it can lead to robust, and long-lasting improvement in XLHED-associated defects.

In the United States, the first pregnant woman to join the study received the treatment in February 2023 at Washington University in St. Louis. Other clinical sites are located in France, Germany, Italy, Spain, and the United Kingdom. Led by principal investigator Holm Schneider, MD, of the University Erlanger-Nurnberg (Germany), researchers are seeking to enroll mothers aged 18 years and older who are genetically confirmed carriers of the XLHED mutation and pregnant with a boy or considering pregnancy. The control group will include XLHED-affected males, 6 months to 60 years old, who are blood relatives of the pregnant woman participating in the study.

Clinicians treating affected families or potentially eligible subjects are encouraged to contact the trial investigators at this link.

A multicenter, international phase 2 trial known as EDELIFE is underway to investigate the safety and efficacy of an in utero treatment for developing males with X-linked hypohidrotic ectodermal dysplasia (XLHED).

This condition is caused by mutations in the gene coding for ectodysplasin A (EDA), a protein that signals the epithelial-mesenchymal transition during embryogenesis. EDA loss or dysfunction precludes binding to its endogenous EDA1 receptor (EDAR), and downstream development of teeth, hair, nails, and skin adnexae, most notably eccrine glands.

shironosov/Getty Images

The treatment, ER004, is a first-in-class signaling protein EDA replacement molecule now under investigation by the EspeRare Foundation, with support from the Pierre Fabre Foundation. The pioneering clinical trial is evaluating the delivery of ER004 protein replacement in utero to affected fetuses, allowing antenatal binding to the EDAR. According to the EDELIFE web site, when ER004 is administered to XLHED-affected males in utero, it “should act as a replacement for the missing EDA and trigger the process that leads to the normal development of a baby’s skin, teeth, hair, and sweat glands, leading to better formation of these structures.”

The protein is delivered into the amniotic fluid via a needle and syringe under ultrasound guidance. In a report on this treatment used in a pair of affected twins and a third XLHED-affected male published in 2018, the authors reported that the three babies were able to sweat normally after birth, “and XLHED-related illness had not developed by 14-22 months of age.”

The goal of the prospective, open-label, genotype match–controlled EDELIFE trial is to confirm the efficacy and safety results for ER004 in a larger group of boys, and to determine if it can lead to robust, and long-lasting improvement in XLHED-associated defects.

In the United States, the first pregnant woman to join the study received the treatment in February 2023 at Washington University in St. Louis. Other clinical sites are located in France, Germany, Italy, Spain, and the United Kingdom. Led by principal investigator Holm Schneider, MD, of the University Erlanger-Nurnberg (Germany), researchers are seeking to enroll mothers aged 18 years and older who are genetically confirmed carriers of the XLHED mutation and pregnant with a boy or considering pregnancy. The control group will include XLHED-affected males, 6 months to 60 years old, who are blood relatives of the pregnant woman participating in the study.

Clinicians treating affected families or potentially eligible subjects are encouraged to contact the trial investigators at this link.

A multicenter, international phase 2 trial known as EDELIFE is underway to investigate the safety and efficacy of an in utero treatment for developing males with X-linked hypohidrotic ectodermal dysplasia (XLHED).

This condition is caused by mutations in the gene coding for ectodysplasin A (EDA), a protein that signals the epithelial-mesenchymal transition during embryogenesis. EDA loss or dysfunction precludes binding to its endogenous EDA1 receptor (EDAR), and downstream development of teeth, hair, nails, and skin adnexae, most notably eccrine glands.

shironosov/Getty Images

The treatment, ER004, is a first-in-class signaling protein EDA replacement molecule now under investigation by the EspeRare Foundation, with support from the Pierre Fabre Foundation. The pioneering clinical trial is evaluating the delivery of ER004 protein replacement in utero to affected fetuses, allowing antenatal binding to the EDAR. According to the EDELIFE web site, when ER004 is administered to XLHED-affected males in utero, it “should act as a replacement for the missing EDA and trigger the process that leads to the normal development of a baby’s skin, teeth, hair, and sweat glands, leading to better formation of these structures.”

The protein is delivered into the amniotic fluid via a needle and syringe under ultrasound guidance. In a report on this treatment used in a pair of affected twins and a third XLHED-affected male published in 2018, the authors reported that the three babies were able to sweat normally after birth, “and XLHED-related illness had not developed by 14-22 months of age.”

The goal of the prospective, open-label, genotype match–controlled EDELIFE trial is to confirm the efficacy and safety results for ER004 in a larger group of boys, and to determine if it can lead to robust, and long-lasting improvement in XLHED-associated defects.

In the United States, the first pregnant woman to join the study received the treatment in February 2023 at Washington University in St. Louis. Other clinical sites are located in France, Germany, Italy, Spain, and the United Kingdom. Led by principal investigator Holm Schneider, MD, of the University Erlanger-Nurnberg (Germany), researchers are seeking to enroll mothers aged 18 years and older who are genetically confirmed carriers of the XLHED mutation and pregnant with a boy or considering pregnancy. The control group will include XLHED-affected males, 6 months to 60 years old, who are blood relatives of the pregnant woman participating in the study.

Clinicians treating affected families or potentially eligible subjects are encouraged to contact the trial investigators at this link.

Female sex, hyperlipidemia, Medicaid insurance, earlier year of biologic initiation, shorter duration of psoriasis, and prior nonbiologic systemic therapy use were associated with multiple biologic failure in patients with psoriasis, results from a prospective cohort demonstrated.

“Prior cross-sectional and single-center studies have primarily analyzed therapeutic failure of a single biologic or biologics within one class,” researchers led by Wilson Liao, MD, professor and vice chair of research in the department of dermatology at the University of California, San Francisco, wrote in the study, published in the Journal of the American Academy of Dermatology. “However, failure of multiple biologics targeting different signaling pathways is common over the course of treatment. These ‘multiple biologic failure’ patients are not well-characterized, and the patterns of biologics attempted and sociodemographic or clinical features that may predict difficult treatment are incompletely studied.”

To bridge this gap, the researchers conducted a prospective cohort study from the CorEvitas Psoriasis Registry, which collected data from dermatologist-diagnosed patients with psoriasis who started or switched to a Food and Drug Administration (FDA)–approved systemic therapy for psoriasis during routine dermatology visits from April 15, 2015, to May 10, 2022. This period included data from 17,196 patients across 259 private and 209 academic sites from 580 physicians in the United States and Canada.

From this registry, Dr. Liao and colleagues identified 1,039 patients with 24 months or more of follow-up data, a confirmed index biologic start date, and valid baseline assessment data, and categorized them into three cohorts:

• 490 (47.2%) with good response (GR), defined as patients with 24 months or more of continued index biologic use by the last registry visit.
• 65 (6.3%) with multiple biologic failure (MBF), defined as patients administered two or more biologic agents of different mechanistic classes who discontinued these biologics because of physician-reported “inadequate initial response,” “failure to maintain initial response,” or “active disease” despite 90 or more days of use per biologic.
• 484 (46.6%) categorized as “other,” defined as patients failed by one biologic or who discontinued treatment for nonmedical reasons.

The researchers used multivariable logistic regression to identify sociodemographic, clinical, and patient-reported outcomes that differed between the MBF and GR groups. The mean age of the patients in the study was 49.1 years, 44.2% were female, 77.9% were White, 9.7% were Hispanic, and the mean duration of psoriasis was 11.5 years.

On multivariable logistic regression, factors associated with MBF, compared with those with GR, included female at birth (odds ratio [OR] = 2.29; confidence interval [CI], 1.11-4.72), history of hyperlipidemia (OR = 3.14; CI, 1.35-7.30), Medicaid insurance (OR = 4.53; CI, 1.40-14.60), prior nonbiologic systemic therapy (OR = 2.47; CI, 1.16-5.25), higher psoriasis duration (OR = 0.60 per standard deviation [SD]; CI, 0.38-0.94), and later index biologic initiation (OR = 0.37 per year; CI, 0.27-0.52). Sensitivity analysis revealed that the duration of prior nonbiologic systemic therapy use was not associated with MBF (OR = 0.99; CI, 0.94-1.02; P = 0.56).

“Interestingly, health-related behaviors (e.g., smoking, alcohol use) and location/extent of psoriasis were not important differentiators between MBF and GR,” the authors noted. “We might suspect these features to correlate with MBF, as numerous observational studies found associations between health-related behaviors or psoriasis severity and presence at difficult-to-treat locations, which often relates to biologic use.”

They acknowledged certain limitations of their study, including underrepresentation of ethnoracial minorities and male sex at birth relative to reported psoriasis epidemiology, “possibly reflecting participation bias and reduced access to specialty care, given that patients were enrolled into the registry by dermatologists,” they wrote. “Patient adherence to prescribed biologic regimens between registry visits was not evaluated.”

Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that despite the rapid expansion in biologic therapies for psoriasis, “analysis of real-world use patterns and patient characteristics has been limited – particularly for those who have failed multiple treatments. These findings suggest that there indeed may be some key differences between patients who have had to cycle through multiple biologics versus those who have had a sustained satisfactory response on a single therapy, such as disease duration and previous nonbiologic treatments.”

Dr. Chovatiya

Female sex, hyperlipidemia, Medicaid insurance, earlier year of biologic initiation, shorter duration of psoriasis, and prior nonbiologic systemic therapy use were associated with multiple biologic failure in patients with psoriasis, results from a prospective cohort demonstrated.

“Prior cross-sectional and single-center studies have primarily analyzed therapeutic failure of a single biologic or biologics within one class,” researchers led by Wilson Liao, MD, professor and vice chair of research in the department of dermatology at the University of California, San Francisco, wrote in the study, published in the Journal of the American Academy of Dermatology. “However, failure of multiple biologics targeting different signaling pathways is common over the course of treatment. These ‘multiple biologic failure’ patients are not well-characterized, and the patterns of biologics attempted and sociodemographic or clinical features that may predict difficult treatment are incompletely studied.”

To bridge this gap, the researchers conducted a prospective cohort study from the CorEvitas Psoriasis Registry, which collected data from dermatologist-diagnosed patients with psoriasis who started or switched to a Food and Drug Administration (FDA)–approved systemic therapy for psoriasis during routine dermatology visits from April 15, 2015, to May 10, 2022. This period included data from 17,196 patients across 259 private and 209 academic sites from 580 physicians in the United States and Canada.

From this registry, Dr. Liao and colleagues identified 1,039 patients with 24 months or more of follow-up data, a confirmed index biologic start date, and valid baseline assessment data, and categorized them into three cohorts:

• 490 (47.2%) with good response (GR), defined as patients with 24 months or more of continued index biologic use by the last registry visit.
• 65 (6.3%) with multiple biologic failure (MBF), defined as patients administered two or more biologic agents of different mechanistic classes who discontinued these biologics because of physician-reported “inadequate initial response,” “failure to maintain initial response,” or “active disease” despite 90 or more days of use per biologic.
• 484 (46.6%) categorized as “other,” defined as patients failed by one biologic or who discontinued treatment for nonmedical reasons.

The researchers used multivariable logistic regression to identify sociodemographic, clinical, and patient-reported outcomes that differed between the MBF and GR groups. The mean age of the patients in the study was 49.1 years, 44.2% were female, 77.9% were White, 9.7% were Hispanic, and the mean duration of psoriasis was 11.5 years.

On multivariable logistic regression, factors associated with MBF, compared with those with GR, included female at birth (odds ratio [OR] = 2.29; confidence interval [CI], 1.11-4.72), history of hyperlipidemia (OR = 3.14; CI, 1.35-7.30), Medicaid insurance (OR = 4.53; CI, 1.40-14.60), prior nonbiologic systemic therapy (OR = 2.47; CI, 1.16-5.25), higher psoriasis duration (OR = 0.60 per standard deviation [SD]; CI, 0.38-0.94), and later index biologic initiation (OR = 0.37 per year; CI, 0.27-0.52). Sensitivity analysis revealed that the duration of prior nonbiologic systemic therapy use was not associated with MBF (OR = 0.99; CI, 0.94-1.02; P = 0.56).

“Interestingly, health-related behaviors (e.g., smoking, alcohol use) and location/extent of psoriasis were not important differentiators between MBF and GR,” the authors noted. “We might suspect these features to correlate with MBF, as numerous observational studies found associations between health-related behaviors or psoriasis severity and presence at difficult-to-treat locations, which often relates to biologic use.”

They acknowledged certain limitations of their study, including underrepresentation of ethnoracial minorities and male sex at birth relative to reported psoriasis epidemiology, “possibly reflecting participation bias and reduced access to specialty care, given that patients were enrolled into the registry by dermatologists,” they wrote. “Patient adherence to prescribed biologic regimens between registry visits was not evaluated.”

Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that despite the rapid expansion in biologic therapies for psoriasis, “analysis of real-world use patterns and patient characteristics has been limited – particularly for those who have failed multiple treatments. These findings suggest that there indeed may be some key differences between patients who have had to cycle through multiple biologics versus those who have had a sustained satisfactory response on a single therapy, such as disease duration and previous nonbiologic treatments.”

