Dermatology

ORLANDO, FLORIDA — For some people, acne carries a one-two punch. First, they experience acne that is significant enough to decrease their quality of life, followed by scarring that can last a lifetime. For those patients, dermatologists have several options: Subcision to lift the depression of the scar, laser treatment to lower the height of scar tissue, and injections to fill scars.

“In my practice, I find that these [acne scars] are probably the hardest things to treat. But along the way, I created a protocol that I would love to share with you today,” Robyn Siperstein, MD, said at the annual ODAC Dermatology, Aesthetic & Surgical Conference.

Dr. Siperstein starts by identifying the type of acne scar — rolling scars, boxcar scars, or ice pick scars. Rolling scars tend to be shallower with no sharp edges; boxcar scars are deeper, more defined round or oval depressions; and ice pick scars, as the name suggests, look like someone stuck tiny ice picks into the skin, leaving a sunken or pitted appearance.

“It’s really important to categorize so that we know which ones are going to be effectively treated with different modalities and which ones aren’t, so that we can give our patients realistic expectations,” said Dr. Siperstein, a cosmetic dermatologist in private practice in Boca Raton, Florida, and a clinical affiliate associate professor of dermatology at Florida Atlantic University, Boca Raton.

“There’s not going to be one treatment that’s right for everything,” she said. Different approaches may be required even for the same patient because some people present with all three types of acne scars, she added.

Combining Treatments

When it comes to injecting dermal fillers into acne scars to lift the depressed areas, the US Food and Drug Administration approved a filler with polymethyl methacrylate filler and bovine collagen (Bellafill) for this indication (moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over age 21) in 2015. “And off-label, I use hyaluronic acid in my practice,” Dr. Siperstein said. Each filler “probably works a little bit better or differently on different types of scars.”

For rolling scars, she recommends hyaluronic acid (HA) dermal filler for everyone. “Of course, this is my opinion.” She was also a lead investigator in a randomized, placebo-controlled split-face study comparing HA filler with saline for correcting atrophic facial scars in 15 patients. The HA filler emerged superior, although there were some improvements with saline.

In her clinical experience, patients are happy with the results and ask, “Why didn’t the last four doctors do this?”

Boxcar scars are more challenging to fill with HA. In some cases, Dr. Siperstein is able to raise the depressed portion of the scar, but some of the vertical edges remain. In this scenario, she might combine treatments. Laser resurfacing, for example, might help convert boxcar scars into rolling scars, which then can be filled more successfully.

“Ice pick scars are tough,” Dr. Siperstein said. A punch removal technique can work in some cases, or she might try the “cross technique.” This involves placing acetic acid inside the scar using a Q-tip. “You have to be really careful,” she added, “because if you get it around the edges, it’s actually going to make the scar bigger.”
 

Choosing the Right Candidates

Selecting the right candidate for HA treatment of acne scars is essential. Dr. Siperstein shared the example of a lifeguard who had prominent acne scarring down the center of his chest. “He was embarrassed to go to the beach and take off his shirt. He said he felt like he had bullet holes in his chest.”

One month following treatment, “he had a really nice improvement, and now he feels really comfortable,” she said.

Some dermatologists might be reluctant to consider HA fillers for acne scarring because there is a misconception that HA is short-acting, lasting 6 months to 1 year before the effect wears off. That impression can persist from company-sponsored studies that limit follow-up to 6 months or 1 year “to get their drug to market,” she noted.

Also adding to this impression is that HA fillers in wrinkles may not last as long. Dr. Siperstein explained that wrinkles on the face are dynamic and constantly moving. In contrast, acne scars experience less movement, which helps the HA last longer. There is MRI evidence that shows HA fillers last over 2 years in the face, she added.

One tip to predict how well an acne scar might respond to filler injections is to squeeze it and look for the “dimple sign.” If the floor of the scar lifts up when squeezed, “we know that they’ll be a good candidate for hyaluronic acid filler.” Another tip is to inject HA in a retrograde technique high up in the skin. Inject tiny amounts — microdroplets — of the HA filler high on the dermis, she advised.