Dr. Chovatiya

Female sex, hyperlipidemia, Medicaid insurance, earlier year of biologic initiation, shorter duration of psoriasis, and prior nonbiologic systemic therapy use were associated with multiple biologic failure in patients with psoriasis, results from a prospective cohort demonstrated.

“Prior cross-sectional and single-center studies have primarily analyzed therapeutic failure of a single biologic or biologics within one class,” researchers led by Wilson Liao, MD, professor and vice chair of research in the department of dermatology at the University of California, San Francisco, wrote in the study, published in the Journal of the American Academy of Dermatology. “However, failure of multiple biologics targeting different signaling pathways is common over the course of treatment. These ‘multiple biologic failure’ patients are not well-characterized, and the patterns of biologics attempted and sociodemographic or clinical features that may predict difficult treatment are incompletely studied.”

To bridge this gap, the researchers conducted a prospective cohort study from the CorEvitas Psoriasis Registry, which collected data from dermatologist-diagnosed patients with psoriasis who started or switched to a Food and Drug Administration (FDA)–approved systemic therapy for psoriasis during routine dermatology visits from April 15, 2015, to May 10, 2022. This period included data from 17,196 patients across 259 private and 209 academic sites from 580 physicians in the United States and Canada.

From this registry, Dr. Liao and colleagues identified 1,039 patients with 24 months or more of follow-up data, a confirmed index biologic start date, and valid baseline assessment data, and categorized them into three cohorts:

• 490 (47.2%) with good response (GR), defined as patients with 24 months or more of continued index biologic use by the last registry visit.
• 65 (6.3%) with multiple biologic failure (MBF), defined as patients administered two or more biologic agents of different mechanistic classes who discontinued these biologics because of physician-reported “inadequate initial response,” “failure to maintain initial response,” or “active disease” despite 90 or more days of use per biologic.
• 484 (46.6%) categorized as “other,” defined as patients failed by one biologic or who discontinued treatment for nonmedical reasons.

The researchers used multivariable logistic regression to identify sociodemographic, clinical, and patient-reported outcomes that differed between the MBF and GR groups. The mean age of the patients in the study was 49.1 years, 44.2% were female, 77.9% were White, 9.7% were Hispanic, and the mean duration of psoriasis was 11.5 years.

On multivariable logistic regression, factors associated with MBF, compared with those with GR, included female at birth (odds ratio [OR] = 2.29; confidence interval [CI], 1.11-4.72), history of hyperlipidemia (OR = 3.14; CI, 1.35-7.30), Medicaid insurance (OR = 4.53; CI, 1.40-14.60), prior nonbiologic systemic therapy (OR = 2.47; CI, 1.16-5.25), higher psoriasis duration (OR = 0.60 per standard deviation [SD]; CI, 0.38-0.94), and later index biologic initiation (OR = 0.37 per year; CI, 0.27-0.52). Sensitivity analysis revealed that the duration of prior nonbiologic systemic therapy use was not associated with MBF (OR = 0.99; CI, 0.94-1.02; P = 0.56).

“Interestingly, health-related behaviors (e.g., smoking, alcohol use) and location/extent of psoriasis were not important differentiators between MBF and GR,” the authors noted. “We might suspect these features to correlate with MBF, as numerous observational studies found associations between health-related behaviors or psoriasis severity and presence at difficult-to-treat locations, which often relates to biologic use.”

They acknowledged certain limitations of their study, including underrepresentation of ethnoracial minorities and male sex at birth relative to reported psoriasis epidemiology, “possibly reflecting participation bias and reduced access to specialty care, given that patients were enrolled into the registry by dermatologists,” they wrote. “Patient adherence to prescribed biologic regimens between registry visits was not evaluated.”

Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that despite the rapid expansion in biologic therapies for psoriasis, “analysis of real-world use patterns and patient characteristics has been limited – particularly for those who have failed multiple treatments. These findings suggest that there indeed may be some key differences between patients who have had to cycle through multiple biologics versus those who have had a sustained satisfactory response on a single therapy, such as disease duration and previous nonbiologic treatments.”

Dr. Chovatiya

This transcript has been edited for clarity.

Dr. Patel: A friend recently joked with me and said, “I wish you were a dermatologist so you could hook me up with Botox and fillers.” Well, little does this friend know that I could be a certified cosmetic injector just after a weekend course. Botox parties, here I come?

I can’t blame any health care professional for having a side hustle. People are burned out, want to supplement their income, or scale back clinical hours. According to one Medscape survey, almost 40% of physicians do have some form of a side hustle, whether it is consulting, speaking engagements, being an expert witness, or moonlighting. I know plenty of doctors and nurses who have taken on Botox injecting as a way to make some extra cash.

Now, going back to me and smoothing out wrinkles. I’m a pediatric hospitalist. I’ve never injected an aesthetic product in anyone’s face. When it comes to sharp objects and faces, I’ve sewn lacerations and drained abscesses. In my world, when we talk about botulinum toxin, we’re usually talking about botulism or the therapeutic treatment of migraines and muscle spasms – pathology. But even still, how hard would it actually be for me to go out and get certified to give Botox?

The National Laser Institute has a 2-day Botox and dermal filler training. “Our 2-day Botox and filler course will also teach you how to build a practice and capitalize on the enormous Botox and dermal filler market that exists in the United States.” That’s a lot to cover in 2 days. They even have lunch breaks.

Just from a quick search, I even found an online video course for $1,500. For an additional fee, you can have a live, hands-on component. There are so many trainings out there, including one that’s only 8 hours long, offered by Empire Medical. I also went and spoke with an employee at Empire Medical who told me that because I’m an MD, if I do the course, I can use my certificate and go directly to a manufacturer, buy Botox, and start injecting right away.

Now, is this training actually sufficient for me to go and get good results while minimizing adverse effects like brow ptosis, dry eyes, and asymmetry? I have no idea. According to a review from the Journal of Cosmetic Dermatology, it’s crucial to understand anatomic landmarks, muscle function, baseline asymmetry, potential migration of the toxin, and site-specific precautions.

Okay, that sounds really intimidating, but people still do it. I saw a Business Insider article about a hospitalist who took a 2-day Botox course and then, to her credit, she trained under supervision for an additional 6 months. She then started hosting Botox parties and each time was making $3,500 to upwards of $20,000.

Let’s do some quick mental math. If I were to go online and buy Botox for $3-$6 a unit and then charge patients $15 a unit, and then I consider that in areas like the forehead or in between the eyes – I read that could take 25-50 units – and I repeat this for multiple patients, I can make a few thousand dollars. Well, I may have to adjust my prices according to the market, obviously, because I did see some Groupons advertising $10 per unit.

Who can get in on some Botox cosmetic cash action? Well, physicians can right away. For other health care professionals, it depends on the state. For example, in California, dentists cannot get Botox solely for cosmetic purposes, whereas in Arizona, they can. Generally speaking, NPs and PAs require some type of physician oversight or supervision, but again, it depends on the state.

Oh, and fun fact: Connecticut outright banned Botox parties and said that Botox must be performed “in a medical spa or licensed health care facility and by a Connecticut-licensed health care provider within his or her scope of practice.”

It definitely worries me that someone could go online or go overseas, buy Botox, claim to be a health care professional, and literally commit fraud. I found stories out there such as a couple in San Jose who are giving out Botox from their home without a license. They got arrested. Also, a woman in Alabama who lied about being a licensed dermatologist and did the same, or another woman in Los Angeles who got arrested after selling counterfeit Botox to undercover law enforcement. Surely, there are plenty more cases out there like this.

I asked Dr. Jacqueline Watchmaker, a board-certified dermatologist at U.S. Dermatology Partners in Arizona who has an expertise in cosmetic procedures, what she thought about the booming med spa industry and what, if any, regulatory changes she wanted to see.

Jacqueline Watchmaker, MD: I do think the fact that people can just go to a 1- or 2-day injection course and inject filler and Botox is concerning. I think the lack of regulation surrounding this topic is also very concerning.

There’s so much that goes into being a skilled injector. It’s an intricate knowledge of facial anatomy, which takes weeks, if not months, to really master. There’s actually injection technique, which can be very complex depending on the part of the face that you’re injecting. Even more important, it’s how to prevent complications, but also how to deal with complications if they do occur. There’s no way that these weekend injection courses are able to cover those topics in a thorough and satisfactory manner.

I see complications from med spas all the time, and I think it’s people going to injectors who are not skilled. They don’t know their anatomy, they don’t know the appropriate filler to use, and then heaven forbid there is a complication, they don’t know how to manage the complication – and then those patients get sent to me.

I think patients sometimes forget that these cosmetic procedures are true medical procedures. You need sterile technique. Again, you need to know the anatomy. It can look easy on social media, but there’s a large amount of thought behind it. I think there needs to be more regulation around this topic.

Dr. Patel: In one study, out of 400 people who received a cosmetic procedure, 50 reported an adverse event, such as discoloration or burns, and these adverse events were more likely to occur if a nonphysician was doing the procedure. Granted, this was a small study. You can’t make a generalization out of it, but this does add to the argument that there needs to be more regulation and oversight.

Let’s be real. The cosmetic injection side hustle is alive and well, but I’m good. I’m not going there. Maybe there should be some more quality control. At Botox parties, do people even ask if their injectors are certified or where they bought their vials?

You might be thinking that this isn’t a big deal because it’s just Botox. Let me ask you all a question: If you or your family member were going to go get Botox or another cosmetic injection, would it still not be a big deal?

Dr. Patel is a pediatric hospitalist, television producer, media contributor, and digital health enthusiast. He splits his time between New York City and San Francisco, as he is on faculty at Columbia University/Morgan Stanley Children’s Hospital and UCSF Benioff Children’s Hospital. He reported conflicts of interest with Medumo.

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

This transcript has been edited for clarity.

Dr. Patel: A friend recently joked with me and said, “I wish you were a dermatologist so you could hook me up with Botox and fillers.” Well, little does this friend know that I could be a certified cosmetic injector just after a weekend course. Botox parties, here I come?

I can’t blame any health care professional for having a side hustle. People are burned out, want to supplement their income, or scale back clinical hours. According to one Medscape survey, almost 40% of physicians do have some form of a side hustle, whether it is consulting, speaking engagements, being an expert witness, or moonlighting. I know plenty of doctors and nurses who have taken on Botox injecting as a way to make some extra cash.

Now, going back to me and smoothing out wrinkles. I’m a pediatric hospitalist. I’ve never injected an aesthetic product in anyone’s face. When it comes to sharp objects and faces, I’ve sewn lacerations and drained abscesses. In my world, when we talk about botulinum toxin, we’re usually talking about botulism or the therapeutic treatment of migraines and muscle spasms – pathology. But even still, how hard would it actually be for me to go out and get certified to give Botox?

The National Laser Institute has a 2-day Botox and dermal filler training. “Our 2-day Botox and filler course will also teach you how to build a practice and capitalize on the enormous Botox and dermal filler market that exists in the United States.” That’s a lot to cover in 2 days. They even have lunch breaks.

Just from a quick search, I even found an online video course for $1,500. For an additional fee, you can have a live, hands-on component. There are so many trainings out there, including one that’s only 8 hours long, offered by Empire Medical. I also went and spoke with an employee at Empire Medical who told me that because I’m an MD, if I do the course, I can use my certificate and go directly to a manufacturer, buy Botox, and start injecting right away.

Now, is this training actually sufficient for me to go and get good results while minimizing adverse effects like brow ptosis, dry eyes, and asymmetry? I have no idea. According to a review from the Journal of Cosmetic Dermatology, it’s crucial to understand anatomic landmarks, muscle function, baseline asymmetry, potential migration of the toxin, and site-specific precautions.

Okay, that sounds really intimidating, but people still do it. I saw a Business Insider article about a hospitalist who took a 2-day Botox course and then, to her credit, she trained under supervision for an additional 6 months. She then started hosting Botox parties and each time was making $3,500 to upwards of $20,000.

Let’s do some quick mental math. If I were to go online and buy Botox for $3-$6 a unit and then charge patients $15 a unit, and then I consider that in areas like the forehead or in between the eyes – I read that could take 25-50 units – and I repeat this for multiple patients, I can make a few thousand dollars. Well, I may have to adjust my prices according to the market, obviously, because I did see some Groupons advertising $10 per unit.

Who can get in on some Botox cosmetic cash action? Well, physicians can right away. For other health care professionals, it depends on the state. For example, in California, dentists cannot get Botox solely for cosmetic purposes, whereas in Arizona, they can. Generally speaking, NPs and PAs require some type of physician oversight or supervision, but again, it depends on the state.

Oh, and fun fact: Connecticut outright banned Botox parties and said that Botox must be performed “in a medical spa or licensed health care facility and by a Connecticut-licensed health care provider within his or her scope of practice.”

It definitely worries me that someone could go online or go overseas, buy Botox, claim to be a health care professional, and literally commit fraud. I found stories out there such as a couple in San Jose who are giving out Botox from their home without a license. They got arrested. Also, a woman in Alabama who lied about being a licensed dermatologist and did the same, or another woman in Los Angeles who got arrested after selling counterfeit Botox to undercover law enforcement. Surely, there are plenty more cases out there like this.

I asked Dr. Jacqueline Watchmaker, a board-certified dermatologist at U.S. Dermatology Partners in Arizona who has an expertise in cosmetic procedures, what she thought about the booming med spa industry and what, if any, regulatory changes she wanted to see.

Jacqueline Watchmaker, MD: I do think the fact that people can just go to a 1- or 2-day injection course and inject filler and Botox is concerning. I think the lack of regulation surrounding this topic is also very concerning.

There’s so much that goes into being a skilled injector. It’s an intricate knowledge of facial anatomy, which takes weeks, if not months, to really master. There’s actually injection technique, which can be very complex depending on the part of the face that you’re injecting. Even more important, it’s how to prevent complications, but also how to deal with complications if they do occur. There’s no way that these weekend injection courses are able to cover those topics in a thorough and satisfactory manner.

I see complications from med spas all the time, and I think it’s people going to injectors who are not skilled. They don’t know their anatomy, they don’t know the appropriate filler to use, and then heaven forbid there is a complication, they don’t know how to manage the complication – and then those patients get sent to me.

I think patients sometimes forget that these cosmetic procedures are true medical procedures. You need sterile technique. Again, you need to know the anatomy. It can look easy on social media, but there’s a large amount of thought behind it. I think there needs to be more regulation around this topic.

Dr. Patel: In one study, out of 400 people who received a cosmetic procedure, 50 reported an adverse event, such as discoloration or burns, and these adverse events were more likely to occur if a nonphysician was doing the procedure. Granted, this was a small study. You can’t make a generalization out of it, but this does add to the argument that there needs to be more regulation and oversight.

Let’s be real. The cosmetic injection side hustle is alive and well, but I’m good. I’m not going there. Maybe there should be some more quality control. At Botox parties, do people even ask if their injectors are certified or where they bought their vials?

You might be thinking that this isn’t a big deal because it’s just Botox. Let me ask you all a question: If you or your family member were going to go get Botox or another cosmetic injection, would it still not be a big deal?

Dr. Patel is a pediatric hospitalist, television producer, media contributor, and digital health enthusiast. He splits his time between New York City and San Francisco, as he is on faculty at Columbia University/Morgan Stanley Children’s Hospital and UCSF Benioff Children’s Hospital. He reported conflicts of interest with Medumo.

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

This transcript has been edited for clarity.

Dr. Patel: A friend recently joked with me and said, “I wish you were a dermatologist so you could hook me up with Botox and fillers.” Well, little does this friend know that I could be a certified cosmetic injector just after a weekend course. Botox parties, here I come?

I can’t blame any health care professional for having a side hustle. People are burned out, want to supplement their income, or scale back clinical hours. According to one Medscape survey, almost 40% of physicians do have some form of a side hustle, whether it is consulting, speaking engagements, being an expert witness, or moonlighting. I know plenty of doctors and nurses who have taken on Botox injecting as a way to make some extra cash.

Now, going back to me and smoothing out wrinkles. I’m a pediatric hospitalist. I’ve never injected an aesthetic product in anyone’s face. When it comes to sharp objects and faces, I’ve sewn lacerations and drained abscesses. In my world, when we talk about botulinum toxin, we’re usually talking about botulism or the therapeutic treatment of migraines and muscle spasms – pathology. But even still, how hard would it actually be for me to go out and get certified to give Botox?

The National Laser Institute has a 2-day Botox and dermal filler training. “Our 2-day Botox and filler course will also teach you how to build a practice and capitalize on the enormous Botox and dermal filler market that exists in the United States.” That’s a lot to cover in 2 days. They even have lunch breaks.

Just from a quick search, I even found an online video course for $1,500. For an additional fee, you can have a live, hands-on component. There are so many trainings out there, including one that’s only 8 hours long, offered by Empire Medical. I also went and spoke with an employee at Empire Medical who told me that because I’m an MD, if I do the course, I can use my certificate and go directly to a manufacturer, buy Botox, and start injecting right away.

Now, is this training actually sufficient for me to go and get good results while minimizing adverse effects like brow ptosis, dry eyes, and asymmetry? I have no idea. According to a review from the Journal of Cosmetic Dermatology, it’s crucial to understand anatomic landmarks, muscle function, baseline asymmetry, potential migration of the toxin, and site-specific precautions.

Okay, that sounds really intimidating, but people still do it. I saw a Business Insider article about a hospitalist who took a 2-day Botox course and then, to her credit, she trained under supervision for an additional 6 months. She then started hosting Botox parties and each time was making $3,500 to upwards of $20,000.

Let’s do some quick mental math. If I were to go online and buy Botox for $3-$6 a unit and then charge patients $15 a unit, and then I consider that in areas like the forehead or in between the eyes – I read that could take 25-50 units – and I repeat this for multiple patients, I can make a few thousand dollars. Well, I may have to adjust my prices according to the market, obviously, because I did see some Groupons advertising $10 per unit.

Who can get in on some Botox cosmetic cash action? Well, physicians can right away. For other health care professionals, it depends on the state. For example, in California, dentists cannot get Botox solely for cosmetic purposes, whereas in Arizona, they can. Generally speaking, NPs and PAs require some type of physician oversight or supervision, but again, it depends on the state.

Oh, and fun fact: Connecticut outright banned Botox parties and said that Botox must be performed “in a medical spa or licensed health care facility and by a Connecticut-licensed health care provider within his or her scope of practice.”

It definitely worries me that someone could go online or go overseas, buy Botox, claim to be a health care professional, and literally commit fraud. I found stories out there such as a couple in San Jose who are giving out Botox from their home without a license. They got arrested. Also, a woman in Alabama who lied about being a licensed dermatologist and did the same, or another woman in Los Angeles who got arrested after selling counterfeit Botox to undercover law enforcement. Surely, there are plenty more cases out there like this.

I asked Dr. Jacqueline Watchmaker, a board-certified dermatologist at U.S. Dermatology Partners in Arizona who has an expertise in cosmetic procedures, what she thought about the booming med spa industry and what, if any, regulatory changes she wanted to see.

Jacqueline Watchmaker, MD: I do think the fact that people can just go to a 1- or 2-day injection course and inject filler and Botox is concerning. I think the lack of regulation surrounding this topic is also very concerning.

There’s so much that goes into being a skilled injector. It’s an intricate knowledge of facial anatomy, which takes weeks, if not months, to really master. There’s actually injection technique, which can be very complex depending on the part of the face that you’re injecting. Even more important, it’s how to prevent complications, but also how to deal with complications if they do occur. There’s no way that these weekend injection courses are able to cover those topics in a thorough and satisfactory manner.

I see complications from med spas all the time, and I think it’s people going to injectors who are not skilled. They don’t know their anatomy, they don’t know the appropriate filler to use, and then heaven forbid there is a complication, they don’t know how to manage the complication – and then those patients get sent to me.

I think patients sometimes forget that these cosmetic procedures are true medical procedures. You need sterile technique. Again, you need to know the anatomy. It can look easy on social media, but there’s a large amount of thought behind it. I think there needs to be more regulation around this topic.

Dr. Patel: In one study, out of 400 people who received a cosmetic procedure, 50 reported an adverse event, such as discoloration or burns, and these adverse events were more likely to occur if a nonphysician was doing the procedure. Granted, this was a small study. You can’t make a generalization out of it, but this does add to the argument that there needs to be more regulation and oversight.

Let’s be real. The cosmetic injection side hustle is alive and well, but I’m good. I’m not going there. Maybe there should be some more quality control. At Botox parties, do people even ask if their injectors are certified or where they bought their vials?

You might be thinking that this isn’t a big deal because it’s just Botox. Let me ask you all a question: If you or your family member were going to go get Botox or another cosmetic injection, would it still not be a big deal?

Dr. Patel is a pediatric hospitalist, television producer, media contributor, and digital health enthusiast. He splits his time between New York City and San Francisco, as he is on faculty at Columbia University/Morgan Stanley Children’s Hospital and UCSF Benioff Children’s Hospital. He reported conflicts of interest with Medumo.

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

A teledermatology clinic program established in Ward 8 of Washington, D.C., to help residents learn about and initiate care for atopic dermatitis (AD) has garnered high patient satisfaction marks and may serve as a model for similar clinics in other underserved areas in the United States.

Washington, D.C., has “staggering health disparities that are among the largest in the country,” and Ward 8 and surrounding areas in the southeastern part of the city are “dermatology deserts,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who started the program in 2021 with a pilot project. Dr. Friedman spoke about the project, which has since been expanded to include alopecia areata, at the Revolutionizing Atopic Dermatitis conference in April and in an interview after the meeting.

Patients who attend the clinics – held at the Temple of Praise Church in a residential area of Ward 8, a predominantly Black community with a 30% poverty rate – are entered into the GW Medical Faculty Associates medical records system and educated on telemedicine best practices (such as not having light behind them during a session) and how to use telemedicine with their own device.

Those with AD who participate learn about the condition through an image-rich poster showing how it appears in various skin tones, handouts, National Eczema Association films, and discussion with medical students who staff the clinics under Dr. Friedman’s on-site supervision. Participants with alopecia areata similarly can view a poster and converse about the condition.

Patients then have a free 20-minute telehealth visit with a GWU dermatology resident in a private room, and a medical student volunteer nearby to assist with the technology if needed. They leave with a treatment plan, which often includes prescriptions, and a follow-up telemedicine appointment.

The program “is meant to be a stepping point for initiating care ... to set someone up for success for recurrent telehealth visits in the future” and for treatment before symptoms become too severe, Dr. Friedman said in an interview. “We want to demystify telemedicine and educate on the disease state and dispel myths ... so the patient understands why it’s happening” and how it can be treated.

Dr. Adam Friedman

The pilot project, funded with a grant from Pfizer, involved five 2-hour clinics held on Mondays from 4 p.m. to 6 p.m., that together served almost 50 adult and pediatric patients. Grants from Pfizer and Eli Lilly enabled additional clinics in the spring of 2023 and into the summer. And in June, GWU and Pfizer announced a $1 million national grant program focused on broad implementation of what they’ve coined the “Teledermatology Help Desk Clinic” model.

Practices or organizations that secure grants will utilize GWU’s experience and meet with an advisory council of experts in dermatology telemedicine and community advocacy. Having a “long-term plan” and commitment to sustainability is an important element of the model, said Dr. Friedman, who is chairing the grant program.


 

Patients deem clinic ‘extremely’ helpful

As one of the most prevalent skin disorders – and one with a documented history of elevated risk for specific populations – AD was a good starting point for the teledermatology clinic program. Patients who identify as Black have a higher incidence and prevalence of AD than those who identify as White and Hispanic, and they tend to have more severe disease. Yet they account for fewer visits to dermatologists for AD.

One cross-sectional study of about 3,500 adults in the United States with AD documented that racial/ethnic and socioeconomic disparities reduce outpatient utilization of AD care and increase urgent care and hospital utilization. And in a longitudinal cohort study of children in the United States with AD, Black children with poorly controlled AD were significantly less likely than White children to see a dermatologist.

Dr. Adam Friedman

Like other programs, the GWU department of dermatology had pivoted to telehealth in 2020, and a published survey of patients who attended telehealth appointments during the early part of the pandemic showed that it was generally well liked – and not only for social distancing, but for time efficiency and because transportation was not needed. Only 10% of the 168 patients who completed the survey (out of 894 asked) reported they were unlikely to undertake another telehealth visit. For 10%, eczema was the reason for the visit.

However, only 1% of the survey respondents were from Ward 8, which “begged the question, did those who really need access know this was an option?” Dr. Friedman said at the RAD meeting. He wondered whether there was not only a dermatology desert in Ward 8, but a “technology desert” as well.

Findings from a patient satisfaction survey taken at the end of the pilot program are encouraging, Dr. Friedman said. While data on follow-up visits has not been collected yet, “what I do now have a sense of” is that “the entry point [afforded by the clinics] changed the course in terms of patients’ understanding of the disease and how they feel about its management.”

Dr. Adam Friedman

About 94% of survey respondents indicated the clinic was “extremely” helpful and the remainder said it was “very” helpful; 90% said telehealth significantly changed how they will manage their condition; and 97% said it is “extremely” important to continue the clinics. The majority of patients – 70% – indicated they did not have a dermatologist.

Education about AD at the clinics covers moisturizers/emollients, bathing habits, soaps and detergents, trigger avoidance, and the role of stress and environmental factors in disease exacerbation. Trade samples of moisturizers, mild cleansers, and other products have increasingly been available.

For prescriptions of topical steroids and other commonly prescribed medications, Dr. Friedman and associates combed GoodRx for coupons and surveyed local pharmacies for self-pay pricing to identify least expensive options. Patients with AD who were deemed likely candidates for more advanced therapies in the future were educated about these possibilities.
 

Alopecia areata

The addition of alopecia areata drew patients with other forms of hair loss as well, but “we weren’t going to turn anyone away who did not have that specific autoimmune form of hair loss,” Dr. Friedman said. Depending on the diagnosis, prescriptions were written for minoxidil and 5-alpha reductase inhibitors.