Deeper injections run the risk of raising the entire scar instead of filling it, she added.

Like many dermatologic procedures, before and after photos are essential to demonstrate improvements, Dr. Siperstein pointed out. Patients are often skeptical. “This happens a lot with acne scar patients. They’ve been to a million places that have promised results, they have not gotten them, and they are frustrated.”

Acne scars can result from picking, inflammation, or treatment. “This is what we see all day in clinic,” Dr. Siperstein said. “Somebody who had to undergo Accutane treatment but unfortunately is left with holes. This is a huge psychological burden on our patients,” she said, describing a younger patient who had scarring, which “led to depression — it was ruining his life.”

“His mom was willing to do whatever it took. And I said, You know what, I think filler will be enough,” Dr. Siperstein said. She counseled them that treatment would not make the scars disappear completely. But patients used to 10% improvements are very happy when their acne scars look 80% or 90% better, she added.

Dr. Siperstein received grant or research support and is a member of the speakers bureau for Allergan and Galderma. She is also a consultant/advisory board member for Allergan.
 

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — For some people, acne carries a one-two punch. First, they experience acne that is significant enough to decrease their quality of life, followed by scarring that can last a lifetime. For those patients, dermatologists have several options: Subcision to lift the depression of the scar, laser treatment to lower the height of scar tissue, and injections to fill scars.

“In my practice, I find that these [acne scars] are probably the hardest things to treat. But along the way, I created a protocol that I would love to share with you today,” Robyn Siperstein, MD, said at the annual ODAC Dermatology, Aesthetic & Surgical Conference.

Dr. Siperstein starts by identifying the type of acne scar — rolling scars, boxcar scars, or ice pick scars. Rolling scars tend to be shallower with no sharp edges; boxcar scars are deeper, more defined round or oval depressions; and ice pick scars, as the name suggests, look like someone stuck tiny ice picks into the skin, leaving a sunken or pitted appearance.

“It’s really important to categorize so that we know which ones are going to be effectively treated with different modalities and which ones aren’t, so that we can give our patients realistic expectations,” said Dr. Siperstein, a cosmetic dermatologist in private practice in Boca Raton, Florida, and a clinical affiliate associate professor of dermatology at Florida Atlantic University, Boca Raton.

“There’s not going to be one treatment that’s right for everything,” she said. Different approaches may be required even for the same patient because some people present with all three types of acne scars, she added.

Combining Treatments

When it comes to injecting dermal fillers into acne scars to lift the depressed areas, the US Food and Drug Administration approved a filler with polymethyl methacrylate filler and bovine collagen (Bellafill) for this indication (moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over age 21) in 2015. “And off-label, I use hyaluronic acid in my practice,” Dr. Siperstein said. Each filler “probably works a little bit better or differently on different types of scars.”

For rolling scars, she recommends hyaluronic acid (HA) dermal filler for everyone. “Of course, this is my opinion.” She was also a lead investigator in a randomized, placebo-controlled split-face study comparing HA filler with saline for correcting atrophic facial scars in 15 patients. The HA filler emerged superior, although there were some improvements with saline.

In her clinical experience, patients are happy with the results and ask, “Why didn’t the last four doctors do this?”

Boxcar scars are more challenging to fill with HA. In some cases, Dr. Siperstein is able to raise the depressed portion of the scar, but some of the vertical edges remain. In this scenario, she might combine treatments. Laser resurfacing, for example, might help convert boxcar scars into rolling scars, which then can be filled more successfully.

“Ice pick scars are tough,” Dr. Siperstein said. A punch removal technique can work in some cases, or she might try the “cross technique.” This involves placing acetic acid inside the scar using a Q-tip. “You have to be really careful,” she added, “because if you get it around the edges, it’s actually going to make the scar bigger.”
 

Choosing the Right Candidates

Selecting the right candidate for HA treatment of acne scars is essential. Dr. Siperstein shared the example of a lifeguard who had prominent acne scarring down the center of his chest. “He was embarrassed to go to the beach and take off his shirt. He said he felt like he had bullet holes in his chest.”