Important for follow-up is GWU’s acceptance of Medicaid and the availability of both a sliding scale for self-pay and services that assist patients in registering for Medicaid and, if eligible, other insurance plans.
 

Building partnerships, earning trust

Establishment of the teledermatology clinic program took legwork and relationship building. “You can’t just show up. That’s not enough,” said Dr. Friedman, who also directs the dermatology residency program at GWU. “You have to show through action and through investment of time and energy that you are legitimate, that you’re really there for the long haul.”

Dr. Adam Friedman

Dr. Friedman had assistance from the Rodham Institute, which was established at GWU (and until recently was housed there) and has a history of engagement with local stakeholders such as community centers, church leadership, politicians, and others in the Washington area. He was put in touch with Bishop Deborah Webb at the Temple of Praise Church, a community pillar in Ward 8, and from there “it was a courtship,” he said, with trust to be built and logistics to be worked out. (Budgets for the clinics, he noted, have included compensation to the church and gift cards for church volunteers who are present at the clinics.)

In the meantime, medical student volunteers from GWU, Howard University, and Georgetown University were trained in telemedicine and attended a “boot camp” on AD “so they’d be able to talk with anyone about it,” Dr. Friedman said.

Advertising “was a learning experience,” he said, and was ultimately multipronged, involving church service announcements, flyers, and, most importantly, Facebook and Instagram advertisements. (People were asked to call a dedicated phone line to schedule an appointment and were invited to register in the GW Medical Faculty Associates records system, though walk-ins to the clinics were still welcomed.)

In a comment, Misty Eleryan, MD, MS, a Mohs micrographic surgeon and dermatologist in Santa Monica, Calif., said dermatology deserts are often found in rural areas and/or areas “with a higher population of marginalized communities, such as Black, Brown, or poorer individuals” – communities that tend to rely on care from urgent care or ED physicians who are unaware of how skin conditions present on darker skin tones.

Programs that educate patients about various presentations of skin conditions are helpful not only for the patients themselves, but could also enable them to help friends, family members, and colleagues, said Dr. Eleryan, who did her residency training at GWU.

“Access,” she noted, is more than just physical access to a person, place, or thing. Referring to a “five A’s” framework described several decades ago, Dr. Eleryan said access to care is characterized by affordability, availability (extent to which the physician has the requisite resources, such as personnel and technology, to meet the patient’s needs), accessibility (geographic), accommodation (extent to which the physician can meet the patient’s constraints and preferences – such as hours of operation, how communications are handled, ability to receive care without prior appointments), and acceptability (extent to which the patient is comfortable with the “more immutable characteristics” of the physician and vice versa).

The GWU program, she said, “is a great start.”

Dr. Friedman said he’s fully invested. There has long been a perception, “rightfully so, that underserved communities are overlooked especially by large institutions. One attendee told me she never expected in her lifetime to see something like this clinic and someone who looked like me caring about her community. ... It certainly says a great deal about the work we need to put in to repair longstanding injury.”

Dr. Friedman disclosed that, in addition to being a recipient of grants from Pfizer and Lilly, he is a speaker for Lilly. Dr. Eleryan said she has no relevant disclosures.

A teledermatology clinic program established in Ward 8 of Washington, D.C., to help residents learn about and initiate care for atopic dermatitis (AD) has garnered high patient satisfaction marks and may serve as a model for similar clinics in other underserved areas in the United States.

Washington, D.C., has “staggering health disparities that are among the largest in the country,” and Ward 8 and surrounding areas in the southeastern part of the city are “dermatology deserts,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who started the program in 2021 with a pilot project. Dr. Friedman spoke about the project, which has since been expanded to include alopecia areata, at the Revolutionizing Atopic Dermatitis conference in April and in an interview after the meeting.

Patients who attend the clinics – held at the Temple of Praise Church in a residential area of Ward 8, a predominantly Black community with a 30% poverty rate – are entered into the GW Medical Faculty Associates medical records system and educated on telemedicine best practices (such as not having light behind them during a session) and how to use telemedicine with their own device.

Those with AD who participate learn about the condition through an image-rich poster showing how it appears in various skin tones, handouts, National Eczema Association films, and discussion with medical students who staff the clinics under Dr. Friedman’s on-site supervision. Participants with alopecia areata similarly can view a poster and converse about the condition.

Patients then have a free 20-minute telehealth visit with a GWU dermatology resident in a private room, and a medical student volunteer nearby to assist with the technology if needed. They leave with a treatment plan, which often includes prescriptions, and a follow-up telemedicine appointment.

The program “is meant to be a stepping point for initiating care ... to set someone up for success for recurrent telehealth visits in the future” and for treatment before symptoms become too severe, Dr. Friedman said in an interview. “We want to demystify telemedicine and educate on the disease state and dispel myths ... so the patient understands why it’s happening” and how it can be treated.

Dr. Adam Friedman

The pilot project, funded with a grant from Pfizer, involved five 2-hour clinics held on Mondays from 4 p.m. to 6 p.m., that together served almost 50 adult and pediatric patients. Grants from Pfizer and Eli Lilly enabled additional clinics in the spring of 2023 and into the summer. And in June, GWU and Pfizer announced a $1 million national grant program focused on broad implementation of what they’ve coined the “Teledermatology Help Desk Clinic” model.

Practices or organizations that secure grants will utilize GWU’s experience and meet with an advisory council of experts in dermatology telemedicine and community advocacy. Having a “long-term plan” and commitment to sustainability is an important element of the model, said Dr. Friedman, who is chairing the grant program.


 

Patients deem clinic ‘extremely’ helpful

As one of the most prevalent skin disorders – and one with a documented history of elevated risk for specific populations – AD was a good starting point for the teledermatology clinic program. Patients who identify as Black have a higher incidence and prevalence of AD than those who identify as White and Hispanic, and they tend to have more severe disease. Yet they account for fewer visits to dermatologists for AD.

One cross-sectional study of about 3,500 adults in the United States with AD documented that racial/ethnic and socioeconomic disparities reduce outpatient utilization of AD care and increase urgent care and hospital utilization. And in a longitudinal cohort study of children in the United States with AD, Black children with poorly controlled AD were significantly less likely than White children to see a dermatologist.

Dr. Adam Friedman

Like other programs, the GWU department of dermatology had pivoted to telehealth in 2020, and a published survey of patients who attended telehealth appointments during the early part of the pandemic showed that it was generally well liked – and not only for social distancing, but for time efficiency and because transportation was not needed. Only 10% of the 168 patients who completed the survey (out of 894 asked) reported they were unlikely to undertake another telehealth visit. For 10%, eczema was the reason for the visit.

However, only 1% of the survey respondents were from Ward 8, which “begged the question, did those who really need access know this was an option?” Dr. Friedman said at the RAD meeting. He wondered whether there was not only a dermatology desert in Ward 8, but a “technology desert” as well.

Findings from a patient satisfaction survey taken at the end of the pilot program are encouraging, Dr. Friedman said. While data on follow-up visits has not been collected yet, “what I do now have a sense of” is that “the entry point [afforded by the clinics] changed the course in terms of patients’ understanding of the disease and how they feel about its management.”

Dr. Adam Friedman

About 94% of survey respondents indicated the clinic was “extremely” helpful and the remainder said it was “very” helpful; 90% said telehealth significantly changed how they will manage their condition; and 97% said it is “extremely” important to continue the clinics. The majority of patients – 70% – indicated they did not have a dermatologist.

Education about AD at the clinics covers moisturizers/emollients, bathing habits, soaps and detergents, trigger avoidance, and the role of stress and environmental factors in disease exacerbation. Trade samples of moisturizers, mild cleansers, and other products have increasingly been available.

For prescriptions of topical steroids and other commonly prescribed medications, Dr. Friedman and associates combed GoodRx for coupons and surveyed local pharmacies for self-pay pricing to identify least expensive options. Patients with AD who were deemed likely candidates for more advanced therapies in the future were educated about these possibilities.
 

Alopecia areata

The addition of alopecia areata drew patients with other forms of hair loss as well, but “we weren’t going to turn anyone away who did not have that specific autoimmune form of hair loss,” Dr. Friedman said. Depending on the diagnosis, prescriptions were written for minoxidil and 5-alpha reductase inhibitors.

Important for follow-up is GWU’s acceptance of Medicaid and the availability of both a sliding scale for self-pay and services that assist patients in registering for Medicaid and, if eligible, other insurance plans.
 

Building partnerships, earning trust

Establishment of the teledermatology clinic program took legwork and relationship building. “You can’t just show up. That’s not enough,” said Dr. Friedman, who also directs the dermatology residency program at GWU. “You have to show through action and through investment of time and energy that you are legitimate, that you’re really there for the long haul.”

Dr. Adam Friedman

Dr. Friedman had assistance from the Rodham Institute, which was established at GWU (and until recently was housed there) and has a history of engagement with local stakeholders such as community centers, church leadership, politicians, and others in the Washington area. He was put in touch with Bishop Deborah Webb at the Temple of Praise Church, a community pillar in Ward 8, and from there “it was a courtship,” he said, with trust to be built and logistics to be worked out. (Budgets for the clinics, he noted, have included compensation to the church and gift cards for church volunteers who are present at the clinics.)

In the meantime, medical student volunteers from GWU, Howard University, and Georgetown University were trained in telemedicine and attended a “boot camp” on AD “so they’d be able to talk with anyone about it,” Dr. Friedman said.

Advertising “was a learning experience,” he said, and was ultimately multipronged, involving church service announcements, flyers, and, most importantly, Facebook and Instagram advertisements. (People were asked to call a dedicated phone line to schedule an appointment and were invited to register in the GW Medical Faculty Associates records system, though walk-ins to the clinics were still welcomed.)

In a comment, Misty Eleryan, MD, MS, a Mohs micrographic surgeon and dermatologist in Santa Monica, Calif., said dermatology deserts are often found in rural areas and/or areas “with a higher population of marginalized communities, such as Black, Brown, or poorer individuals” – communities that tend to rely on care from urgent care or ED physicians who are unaware of how skin conditions present on darker skin tones.

Programs that educate patients about various presentations of skin conditions are helpful not only for the patients themselves, but could also enable them to help friends, family members, and colleagues, said Dr. Eleryan, who did her residency training at GWU.

“Access,” she noted, is more than just physical access to a person, place, or thing. Referring to a “five A’s” framework described several decades ago, Dr. Eleryan said access to care is characterized by affordability, availability (extent to which the physician has the requisite resources, such as personnel and technology, to meet the patient’s needs), accessibility (geographic), accommodation (extent to which the physician can meet the patient’s constraints and preferences – such as hours of operation, how communications are handled, ability to receive care without prior appointments), and acceptability (extent to which the patient is comfortable with the “more immutable characteristics” of the physician and vice versa).

The GWU program, she said, “is a great start.”

Dr. Friedman said he’s fully invested. There has long been a perception, “rightfully so, that underserved communities are overlooked especially by large institutions. One attendee told me she never expected in her lifetime to see something like this clinic and someone who looked like me caring about her community. ... It certainly says a great deal about the work we need to put in to repair longstanding injury.”

Dr. Friedman disclosed that, in addition to being a recipient of grants from Pfizer and Lilly, he is a speaker for Lilly. Dr. Eleryan said she has no relevant disclosures.

A teledermatology clinic program established in Ward 8 of Washington, D.C., to help residents learn about and initiate care for atopic dermatitis (AD) has garnered high patient satisfaction marks and may serve as a model for similar clinics in other underserved areas in the United States.

Washington, D.C., has “staggering health disparities that are among the largest in the country,” and Ward 8 and surrounding areas in the southeastern part of the city are “dermatology deserts,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who started the program in 2021 with a pilot project. Dr. Friedman spoke about the project, which has since been expanded to include alopecia areata, at the Revolutionizing Atopic Dermatitis conference in April and in an interview after the meeting.

Patients who attend the clinics – held at the Temple of Praise Church in a residential area of Ward 8, a predominantly Black community with a 30% poverty rate – are entered into the GW Medical Faculty Associates medical records system and educated on telemedicine best practices (such as not having light behind them during a session) and how to use telemedicine with their own device.

Those with AD who participate learn about the condition through an image-rich poster showing how it appears in various skin tones, handouts, National Eczema Association films, and discussion with medical students who staff the clinics under Dr. Friedman’s on-site supervision. Participants with alopecia areata similarly can view a poster and converse about the condition.

Patients then have a free 20-minute telehealth visit with a GWU dermatology resident in a private room, and a medical student volunteer nearby to assist with the technology if needed. They leave with a treatment plan, which often includes prescriptions, and a follow-up telemedicine appointment.

The program “is meant to be a stepping point for initiating care ... to set someone up for success for recurrent telehealth visits in the future” and for treatment before symptoms become too severe, Dr. Friedman said in an interview. “We want to demystify telemedicine and educate on the disease state and dispel myths ... so the patient understands why it’s happening” and how it can be treated.

Dr. Adam Friedman

The pilot project, funded with a grant from Pfizer, involved five 2-hour clinics held on Mondays from 4 p.m. to 6 p.m., that together served almost 50 adult and pediatric patients. Grants from Pfizer and Eli Lilly enabled additional clinics in the spring of 2023 and into the summer. And in June, GWU and Pfizer announced a $1 million national grant program focused on broad implementation of what they’ve coined the “Teledermatology Help Desk Clinic” model.

Practices or organizations that secure grants will utilize GWU’s experience and meet with an advisory council of experts in dermatology telemedicine and community advocacy. Having a “long-term plan” and commitment to sustainability is an important element of the model, said Dr. Friedman, who is chairing the grant program.


 

Patients deem clinic ‘extremely’ helpful

As one of the most prevalent skin disorders – and one with a documented history of elevated risk for specific populations – AD was a good starting point for the teledermatology clinic program. Patients who identify as Black have a higher incidence and prevalence of AD than those who identify as White and Hispanic, and they tend to have more severe disease. Yet they account for fewer visits to dermatologists for AD.

One cross-sectional study of about 3,500 adults in the United States with AD documented that racial/ethnic and socioeconomic disparities reduce outpatient utilization of AD care and increase urgent care and hospital utilization. And in a longitudinal cohort study of children in the United States with AD, Black children with poorly controlled AD were significantly less likely than White children to see a dermatologist.

Dr. Adam Friedman

Like other programs, the GWU department of dermatology had pivoted to telehealth in 2020, and a published survey of patients who attended telehealth appointments during the early part of the pandemic showed that it was generally well liked – and not only for social distancing, but for time efficiency and because transportation was not needed. Only 10% of the 168 patients who completed the survey (out of 894 asked) reported they were unlikely to undertake another telehealth visit. For 10%, eczema was the reason for the visit.

However, only 1% of the survey respondents were from Ward 8, which “begged the question, did those who really need access know this was an option?” Dr. Friedman said at the RAD meeting. He wondered whether there was not only a dermatology desert in Ward 8, but a “technology desert” as well.

Findings from a patient satisfaction survey taken at the end of the pilot program are encouraging, Dr. Friedman said. While data on follow-up visits has not been collected yet, “what I do now have a sense of” is that “the entry point [afforded by the clinics] changed the course in terms of patients’ understanding of the disease and how they feel about its management.”

Dr. Adam Friedman

About 94% of survey respondents indicated the clinic was “extremely” helpful and the remainder said it was “very” helpful; 90% said telehealth significantly changed how they will manage their condition; and 97% said it is “extremely” important to continue the clinics. The majority of patients – 70% – indicated they did not have a dermatologist.

Education about AD at the clinics covers moisturizers/emollients, bathing habits, soaps and detergents, trigger avoidance, and the role of stress and environmental factors in disease exacerbation. Trade samples of moisturizers, mild cleansers, and other products have increasingly been available.

For prescriptions of topical steroids and other commonly prescribed medications, Dr. Friedman and associates combed GoodRx for coupons and surveyed local pharmacies for self-pay pricing to identify least expensive options. Patients with AD who were deemed likely candidates for more advanced therapies in the future were educated about these possibilities.
 

Alopecia areata

The addition of alopecia areata drew patients with other forms of hair loss as well, but “we weren’t going to turn anyone away who did not have that specific autoimmune form of hair loss,” Dr. Friedman said. Depending on the diagnosis, prescriptions were written for minoxidil and 5-alpha reductase inhibitors.

Important for follow-up is GWU’s acceptance of Medicaid and the availability of both a sliding scale for self-pay and services that assist patients in registering for Medicaid and, if eligible, other insurance plans.
 

Building partnerships, earning trust

Establishment of the teledermatology clinic program took legwork and relationship building. “You can’t just show up. That’s not enough,” said Dr. Friedman, who also directs the dermatology residency program at GWU. “You have to show through action and through investment of time and energy that you are legitimate, that you’re really there for the long haul.”

Dr. Adam Friedman

Dr. Friedman had assistance from the Rodham Institute, which was established at GWU (and until recently was housed there) and has a history of engagement with local stakeholders such as community centers, church leadership, politicians, and others in the Washington area. He was put in touch with Bishop Deborah Webb at the Temple of Praise Church, a community pillar in Ward 8, and from there “it was a courtship,” he said, with trust to be built and logistics to be worked out. (Budgets for the clinics, he noted, have included compensation to the church and gift cards for church volunteers who are present at the clinics.)

In the meantime, medical student volunteers from GWU, Howard University, and Georgetown University were trained in telemedicine and attended a “boot camp” on AD “so they’d be able to talk with anyone about it,” Dr. Friedman said.

Advertising “was a learning experience,” he said, and was ultimately multipronged, involving church service announcements, flyers, and, most importantly, Facebook and Instagram advertisements. (People were asked to call a dedicated phone line to schedule an appointment and were invited to register in the GW Medical Faculty Associates records system, though walk-ins to the clinics were still welcomed.)

In a comment, Misty Eleryan, MD, MS, a Mohs micrographic surgeon and dermatologist in Santa Monica, Calif., said dermatology deserts are often found in rural areas and/or areas “with a higher population of marginalized communities, such as Black, Brown, or poorer individuals” – communities that tend to rely on care from urgent care or ED physicians who are unaware of how skin conditions present on darker skin tones.

Programs that educate patients about various presentations of skin conditions are helpful not only for the patients themselves, but could also enable them to help friends, family members, and colleagues, said Dr. Eleryan, who did her residency training at GWU.

“Access,” she noted, is more than just physical access to a person, place, or thing. Referring to a “five A’s” framework described several decades ago, Dr. Eleryan said access to care is characterized by affordability, availability (extent to which the physician has the requisite resources, such as personnel and technology, to meet the patient’s needs), accessibility (geographic), accommodation (extent to which the physician can meet the patient’s constraints and preferences – such as hours of operation, how communications are handled, ability to receive care without prior appointments), and acceptability (extent to which the patient is comfortable with the “more immutable characteristics” of the physician and vice versa).

The GWU program, she said, “is a great start.”

Dr. Friedman said he’s fully invested. There has long been a perception, “rightfully so, that underserved communities are overlooked especially by large institutions. One attendee told me she never expected in her lifetime to see something like this clinic and someone who looked like me caring about her community. ... It certainly says a great deal about the work we need to put in to repair longstanding injury.”

Dr. Friedman disclosed that, in addition to being a recipient of grants from Pfizer and Lilly, he is a speaker for Lilly. Dr. Eleryan said she has no relevant disclosures.

The patient’s toenail thickening appeared consistent with possible onychomycosis—but in addition, there was a marked inflammatory and vesicular eruption consistent with an allergic contact dermatitis.

TTO, also known as melaleuca oil, is a popular product used to treat many disorders including alopecia, seborrheic dermatitis, and onychomycosis.¹ Unfortunately, it is a complex compound, and the rate of positive reactions to patch testing ranges from 0.1% to 3.5%.²

There are 2 types of contact dermatitis: irritant and allergic. Irritant contact dermatitis results from an irritating or relatively caustic substance causing direct damage and inflammation to the skin. In allergic contact dermatitis, as occurred here, there is sensitization to a substance that causes a type IV delayed cell-mediated immune response. Although radioallergosorbent blood testing will usually show immunoglobulin E antibodies to the inciting substance, patch testing is more specific and will show a reaction to the imputed substance on direct skin application. This usually is performed as a panel of antigens tested at the same time.

The mainstay of treatment is to identify, stop use of, and then avoid the sensitizing substance. Topical steroids (triamcinolone 0.1% ointment or clobetasol 0.05% ointment twice daily) are helpful in most cases. If the condition is severe or does not respond to initial therapy, systemic steroids (prednisone 40 mg/d for 5 days for most cases or a 2- to 3-week taper for Rhus dermatitis [eg, poison ivy]) are often effective.³

This patient was instructed to stop using TTO and counseled to avoid it in the future. She was told that her nails might fall off due to the inflammation, which might cure her onychomycosis, and that it takes 12 to 18 months to grow new toenails. She was advised to return for evaluation if the new nails developed any abnormalities or if her onychomycosis recurred. Oral terbinafine 250 mg/d for 90 days is usually a safe and effective therapy.

‌

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

The patient’s toenail thickening appeared consistent with possible onychomycosis—but in addition, there was a marked inflammatory and vesicular eruption consistent with an allergic contact dermatitis.

TTO, also known as melaleuca oil, is a popular product used to treat many disorders including alopecia, seborrheic dermatitis, and onychomycosis.¹ Unfortunately, it is a complex compound, and the rate of positive reactions to patch testing ranges from 0.1% to 3.5%.²

There are 2 types of contact dermatitis: irritant and allergic. Irritant contact dermatitis results from an irritating or relatively caustic substance causing direct damage and inflammation to the skin. In allergic contact dermatitis, as occurred here, there is sensitization to a substance that causes a type IV delayed cell-mediated immune response. Although radioallergosorbent blood testing will usually show immunoglobulin E antibodies to the inciting substance, patch testing is more specific and will show a reaction to the imputed substance on direct skin application. This usually is performed as a panel of antigens tested at the same time.

The mainstay of treatment is to identify, stop use of, and then avoid the sensitizing substance. Topical steroids (triamcinolone 0.1% ointment or clobetasol 0.05% ointment twice daily) are helpful in most cases. If the condition is severe or does not respond to initial therapy, systemic steroids (prednisone 40 mg/d for 5 days for most cases or a 2- to 3-week taper for Rhus dermatitis [eg, poison ivy]) are often effective.³

This patient was instructed to stop using TTO and counseled to avoid it in the future. She was told that her nails might fall off due to the inflammation, which might cure her onychomycosis, and that it takes 12 to 18 months to grow new toenails. She was advised to return for evaluation if the new nails developed any abnormalities or if her onychomycosis recurred. Oral terbinafine 250 mg/d for 90 days is usually a safe and effective therapy.

‌

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

The patient’s toenail thickening appeared consistent with possible onychomycosis—but in addition, there was a marked inflammatory and vesicular eruption consistent with an allergic contact dermatitis.

TTO, also known as melaleuca oil, is a popular product used to treat many disorders including alopecia, seborrheic dermatitis, and onychomycosis.¹ Unfortunately, it is a complex compound, and the rate of positive reactions to patch testing ranges from 0.1% to 3.5%.²

There are 2 types of contact dermatitis: irritant and allergic. Irritant contact dermatitis results from an irritating or relatively caustic substance causing direct damage and inflammation to the skin. In allergic contact dermatitis, as occurred here, there is sensitization to a substance that causes a type IV delayed cell-mediated immune response. Although radioallergosorbent blood testing will usually show immunoglobulin E antibodies to the inciting substance, patch testing is more specific and will show a reaction to the imputed substance on direct skin application. This usually is performed as a panel of antigens tested at the same time.

The mainstay of treatment is to identify, stop use of, and then avoid the sensitizing substance. Topical steroids (triamcinolone 0.1% ointment or clobetasol 0.05% ointment twice daily) are helpful in most cases. If the condition is severe or does not respond to initial therapy, systemic steroids (prednisone 40 mg/d for 5 days for most cases or a 2- to 3-week taper for Rhus dermatitis [eg, poison ivy]) are often effective.³

This patient was instructed to stop using TTO and counseled to avoid it in the future. She was told that her nails might fall off due to the inflammation, which might cure her onychomycosis, and that it takes 12 to 18 months to grow new toenails. She was advised to return for evaluation if the new nails developed any abnormalities or if her onychomycosis recurred. Oral terbinafine 250 mg/d for 90 days is usually a safe and effective therapy.

‌

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

Optimism about new opportunities to treat alopecia areata can be derived not only from a recently approved Janus kinase (JAK) inhibitor in older children but promising results with the monoclonal antibody dupilumab alone or in combination with additional treatments, such as minoxidil or corticosteroids, in children with AA and concomitant atopy.

It was only a little over a year ago that the JAK inhibitor baricitinib became the first systemic therapy approved by the Food and Drug Administration for AA in adults. In June 2023, the JAK inhibitor ritlecitinib was approved for severe AA in patients as young as 12 years of age, but there is accumulating evidence that dupilumab, which binds to the interleukin-4 receptor, might be an option for even younger children with AA.

Of those who have worked with dupilumab for controlling AA in children, Brittany Craiglow, MD, an adjunct associate professor of dermatology at Yale University, New Haven, Conn., updated a case series at the recent MedscapeLive! Annual Women’s and Pediatric Dermatology Seminar in Baltimore. A series of six children with AA treated with dupilumab was published 2 years ago in JAAD Case Reports.

Even in 2021, her case series was not the first report of benefit from dupilumab in children with AA, but instead contributed to a “growing body of literature” supporting the potential benefit in the setting of concomitant atopy, Dr. Craiglow, one of the authors of the series, said in an interview.

Of the six patients in that series, five had improvement and four had complete regrowth with dupilumab, whether as a monotherapy or in combination with other agents. The children ranged in age from 7 to 12 years. The age range at the time of AA onset was 3-11 years. All had atopic dermatitis (AD) and most had additional atopic conditions, such as food allergies or asthma.

Since publication, Dr. Craiglow has successfully treated many more patients with dupilumab, either as monotherapy or in combination with oral minoxidil, corticosteroids, and/or a topical JAK inhibitor. Dupilumab, which is approved for the treatment of AD in children as young as 6 months of age, has been well tolerated.