One month following treatment, “he had a really nice improvement, and now he feels really comfortable,” she said.

Some dermatologists might be reluctant to consider HA fillers for acne scarring because there is a misconception that HA is short-acting, lasting 6 months to 1 year before the effect wears off. That impression can persist from company-sponsored studies that limit follow-up to 6 months or 1 year “to get their drug to market,” she noted.

Also adding to this impression is that HA fillers in wrinkles may not last as long. Dr. Siperstein explained that wrinkles on the face are dynamic and constantly moving. In contrast, acne scars experience less movement, which helps the HA last longer. There is MRI evidence that shows HA fillers last over 2 years in the face, she added.

One tip to predict how well an acne scar might respond to filler injections is to squeeze it and look for the “dimple sign.” If the floor of the scar lifts up when squeezed, “we know that they’ll be a good candidate for hyaluronic acid filler.” Another tip is to inject HA in a retrograde technique high up in the skin. Inject tiny amounts — microdroplets — of the HA filler high on the dermis, she advised.

Deeper injections run the risk of raising the entire scar instead of filling it, she added.

Like many dermatologic procedures, before and after photos are essential to demonstrate improvements, Dr. Siperstein pointed out. Patients are often skeptical. “This happens a lot with acne scar patients. They’ve been to a million places that have promised results, they have not gotten them, and they are frustrated.”

Acne scars can result from picking, inflammation, or treatment. “This is what we see all day in clinic,” Dr. Siperstein said. “Somebody who had to undergo Accutane treatment but unfortunately is left with holes. This is a huge psychological burden on our patients,” she said, describing a younger patient who had scarring, which “led to depression — it was ruining his life.”

“His mom was willing to do whatever it took. And I said, You know what, I think filler will be enough,” Dr. Siperstein said. She counseled them that treatment would not make the scars disappear completely. But patients used to 10% improvements are very happy when their acne scars look 80% or 90% better, she added.

Dr. Siperstein received grant or research support and is a member of the speakers bureau for Allergan and Galderma. She is also a consultant/advisory board member for Allergan.
 

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — For some people, acne carries a one-two punch. First, they experience acne that is significant enough to decrease their quality of life, followed by scarring that can last a lifetime. For those patients, dermatologists have several options: Subcision to lift the depression of the scar, laser treatment to lower the height of scar tissue, and injections to fill scars.

“In my practice, I find that these [acne scars] are probably the hardest things to treat. But along the way, I created a protocol that I would love to share with you today,” Robyn Siperstein, MD, said at the annual ODAC Dermatology, Aesthetic & Surgical Conference.

Dr. Siperstein starts by identifying the type of acne scar — rolling scars, boxcar scars, or ice pick scars. Rolling scars tend to be shallower with no sharp edges; boxcar scars are deeper, more defined round or oval depressions; and ice pick scars, as the name suggests, look like someone stuck tiny ice picks into the skin, leaving a sunken or pitted appearance.

“It’s really important to categorize so that we know which ones are going to be effectively treated with different modalities and which ones aren’t, so that we can give our patients realistic expectations,” said Dr. Siperstein, a cosmetic dermatologist in private practice in Boca Raton, Florida, and a clinical affiliate associate professor of dermatology at Florida Atlantic University, Boca Raton.

“There’s not going to be one treatment that’s right for everything,” she said. Different approaches may be required even for the same patient because some people present with all three types of acne scars, she added.

Combining Treatments

When it comes to injecting dermal fillers into acne scars to lift the depressed areas, the US Food and Drug Administration approved a filler with polymethyl methacrylate filler and bovine collagen (Bellafill) for this indication (moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over age 21) in 2015. “And off-label, I use hyaluronic acid in my practice,” Dr. Siperstein said. Each filler “probably works a little bit better or differently on different types of scars.”