“Oral minoxidil is often a great adjuvant treatment in patients with AA and should be used unless there are contraindications,” based on the initial and subsequent experience treating AA with dupilumab, said Dr. Craiglow.

“Topical steroids can be used in combination with dupilumab and minoxidil, but in general dupilumab should not be combined with an oral JAK inhibitor,” she added.

Now, with the approval of ritlecitinib, Dr. Craiglow said this JAK inhibitor will become a first-line therapy in children 12 years or older with severe, persistent AA, but she considers a trial of dupilumab reasonable in younger children, given the controlled studies of safety for atopic diseases.

“I would say that dupilumab could be considered in the following clinical scenarios: children under 12 with AA and concomitant atopy, such as atopic dermatitis, asthma, allergies, and/or elevated IgE; and children over the age of 12 with concomitant atopy who either have a contraindication to a JAK inhibitor or whose families have reservations about or are unwilling to take one,” Dr. Craiglow said.

In older children, she believes that dupilumab has “a much lower chance of being effective” than an oral JAK inhibitor like ritlecitinib, but it circumvents the potential safety issues of JAK inhibitors that have been observed in adults.

With ritlecitinib providing an on-label option for AA in older children, Dr. Craiglow suggested it might be easier to obtain third-party coverage for dupilumab as an alternative to a JAK inhibitor for AA in patients younger than 12, particularly when there is an indication for a concomitant atopic condition and a rationale, such as a concern about relative safety.

Two years ago, when Dr. Craiglow and her coinvestigator published their six-patient case series, a second case series was published about the same time by investigators at the University of Pennsylvania, Philadelphia, in the Journal of the American Academy of Dermatology. This series of 16 pediatric patients with AA on dupilumab was more heterogeneous, but four of six patients with active disease and more than 4 months of follow-up had improvement in AA, including total regrowth. The improvement was concentrated in patients with moderate to severe AD at the time of treatment.

Based on this series, the authors, led by Leslie Castelo-Soccio, MD, PhD, who is now an attending physician in the Dermatology Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md., concluded that dupilumab “may be a therapeutic option for AA” when traditional therapies have failed, “especially in patients with concurrent AD or asthma, for which the benefits of dupilumab are clear.”

When contacted about where this therapy might fit on the basis of her case series and the update on Dr. Craiglow’s experience, Dr. Castelo-Soccio, like Dr. Craiglow, stressed the importance of employing this therapy selectively.

“I do think that dupilumab is a reasonable option for AA in children with atopy and IgE levels greater than 200 IU/mL, especially if treatment is for atopic dermatitis or asthma as well,” she said.

Many clinicians, including Dr. Craiglow, have experience with oral JAK inhibitors in children younger than 12. Indeed, a recently published case study associated oral abrocitinib, a JAK inhibitor approved for moderate to severe AD in patients ages 12 and older, with hair regrowth in an 11-year-old child who had persistent AA for more than 6 years despite numerous conventional therapies.

However, the advantage of dupilumab in younger children is the greater evidence of safety, providing a level of reassurance for a treatment that is commonly used for severe atopic diseases but does not have a specific indication for AA, according to Dr. Craiglow.

Dr. Craiglow disclosed being a speaker for AbbVie and a speaker and consultant for Eli Lilly, Incyte, Pfizer, Regeneron, and Sanofi Genzyme. Dr. Castelo-Soccio had no disclosures.

Optimism about new opportunities to treat alopecia areata can be derived not only from a recently approved Janus kinase (JAK) inhibitor in older children but promising results with the monoclonal antibody dupilumab alone or in combination with additional treatments, such as minoxidil or corticosteroids, in children with AA and concomitant atopy.

It was only a little over a year ago that the JAK inhibitor baricitinib became the first systemic therapy approved by the Food and Drug Administration for AA in adults. In June 2023, the JAK inhibitor ritlecitinib was approved for severe AA in patients as young as 12 years of age, but there is accumulating evidence that dupilumab, which binds to the interleukin-4 receptor, might be an option for even younger children with AA.

Of those who have worked with dupilumab for controlling AA in children, Brittany Craiglow, MD, an adjunct associate professor of dermatology at Yale University, New Haven, Conn., updated a case series at the recent MedscapeLive! Annual Women’s and Pediatric Dermatology Seminar in Baltimore. A series of six children with AA treated with dupilumab was published 2 years ago in JAAD Case Reports.

Even in 2021, her case series was not the first report of benefit from dupilumab in children with AA, but instead contributed to a “growing body of literature” supporting the potential benefit in the setting of concomitant atopy, Dr. Craiglow, one of the authors of the series, said in an interview.

Of the six patients in that series, five had improvement and four had complete regrowth with dupilumab, whether as a monotherapy or in combination with other agents. The children ranged in age from 7 to 12 years. The age range at the time of AA onset was 3-11 years. All had atopic dermatitis (AD) and most had additional atopic conditions, such as food allergies or asthma.

Since publication, Dr. Craiglow has successfully treated many more patients with dupilumab, either as monotherapy or in combination with oral minoxidil, corticosteroids, and/or a topical JAK inhibitor. Dupilumab, which is approved for the treatment of AD in children as young as 6 months of age, has been well tolerated.

“Oral minoxidil is often a great adjuvant treatment in patients with AA and should be used unless there are contraindications,” based on the initial and subsequent experience treating AA with dupilumab, said Dr. Craiglow.

“Topical steroids can be used in combination with dupilumab and minoxidil, but in general dupilumab should not be combined with an oral JAK inhibitor,” she added.

Now, with the approval of ritlecitinib, Dr. Craiglow said this JAK inhibitor will become a first-line therapy in children 12 years or older with severe, persistent AA, but she considers a trial of dupilumab reasonable in younger children, given the controlled studies of safety for atopic diseases.

“I would say that dupilumab could be considered in the following clinical scenarios: children under 12 with AA and concomitant atopy, such as atopic dermatitis, asthma, allergies, and/or elevated IgE; and children over the age of 12 with concomitant atopy who either have a contraindication to a JAK inhibitor or whose families have reservations about or are unwilling to take one,” Dr. Craiglow said.

In older children, she believes that dupilumab has “a much lower chance of being effective” than an oral JAK inhibitor like ritlecitinib, but it circumvents the potential safety issues of JAK inhibitors that have been observed in adults.

With ritlecitinib providing an on-label option for AA in older children, Dr. Craiglow suggested it might be easier to obtain third-party coverage for dupilumab as an alternative to a JAK inhibitor for AA in patients younger than 12, particularly when there is an indication for a concomitant atopic condition and a rationale, such as a concern about relative safety.

Two years ago, when Dr. Craiglow and her coinvestigator published their six-patient case series, a second case series was published about the same time by investigators at the University of Pennsylvania, Philadelphia, in the Journal of the American Academy of Dermatology. This series of 16 pediatric patients with AA on dupilumab was more heterogeneous, but four of six patients with active disease and more than 4 months of follow-up had improvement in AA, including total regrowth. The improvement was concentrated in patients with moderate to severe AD at the time of treatment.

Based on this series, the authors, led by Leslie Castelo-Soccio, MD, PhD, who is now an attending physician in the Dermatology Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md., concluded that dupilumab “may be a therapeutic option for AA” when traditional therapies have failed, “especially in patients with concurrent AD or asthma, for which the benefits of dupilumab are clear.”

When contacted about where this therapy might fit on the basis of her case series and the update on Dr. Craiglow’s experience, Dr. Castelo-Soccio, like Dr. Craiglow, stressed the importance of employing this therapy selectively.

“I do think that dupilumab is a reasonable option for AA in children with atopy and IgE levels greater than 200 IU/mL, especially if treatment is for atopic dermatitis or asthma as well,” she said.

Many clinicians, including Dr. Craiglow, have experience with oral JAK inhibitors in children younger than 12. Indeed, a recently published case study associated oral abrocitinib, a JAK inhibitor approved for moderate to severe AD in patients ages 12 and older, with hair regrowth in an 11-year-old child who had persistent AA for more than 6 years despite numerous conventional therapies.

However, the advantage of dupilumab in younger children is the greater evidence of safety, providing a level of reassurance for a treatment that is commonly used for severe atopic diseases but does not have a specific indication for AA, according to Dr. Craiglow.

Dr. Craiglow disclosed being a speaker for AbbVie and a speaker and consultant for Eli Lilly, Incyte, Pfizer, Regeneron, and Sanofi Genzyme. Dr. Castelo-Soccio had no disclosures.

Optimism about new opportunities to treat alopecia areata can be derived not only from a recently approved Janus kinase (JAK) inhibitor in older children but promising results with the monoclonal antibody dupilumab alone or in combination with additional treatments, such as minoxidil or corticosteroids, in children with AA and concomitant atopy.

It was only a little over a year ago that the JAK inhibitor baricitinib became the first systemic therapy approved by the Food and Drug Administration for AA in adults. In June 2023, the JAK inhibitor ritlecitinib was approved for severe AA in patients as young as 12 years of age, but there is accumulating evidence that dupilumab, which binds to the interleukin-4 receptor, might be an option for even younger children with AA.

Of those who have worked with dupilumab for controlling AA in children, Brittany Craiglow, MD, an adjunct associate professor of dermatology at Yale University, New Haven, Conn., updated a case series at the recent MedscapeLive! Annual Women’s and Pediatric Dermatology Seminar in Baltimore. A series of six children with AA treated with dupilumab was published 2 years ago in JAAD Case Reports.

Even in 2021, her case series was not the first report of benefit from dupilumab in children with AA, but instead contributed to a “growing body of literature” supporting the potential benefit in the setting of concomitant atopy, Dr. Craiglow, one of the authors of the series, said in an interview.

Of the six patients in that series, five had improvement and four had complete regrowth with dupilumab, whether as a monotherapy or in combination with other agents. The children ranged in age from 7 to 12 years. The age range at the time of AA onset was 3-11 years. All had atopic dermatitis (AD) and most had additional atopic conditions, such as food allergies or asthma.

Since publication, Dr. Craiglow has successfully treated many more patients with dupilumab, either as monotherapy or in combination with oral minoxidil, corticosteroids, and/or a topical JAK inhibitor. Dupilumab, which is approved for the treatment of AD in children as young as 6 months of age, has been well tolerated.

“Oral minoxidil is often a great adjuvant treatment in patients with AA and should be used unless there are contraindications,” based on the initial and subsequent experience treating AA with dupilumab, said Dr. Craiglow.

“Topical steroids can be used in combination with dupilumab and minoxidil, but in general dupilumab should not be combined with an oral JAK inhibitor,” she added.

Now, with the approval of ritlecitinib, Dr. Craiglow said this JAK inhibitor will become a first-line therapy in children 12 years or older with severe, persistent AA, but she considers a trial of dupilumab reasonable in younger children, given the controlled studies of safety for atopic diseases.

“I would say that dupilumab could be considered in the following clinical scenarios: children under 12 with AA and concomitant atopy, such as atopic dermatitis, asthma, allergies, and/or elevated IgE; and children over the age of 12 with concomitant atopy who either have a contraindication to a JAK inhibitor or whose families have reservations about or are unwilling to take one,” Dr. Craiglow said.

In older children, she believes that dupilumab has “a much lower chance of being effective” than an oral JAK inhibitor like ritlecitinib, but it circumvents the potential safety issues of JAK inhibitors that have been observed in adults.

With ritlecitinib providing an on-label option for AA in older children, Dr. Craiglow suggested it might be easier to obtain third-party coverage for dupilumab as an alternative to a JAK inhibitor for AA in patients younger than 12, particularly when there is an indication for a concomitant atopic condition and a rationale, such as a concern about relative safety.

Two years ago, when Dr. Craiglow and her coinvestigator published their six-patient case series, a second case series was published about the same time by investigators at the University of Pennsylvania, Philadelphia, in the Journal of the American Academy of Dermatology. This series of 16 pediatric patients with AA on dupilumab was more heterogeneous, but four of six patients with active disease and more than 4 months of follow-up had improvement in AA, including total regrowth. The improvement was concentrated in patients with moderate to severe AD at the time of treatment.

Based on this series, the authors, led by Leslie Castelo-Soccio, MD, PhD, who is now an attending physician in the Dermatology Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md., concluded that dupilumab “may be a therapeutic option for AA” when traditional therapies have failed, “especially in patients with concurrent AD or asthma, for which the benefits of dupilumab are clear.”

When contacted about where this therapy might fit on the basis of her case series and the update on Dr. Craiglow’s experience, Dr. Castelo-Soccio, like Dr. Craiglow, stressed the importance of employing this therapy selectively.

“I do think that dupilumab is a reasonable option for AA in children with atopy and IgE levels greater than 200 IU/mL, especially if treatment is for atopic dermatitis or asthma as well,” she said.

Many clinicians, including Dr. Craiglow, have experience with oral JAK inhibitors in children younger than 12. Indeed, a recently published case study associated oral abrocitinib, a JAK inhibitor approved for moderate to severe AD in patients ages 12 and older, with hair regrowth in an 11-year-old child who had persistent AA for more than 6 years despite numerous conventional therapies.

However, the advantage of dupilumab in younger children is the greater evidence of safety, providing a level of reassurance for a treatment that is commonly used for severe atopic diseases but does not have a specific indication for AA, according to Dr. Craiglow.

Dr. Craiglow disclosed being a speaker for AbbVie and a speaker and consultant for Eli Lilly, Incyte, Pfizer, Regeneron, and Sanofi Genzyme. Dr. Castelo-Soccio had no disclosures.

A new practice guideline is setting a standard for doctors who use lasers to treat cutaneous vascular anomalies.

Poor treatment has been an issue in this field because no uniform guidelines existed to inform practice, according to a press release from the American Society for Laser Medicine and Surgery.

The laser treatment settings can vary based on the type and location of the birthmark and also the patient’s skin type, which has resulted in an inconsistent approach from clinicians, according to the release.

“For decades, I have observed adverse outcomes from the improper laser treatment of vascular birthmarks,” Linda Rozell-Shannon, PhD, president and founder of the Vascular Birthmarks Foundation said in a statement from ASLMS. “As a result of these guidelines, patient outcomes will be improved.”

The guideline, published on the ASLMS website along with supporting videos, was jointly developed by ASLMS, VBF, and an international group of clinicians, marking the first consensus guideline on laser treatments for cutaneous vascular anomalies. It details 32 best practice directives for various scenarios, including advice on safety considerations, additional testing, and when to refer.

“It is important to realize that just because someone is board certified does not mean they are skilled in treating all conditions or using all lasers,” Paul Friedman, MD, a dermatologist in Houston, and former president of ASLMS, said in the ASLMS statement.

Vascular birthmarks are a common condition affecting up to 14% of children, according to VBF. Most are hemangiomas, a buildup of blood vessels that usually appears at birth or within a month after birth. Laser therapy reduces the size and color of the anomalies.

Support for this initiative was provided by Candela Medical.

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

A new practice guideline is setting a standard for doctors who use lasers to treat cutaneous vascular anomalies.

Poor treatment has been an issue in this field because no uniform guidelines existed to inform practice, according to a press release from the American Society for Laser Medicine and Surgery.

The laser treatment settings can vary based on the type and location of the birthmark and also the patient’s skin type, which has resulted in an inconsistent approach from clinicians, according to the release.

“For decades, I have observed adverse outcomes from the improper laser treatment of vascular birthmarks,” Linda Rozell-Shannon, PhD, president and founder of the Vascular Birthmarks Foundation said in a statement from ASLMS. “As a result of these guidelines, patient outcomes will be improved.”

The guideline, published on the ASLMS website along with supporting videos, was jointly developed by ASLMS, VBF, and an international group of clinicians, marking the first consensus guideline on laser treatments for cutaneous vascular anomalies. It details 32 best practice directives for various scenarios, including advice on safety considerations, additional testing, and when to refer.

“It is important to realize that just because someone is board certified does not mean they are skilled in treating all conditions or using all lasers,” Paul Friedman, MD, a dermatologist in Houston, and former president of ASLMS, said in the ASLMS statement.

Vascular birthmarks are a common condition affecting up to 14% of children, according to VBF. Most are hemangiomas, a buildup of blood vessels that usually appears at birth or within a month after birth. Laser therapy reduces the size and color of the anomalies.

Support for this initiative was provided by Candela Medical.

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

A new practice guideline is setting a standard for doctors who use lasers to treat cutaneous vascular anomalies.

Poor treatment has been an issue in this field because no uniform guidelines existed to inform practice, according to a press release from the American Society for Laser Medicine and Surgery.

The laser treatment settings can vary based on the type and location of the birthmark and also the patient’s skin type, which has resulted in an inconsistent approach from clinicians, according to the release.

“For decades, I have observed adverse outcomes from the improper laser treatment of vascular birthmarks,” Linda Rozell-Shannon, PhD, president and founder of the Vascular Birthmarks Foundation said in a statement from ASLMS. “As a result of these guidelines, patient outcomes will be improved.”

The guideline, published on the ASLMS website along with supporting videos, was jointly developed by ASLMS, VBF, and an international group of clinicians, marking the first consensus guideline on laser treatments for cutaneous vascular anomalies. It details 32 best practice directives for various scenarios, including advice on safety considerations, additional testing, and when to refer.

“It is important to realize that just because someone is board certified does not mean they are skilled in treating all conditions or using all lasers,” Paul Friedman, MD, a dermatologist in Houston, and former president of ASLMS, said in the ASLMS statement.

Vascular birthmarks are a common condition affecting up to 14% of children, according to VBF. Most are hemangiomas, a buildup of blood vessels that usually appears at birth or within a month after birth. Laser therapy reduces the size and color of the anomalies.

Support for this initiative was provided by Candela Medical.

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

ASHEVILLE, N.C. – Epidermolysis bullosa (EB), a heterogeneous congenital condition of skin fragility, received its first U.S. Food and Drug Association–approved gene therapy only a few months ago, but accelerated progress across multiple treatment strategies predicts additional important and perhaps dramatic further progress, according to a prominent EB researcher.

Not only are recent developments in EB “exciting,” the progress on multiple fronts for control of disease or its symptoms suggests “we are on the cusp of a new era,” Jemima Mellerio, BSc, MD, a consultant dermatologist, St. John’s Institute of Dermatology, London, said at the annual meeting of the Society for Pediatric Dermatology.

Published clinical studies of cell therapies and gene therapies date back at least 15 years, according to a review by Dr. Mellerio on why developments are starting to move so quickly. The difference now is that many obstacles to routine use of these options are being resolved so that viable strategies have reached or are reaching phase 3 trials.

In addition to cell therapies and gene therapies, Dr. Mellerio discussed progress in three additional areas: gene editing, protein therapy, and drug repurposing.

Summarizing progress in each, she described improvement in levels of collagen VII, an important deficit in most types of EB, that were achieved with fibroblast injections that improved levels of collagen VII and anchoring fibrils in a study published in the Journal of Investigative Dermatology. Injection of mesenchymal stromal cells (MSC) have been associated with reduced pain and itch in a series of studies, one of the earliest of which was published in the New England Journal of Medicine.

Since that time, there have been several approaches using MSC.

Of these approaches, intravenous injection of ABCB5+ MSCs might be the first to gain regulatory approval. According to Dr. Mellerio, there is an ongoing phase 3 crossover trial evaluating this approach, which followed several earlier phase studies that demonstrated adequate safety and tolerability while reducing severity scores, relieving pain and itch, and improving wound closure in patients with EB.

In 2006, correction of junctional EB (JEB) was achieved by transplantation of genetically modified epidermal cells to replace the LAMB3 gene, thereby restoring production of laminin 332, which is an essential component of the dermal-epidermal junction, according to Dr. Mellerio, citing a study in Nature Medicine.

The next attempt with this approach did not take place until 2015, resurrected to save the life of a 7-year-old Syrian boy – to generate epidermal sheets that eventually covered 80% of his body. The success is supporting further work on this approach but has also been an inspiration to other gene therapies, including a topical gene therapy recently approved in the United States.

Topically applied beremagene geperpavec (Vyjuvek, formerly known as B-VEC) was approved by the FDA in May for treating wounds in patients 6 months of age and older, with recessive or dominant dystrophic EB, on the basis of a phase 3 trial published in the New England Journal of Medicine, but others are coming. Dr. Mellerio also described a recently completed phase 3 trial with introduction of ex vivo gene-corrected keratinocytes, which has been associated with long-term improvements among patients with recessive dystrophic EB (RDEB). The responses in early phase studies included wound healing and reduction in pain and itch.

Perhaps less advanced but still promising, protein therapy, gene editing, and repurposing of existing therapies are all approaches that are moving forward. Many are supported by at least some clinical data, according to Dr. Mellerio.

As an example of protein therapy, a completed phase I/II trial associated recombinant human collagen with wound healing and pain reduction in RDEB. This study provided proof of principle for a therapy that could be applied topically or intravenously. Further development is anticipated.

Multiple platforms for gene editing have been described with the goal of simply excising pathogenic mutations or antisense oligonucleotides for sustained or permanent control of EB expression. Clinical evidence is limited, but Dr. Mellerio suggested that the theoretical potential for eliminating the source of abnormal transcription is the restoration of functional proteins essential for reversing skin fragility.

In some cases, existing drugs have the same potential. Dr. Mellerio described efforts to use an aminoglycoside to circumvent nonsense mutations that produce messenger RNA decay and impaired production of the proteins that prevent EB. In a pilot study evaluating topical gentamicin in RDEB, there were substantial improvements at 1 month and 3 months in several measures of skin fragility and encouraged studies that are now ongoing in both RDEB and JEB.

More than promising, a multinational randomized phase 3 study with birch bark extract recently published in the British Journal of Dermatology, associated treatment with this topical gel, known as Oleogel-S10, with higher rates of complete wound closure at 45 days (41.3% vs. 28.9% in the control vehicle arm) and a low risk of adverse events.

“This therapy is now approved in Europe and the United Kingdom, although, unfortunately, it is not yet available in the United States,” Dr. Mellerio noted.

Importantly, none of these therapies are necessarily effective across subtypes of EB, which often have different underlying pathogenic mechanisms, she said. However, the growing sophistication with which the pathophysiology of these subtypes is understood makes the numerous treatments in the pipeline “exciting.”

“We are at a point where we can really start to think of personalized medicine in EB,” Dr. Mellerio said. With the clinical advances already available and those expected, she suggested the recently approved treatment options are just the beginning. She expects the treatment landscape to evolve quickly over the next few years.

This does not appear to be a personal opinion. Another prominent researcher in EB, M. Peter Marinkovich, MD, director of the Stanford Bullous Disease and Psoriasis Clinics at Stanford (Calif.) University, is seeing the same real-world promise of therapies that have been in gestation for a decade or more.

“Dr. Mellerio is right. This is an exciting time for EB patients,” Dr. Marinkovich said in an interview. While the approval of B-VEC, the first gene therapy for EB, is the proof, Dr. Marinkovich, the lead author of the NEJM paper on B-VEC, noted that “many other potential EB therapies are being studied right now.” Based on promise in earlier clinical studies with many of these agents, he, like Dr. Mellerio, expects progress in real-world treatments for EB to accelerate.

Dr. Mellerio reported financial relationships with Amryt Pharma and Krystal Biotech. Dr. Marinkovich receives research support from Abeona Therapeutics, Castle Creek Pharmaceuticals, Krystal Biotech, Phoenix Tissue Repair, and WINGS Therapeutics.

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

ASHEVILLE, N.C. – Epidermolysis bullosa (EB), a heterogeneous congenital condition of skin fragility, received its first U.S. Food and Drug Association–approved gene therapy only a few months ago, but accelerated progress across multiple treatment strategies predicts additional important and perhaps dramatic further progress, according to a prominent EB researcher.

Not only are recent developments in EB “exciting,” the progress on multiple fronts for control of disease or its symptoms suggests “we are on the cusp of a new era,” Jemima Mellerio, BSc, MD, a consultant dermatologist, St. John’s Institute of Dermatology, London, said at the annual meeting of the Society for Pediatric Dermatology.

Published clinical studies of cell therapies and gene therapies date back at least 15 years, according to a review by Dr. Mellerio on why developments are starting to move so quickly. The difference now is that many obstacles to routine use of these options are being resolved so that viable strategies have reached or are reaching phase 3 trials.

In addition to cell therapies and gene therapies, Dr. Mellerio discussed progress in three additional areas: gene editing, protein therapy, and drug repurposing.

Summarizing progress in each, she described improvement in levels of collagen VII, an important deficit in most types of EB, that were achieved with fibroblast injections that improved levels of collagen VII and anchoring fibrils in a study published in the Journal of Investigative Dermatology. Injection of mesenchymal stromal cells (MSC) have been associated with reduced pain and itch in a series of studies, one of the earliest of which was published in the New England Journal of Medicine.

Since that time, there have been several approaches using MSC.

Of these approaches, intravenous injection of ABCB5+ MSCs might be the first to gain regulatory approval. According to Dr. Mellerio, there is an ongoing phase 3 crossover trial evaluating this approach, which followed several earlier phase studies that demonstrated adequate safety and tolerability while reducing severity scores, relieving pain and itch, and improving wound closure in patients with EB.

In 2006, correction of junctional EB (JEB) was achieved by transplantation of genetically modified epidermal cells to replace the LAMB3 gene, thereby restoring production of laminin 332, which is an essential component of the dermal-epidermal junction, according to Dr. Mellerio, citing a study in Nature Medicine.

The next attempt with this approach did not take place until 2015, resurrected to save the life of a 7-year-old Syrian boy – to generate epidermal sheets that eventually covered 80% of his body. The success is supporting further work on this approach but has also been an inspiration to other gene therapies, including a topical gene therapy recently approved in the United States.