For rolling scars, she recommends hyaluronic acid (HA) dermal filler for everyone. “Of course, this is my opinion.” She was also a lead investigator in a randomized, placebo-controlled split-face study comparing HA filler with saline for correcting atrophic facial scars in 15 patients. The HA filler emerged superior, although there were some improvements with saline.

In her clinical experience, patients are happy with the results and ask, “Why didn’t the last four doctors do this?”

Boxcar scars are more challenging to fill with HA. In some cases, Dr. Siperstein is able to raise the depressed portion of the scar, but some of the vertical edges remain. In this scenario, she might combine treatments. Laser resurfacing, for example, might help convert boxcar scars into rolling scars, which then can be filled more successfully.

“Ice pick scars are tough,” Dr. Siperstein said. A punch removal technique can work in some cases, or she might try the “cross technique.” This involves placing acetic acid inside the scar using a Q-tip. “You have to be really careful,” she added, “because if you get it around the edges, it’s actually going to make the scar bigger.”
 

Choosing the Right Candidates

Selecting the right candidate for HA treatment of acne scars is essential. Dr. Siperstein shared the example of a lifeguard who had prominent acne scarring down the center of his chest. “He was embarrassed to go to the beach and take off his shirt. He said he felt like he had bullet holes in his chest.”

One month following treatment, “he had a really nice improvement, and now he feels really comfortable,” she said.

Some dermatologists might be reluctant to consider HA fillers for acne scarring because there is a misconception that HA is short-acting, lasting 6 months to 1 year before the effect wears off. That impression can persist from company-sponsored studies that limit follow-up to 6 months or 1 year “to get their drug to market,” she noted.

Also adding to this impression is that HA fillers in wrinkles may not last as long. Dr. Siperstein explained that wrinkles on the face are dynamic and constantly moving. In contrast, acne scars experience less movement, which helps the HA last longer. There is MRI evidence that shows HA fillers last over 2 years in the face, she added.

One tip to predict how well an acne scar might respond to filler injections is to squeeze it and look for the “dimple sign.” If the floor of the scar lifts up when squeezed, “we know that they’ll be a good candidate for hyaluronic acid filler.” Another tip is to inject HA in a retrograde technique high up in the skin. Inject tiny amounts — microdroplets — of the HA filler high on the dermis, she advised.

Deeper injections run the risk of raising the entire scar instead of filling it, she added.

Like many dermatologic procedures, before and after photos are essential to demonstrate improvements, Dr. Siperstein pointed out. Patients are often skeptical. “This happens a lot with acne scar patients. They’ve been to a million places that have promised results, they have not gotten them, and they are frustrated.”

Acne scars can result from picking, inflammation, or treatment. “This is what we see all day in clinic,” Dr. Siperstein said. “Somebody who had to undergo Accutane treatment but unfortunately is left with holes. This is a huge psychological burden on our patients,” she said, describing a younger patient who had scarring, which “led to depression — it was ruining his life.”

“His mom was willing to do whatever it took. And I said, You know what, I think filler will be enough,” Dr. Siperstein said. She counseled them that treatment would not make the scars disappear completely. But patients used to 10% improvements are very happy when their acne scars look 80% or 90% better, she added.

Dr. Siperstein received grant or research support and is a member of the speakers bureau for Allergan and Galderma. She is also a consultant/advisory board member for Allergan.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Melanoma in situ drives most cases of melanoma overdiagnoses, according to an analysis by Surveillance, Epidemiology, and End Results (SEER).

METHODOLOGY:

• The increase in melanoma diagnoses in the United States, while mortality has remained flat, has raised concerns about overdiagnosis of melanoma, cases that may not result in harm if left untreated. How much of the overdiagnoses can be attributed to melanoma in situ vs invasive melanoma is unknown.
• To address this question, researchers collected data from the SEER 9 registries database.
• They used DevCan software to calculate the cumulative lifetime risk of White American men and women being diagnosed with melanoma between 1975 and 2018, adjusting for changes in longevity and risk factors over the study period.
• The primary outcome was excess lifetime risk for melanoma diagnosis between 1976 and 2018, adjusted for year 2018 competing mortality and changes in risk factors.

TAKEAWAY:

• Researchers found that between 1975 and 2018, the adjusted lifetime risk of being diagnosed with melanoma in situ increased from 0.17% to 2.7% in White men and 0.08% to 2% in White women.
• An estimated 49.7% and 64.6% of melanomas diagnosed in White men and White women, respectively, were overdiagnosed in 2018.
• Among individuals diagnosed with melanoma in situ, 89.4% of White men and 85.4% of White women were likely overdiagnosed in 2018.

IN PRACTICE:

“A large proportion of overdiagnosed melanomas are in situ cancers, pointing to a potential area to focus for an intervention de-escalation of the intensity of treatment and survivorship care,” the authors wrote.

SOURCE:

Adewole S. Adamson, MD, of the Division of Dermatology at The University of Texas at Austin Dell Medical School, led the research. The study was published in BMJ Evidence-Based Medicine on January 19, 2024.

LIMITATIONS:

The analysis only involved White individuals. Other limitations include a high risk for selection bias and that the researchers assumed no melanoma diagnosis in 1975, which may not be the case.

DISCLOSURES:

Dr. Adamson disclosed that he is supported by the Robert Wood Johnson Foundation through The Harold Amos Medical Faculty Development Program. Coauthor Katy J.L. Bell, MBchB, PhD, of the University of Sydney, is supported by an Australian Government National Health and Medical Research Council Investigator Grant.

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

TOPLINE:

Melanoma in situ drives most cases of melanoma overdiagnoses, according to an analysis by Surveillance, Epidemiology, and End Results (SEER).

METHODOLOGY:

• The increase in melanoma diagnoses in the United States, while mortality has remained flat, has raised concerns about overdiagnosis of melanoma, cases that may not result in harm if left untreated. How much of the overdiagnoses can be attributed to melanoma in situ vs invasive melanoma is unknown.
• To address this question, researchers collected data from the SEER 9 registries database.
• They used DevCan software to calculate the cumulative lifetime risk of White American men and women being diagnosed with melanoma between 1975 and 2018, adjusting for changes in longevity and risk factors over the study period.
• The primary outcome was excess lifetime risk for melanoma diagnosis between 1976 and 2018, adjusted for year 2018 competing mortality and changes in risk factors.

TAKEAWAY:

• Researchers found that between 1975 and 2018, the adjusted lifetime risk of being diagnosed with melanoma in situ increased from 0.17% to 2.7% in White men and 0.08% to 2% in White women.
• An estimated 49.7% and 64.6% of melanomas diagnosed in White men and White women, respectively, were overdiagnosed in 2018.
• Among individuals diagnosed with melanoma in situ, 89.4% of White men and 85.4% of White women were likely overdiagnosed in 2018.

IN PRACTICE:

“A large proportion of overdiagnosed melanomas are in situ cancers, pointing to a potential area to focus for an intervention de-escalation of the intensity of treatment and survivorship care,” the authors wrote.

SOURCE:

Adewole S. Adamson, MD, of the Division of Dermatology at The University of Texas at Austin Dell Medical School, led the research. The study was published in BMJ Evidence-Based Medicine on January 19, 2024.

LIMITATIONS:

The analysis only involved White individuals. Other limitations include a high risk for selection bias and that the researchers assumed no melanoma diagnosis in 1975, which may not be the case.

DISCLOSURES:

Dr. Adamson disclosed that he is supported by the Robert Wood Johnson Foundation through The Harold Amos Medical Faculty Development Program. Coauthor Katy J.L. Bell, MBchB, PhD, of the University of Sydney, is supported by an Australian Government National Health and Medical Research Council Investigator Grant.

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

TOPLINE:

Melanoma in situ drives most cases of melanoma overdiagnoses, according to an analysis by Surveillance, Epidemiology, and End Results (SEER).