Topically applied beremagene geperpavec (Vyjuvek, formerly known as B-VEC) was approved by the FDA in May for treating wounds in patients 6 months of age and older, with recessive or dominant dystrophic EB, on the basis of a phase 3 trial published in the New England Journal of Medicine, but others are coming. Dr. Mellerio also described a recently completed phase 3 trial with introduction of ex vivo gene-corrected keratinocytes, which has been associated with long-term improvements among patients with recessive dystrophic EB (RDEB). The responses in early phase studies included wound healing and reduction in pain and itch.

Perhaps less advanced but still promising, protein therapy, gene editing, and repurposing of existing therapies are all approaches that are moving forward. Many are supported by at least some clinical data, according to Dr. Mellerio.

As an example of protein therapy, a completed phase I/II trial associated recombinant human collagen with wound healing and pain reduction in RDEB. This study provided proof of principle for a therapy that could be applied topically or intravenously. Further development is anticipated.

Multiple platforms for gene editing have been described with the goal of simply excising pathogenic mutations or antisense oligonucleotides for sustained or permanent control of EB expression. Clinical evidence is limited, but Dr. Mellerio suggested that the theoretical potential for eliminating the source of abnormal transcription is the restoration of functional proteins essential for reversing skin fragility.

In some cases, existing drugs have the same potential. Dr. Mellerio described efforts to use an aminoglycoside to circumvent nonsense mutations that produce messenger RNA decay and impaired production of the proteins that prevent EB. In a pilot study evaluating topical gentamicin in RDEB, there were substantial improvements at 1 month and 3 months in several measures of skin fragility and encouraged studies that are now ongoing in both RDEB and JEB.

More than promising, a multinational randomized phase 3 study with birch bark extract recently published in the British Journal of Dermatology, associated treatment with this topical gel, known as Oleogel-S10, with higher rates of complete wound closure at 45 days (41.3% vs. 28.9% in the control vehicle arm) and a low risk of adverse events.

“This therapy is now approved in Europe and the United Kingdom, although, unfortunately, it is not yet available in the United States,” Dr. Mellerio noted.

Importantly, none of these therapies are necessarily effective across subtypes of EB, which often have different underlying pathogenic mechanisms, she said. However, the growing sophistication with which the pathophysiology of these subtypes is understood makes the numerous treatments in the pipeline “exciting.”

“We are at a point where we can really start to think of personalized medicine in EB,” Dr. Mellerio said. With the clinical advances already available and those expected, she suggested the recently approved treatment options are just the beginning. She expects the treatment landscape to evolve quickly over the next few years.

This does not appear to be a personal opinion. Another prominent researcher in EB, M. Peter Marinkovich, MD, director of the Stanford Bullous Disease and Psoriasis Clinics at Stanford (Calif.) University, is seeing the same real-world promise of therapies that have been in gestation for a decade or more.

“Dr. Mellerio is right. This is an exciting time for EB patients,” Dr. Marinkovich said in an interview. While the approval of B-VEC, the first gene therapy for EB, is the proof, Dr. Marinkovich, the lead author of the NEJM paper on B-VEC, noted that “many other potential EB therapies are being studied right now.” Based on promise in earlier clinical studies with many of these agents, he, like Dr. Mellerio, expects progress in real-world treatments for EB to accelerate.

Dr. Mellerio reported financial relationships with Amryt Pharma and Krystal Biotech. Dr. Marinkovich receives research support from Abeona Therapeutics, Castle Creek Pharmaceuticals, Krystal Biotech, Phoenix Tissue Repair, and WINGS Therapeutics.

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

ASHEVILLE, N.C. – Epidermolysis bullosa (EB), a heterogeneous congenital condition of skin fragility, received its first U.S. Food and Drug Association–approved gene therapy only a few months ago, but accelerated progress across multiple treatment strategies predicts additional important and perhaps dramatic further progress, according to a prominent EB researcher.

Not only are recent developments in EB “exciting,” the progress on multiple fronts for control of disease or its symptoms suggests “we are on the cusp of a new era,” Jemima Mellerio, BSc, MD, a consultant dermatologist, St. John’s Institute of Dermatology, London, said at the annual meeting of the Society for Pediatric Dermatology.

Published clinical studies of cell therapies and gene therapies date back at least 15 years, according to a review by Dr. Mellerio on why developments are starting to move so quickly. The difference now is that many obstacles to routine use of these options are being resolved so that viable strategies have reached or are reaching phase 3 trials.

In addition to cell therapies and gene therapies, Dr. Mellerio discussed progress in three additional areas: gene editing, protein therapy, and drug repurposing.

Summarizing progress in each, she described improvement in levels of collagen VII, an important deficit in most types of EB, that were achieved with fibroblast injections that improved levels of collagen VII and anchoring fibrils in a study published in the Journal of Investigative Dermatology. Injection of mesenchymal stromal cells (MSC) have been associated with reduced pain and itch in a series of studies, one of the earliest of which was published in the New England Journal of Medicine.

Since that time, there have been several approaches using MSC.

Of these approaches, intravenous injection of ABCB5+ MSCs might be the first to gain regulatory approval. According to Dr. Mellerio, there is an ongoing phase 3 crossover trial evaluating this approach, which followed several earlier phase studies that demonstrated adequate safety and tolerability while reducing severity scores, relieving pain and itch, and improving wound closure in patients with EB.

In 2006, correction of junctional EB (JEB) was achieved by transplantation of genetically modified epidermal cells to replace the LAMB3 gene, thereby restoring production of laminin 332, which is an essential component of the dermal-epidermal junction, according to Dr. Mellerio, citing a study in Nature Medicine.

The next attempt with this approach did not take place until 2015, resurrected to save the life of a 7-year-old Syrian boy – to generate epidermal sheets that eventually covered 80% of his body. The success is supporting further work on this approach but has also been an inspiration to other gene therapies, including a topical gene therapy recently approved in the United States.

Topically applied beremagene geperpavec (Vyjuvek, formerly known as B-VEC) was approved by the FDA in May for treating wounds in patients 6 months of age and older, with recessive or dominant dystrophic EB, on the basis of a phase 3 trial published in the New England Journal of Medicine, but others are coming. Dr. Mellerio also described a recently completed phase 3 trial with introduction of ex vivo gene-corrected keratinocytes, which has been associated with long-term improvements among patients with recessive dystrophic EB (RDEB). The responses in early phase studies included wound healing and reduction in pain and itch.

Perhaps less advanced but still promising, protein therapy, gene editing, and repurposing of existing therapies are all approaches that are moving forward. Many are supported by at least some clinical data, according to Dr. Mellerio.

As an example of protein therapy, a completed phase I/II trial associated recombinant human collagen with wound healing and pain reduction in RDEB. This study provided proof of principle for a therapy that could be applied topically or intravenously. Further development is anticipated.

Multiple platforms for gene editing have been described with the goal of simply excising pathogenic mutations or antisense oligonucleotides for sustained or permanent control of EB expression. Clinical evidence is limited, but Dr. Mellerio suggested that the theoretical potential for eliminating the source of abnormal transcription is the restoration of functional proteins essential for reversing skin fragility.

In some cases, existing drugs have the same potential. Dr. Mellerio described efforts to use an aminoglycoside to circumvent nonsense mutations that produce messenger RNA decay and impaired production of the proteins that prevent EB. In a pilot study evaluating topical gentamicin in RDEB, there were substantial improvements at 1 month and 3 months in several measures of skin fragility and encouraged studies that are now ongoing in both RDEB and JEB.

More than promising, a multinational randomized phase 3 study with birch bark extract recently published in the British Journal of Dermatology, associated treatment with this topical gel, known as Oleogel-S10, with higher rates of complete wound closure at 45 days (41.3% vs. 28.9% in the control vehicle arm) and a low risk of adverse events.

“This therapy is now approved in Europe and the United Kingdom, although, unfortunately, it is not yet available in the United States,” Dr. Mellerio noted.

Importantly, none of these therapies are necessarily effective across subtypes of EB, which often have different underlying pathogenic mechanisms, she said. However, the growing sophistication with which the pathophysiology of these subtypes is understood makes the numerous treatments in the pipeline “exciting.”

“We are at a point where we can really start to think of personalized medicine in EB,” Dr. Mellerio said. With the clinical advances already available and those expected, she suggested the recently approved treatment options are just the beginning. She expects the treatment landscape to evolve quickly over the next few years.

This does not appear to be a personal opinion. Another prominent researcher in EB, M. Peter Marinkovich, MD, director of the Stanford Bullous Disease and Psoriasis Clinics at Stanford (Calif.) University, is seeing the same real-world promise of therapies that have been in gestation for a decade or more.

“Dr. Mellerio is right. This is an exciting time for EB patients,” Dr. Marinkovich said in an interview. While the approval of B-VEC, the first gene therapy for EB, is the proof, Dr. Marinkovich, the lead author of the NEJM paper on B-VEC, noted that “many other potential EB therapies are being studied right now.” Based on promise in earlier clinical studies with many of these agents, he, like Dr. Mellerio, expects progress in real-world treatments for EB to accelerate.

Dr. Mellerio reported financial relationships with Amryt Pharma and Krystal Biotech. Dr. Marinkovich receives research support from Abeona Therapeutics, Castle Creek Pharmaceuticals, Krystal Biotech, Phoenix Tissue Repair, and WINGS Therapeutics.

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

Investigators have found a correlation between vitamin D deficiency and psoriasis severity, suggesting that some people who increase their intake of the vitamin could better control this skin condition that affects up to 8 million people in the United States alone. 

Brown University researchers studied almost 500 psoriasis cases taken from the National Health and Nutrition Examination Survey (NHANES), the scientists told attendees at the conference of the American Society for Nutrition. They compared the peoples’ reports on how much of their body surface was affected by psoriasis to vitamin D levels collected in blood samples.

“After adjusting for lifestyle factors such as smoking, the analysis showed that lower vitamin D levels and vitamin D deficiency were significantly associated with greater psoriasis severity,” the ASN said in a news release. “The researchers also found that patients with the least amount of body surface affected by psoriasis had the highest average vitamin D levels while those with the greatest affected area had the lowest average levels of vitamin D.”

The researchers said that people with psoriasis might improve their condition by getting more vitamin D in their diet and through supplements.

“Topical synthetic vitamin D creams are emerging as new therapies for psoriasis, but these usually require a doctor’s prescription,” said researcher Rachel K. Lim, an MD candidate at Brown University, Providence, R.I. “Our results suggest that a vitamin D–rich diet or oral vitamin D supplementation may also provide some benefit to psoriasis patients.”

The researchers said that vitamin D toxicity is rare but that people should consult with their medical caregivers before they start taking supplements.

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

Investigators have found a correlation between vitamin D deficiency and psoriasis severity, suggesting that some people who increase their intake of the vitamin could better control this skin condition that affects up to 8 million people in the United States alone. 

Brown University researchers studied almost 500 psoriasis cases taken from the National Health and Nutrition Examination Survey (NHANES), the scientists told attendees at the conference of the American Society for Nutrition. They compared the peoples’ reports on how much of their body surface was affected by psoriasis to vitamin D levels collected in blood samples.

“After adjusting for lifestyle factors such as smoking, the analysis showed that lower vitamin D levels and vitamin D deficiency were significantly associated with greater psoriasis severity,” the ASN said in a news release. “The researchers also found that patients with the least amount of body surface affected by psoriasis had the highest average vitamin D levels while those with the greatest affected area had the lowest average levels of vitamin D.”

The researchers said that people with psoriasis might improve their condition by getting more vitamin D in their diet and through supplements.

“Topical synthetic vitamin D creams are emerging as new therapies for psoriasis, but these usually require a doctor’s prescription,” said researcher Rachel K. Lim, an MD candidate at Brown University, Providence, R.I. “Our results suggest that a vitamin D–rich diet or oral vitamin D supplementation may also provide some benefit to psoriasis patients.”

The researchers said that vitamin D toxicity is rare but that people should consult with their medical caregivers before they start taking supplements.

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

Investigators have found a correlation between vitamin D deficiency and psoriasis severity, suggesting that some people who increase their intake of the vitamin could better control this skin condition that affects up to 8 million people in the United States alone. 

Brown University researchers studied almost 500 psoriasis cases taken from the National Health and Nutrition Examination Survey (NHANES), the scientists told attendees at the conference of the American Society for Nutrition. They compared the peoples’ reports on how much of their body surface was affected by psoriasis to vitamin D levels collected in blood samples.

“After adjusting for lifestyle factors such as smoking, the analysis showed that lower vitamin D levels and vitamin D deficiency were significantly associated with greater psoriasis severity,” the ASN said in a news release. “The researchers also found that patients with the least amount of body surface affected by psoriasis had the highest average vitamin D levels while those with the greatest affected area had the lowest average levels of vitamin D.”

The researchers said that people with psoriasis might improve their condition by getting more vitamin D in their diet and through supplements.

“Topical synthetic vitamin D creams are emerging as new therapies for psoriasis, but these usually require a doctor’s prescription,” said researcher Rachel K. Lim, an MD candidate at Brown University, Providence, R.I. “Our results suggest that a vitamin D–rich diet or oral vitamin D supplementation may also provide some benefit to psoriasis patients.”

The researchers said that vitamin D toxicity is rare but that people should consult with their medical caregivers before they start taking supplements.

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