METHODOLOGY:

• The increase in melanoma diagnoses in the United States, while mortality has remained flat, has raised concerns about overdiagnosis of melanoma, cases that may not result in harm if left untreated. How much of the overdiagnoses can be attributed to melanoma in situ vs invasive melanoma is unknown.
• To address this question, researchers collected data from the SEER 9 registries database.
• They used DevCan software to calculate the cumulative lifetime risk of White American men and women being diagnosed with melanoma between 1975 and 2018, adjusting for changes in longevity and risk factors over the study period.
• The primary outcome was excess lifetime risk for melanoma diagnosis between 1976 and 2018, adjusted for year 2018 competing mortality and changes in risk factors.

TAKEAWAY:

• Researchers found that between 1975 and 2018, the adjusted lifetime risk of being diagnosed with melanoma in situ increased from 0.17% to 2.7% in White men and 0.08% to 2% in White women.
• An estimated 49.7% and 64.6% of melanomas diagnosed in White men and White women, respectively, were overdiagnosed in 2018.
• Among individuals diagnosed with melanoma in situ, 89.4% of White men and 85.4% of White women were likely overdiagnosed in 2018.

IN PRACTICE:

“A large proportion of overdiagnosed melanomas are in situ cancers, pointing to a potential area to focus for an intervention de-escalation of the intensity of treatment and survivorship care,” the authors wrote.

SOURCE:

Adewole S. Adamson, MD, of the Division of Dermatology at The University of Texas at Austin Dell Medical School, led the research. The study was published in BMJ Evidence-Based Medicine on January 19, 2024.

LIMITATIONS:

The analysis only involved White individuals. Other limitations include a high risk for selection bias and that the researchers assumed no melanoma diagnosis in 1975, which may not be the case.

DISCLOSURES:

Dr. Adamson disclosed that he is supported by the Robert Wood Johnson Foundation through The Harold Amos Medical Faculty Development Program. Coauthor Katy J.L. Bell, MBchB, PhD, of the University of Sydney, is supported by an Australian Government National Health and Medical Research Council Investigator Grant.

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

TOPLINE:

Patients with pemphigus who received rituximab as first-line therapy experienced sustained remission without corticosteroids or additional rituximab infusions, an analysis showed.

METHODOLOGY:

• The short-term efficacy and safety of first-line treatment with rituximab for pemphigus were demonstrated in the Ritux 3 trial, but the rates of long-term remission are unknown.
• French investigators from 25 dermatology departments evaluated 83 patients from the Ritux 3 trial between January 1, 2010, and December 31, 2015.
• They used Kaplan-Meir curves to determine the 5- and 7-year rates of disease-free survival (DFS) without corticosteroids.

TAKEAWAY:

• Of the 83 patients, 44 were in the rituximab-plus-prednisone group and 39 were in the prednisone-only group, with a median follow-up of 87.3 months (7.3 years).
• Among patients in the rituximab plus prednisone group, 43 (93.5%) achieved complete remission without corticosteroids at any time during follow-up, compared with 17 patients (39%) in the prednisone-only group.
• DFS (without corticosteroid therapy) statistically favored patients in the rituximab plus prednisone group compared with patients in the prednisone-only group at follow-up times of 5 years (76.7% vs 35.3%, respectively) and 7 years (72.1% vs 35.3%; P < .001 for both associations).
• In another finding, 31 patients in the rituximab plus prednisone group reported fewer serious adverse events (SAEs) than 58 patients in the prednisone-only group, which corresponds to 0.67 and 1.32 SAEs per patient, respectively (P = .003).

IN PRACTICE:

The study findings demonstrated “the superiority of rituximab over a standard corticosteroids regimen, both in the short term and the long term,” the authors wrote.

SOURCE:

Corresponding author Billal Tedbirt, MD, of the Department of Dermatology at CHU Rouen in France, led the study, which was published online on January 24, 2024, in JAMA Dermatology.

LIMITATIONS:

Nearly 8% of patients did not attend the end of follow-up visit. Also, serum samples used to predict relapse were drawn at month 36, but the researchers said that a window of every 4-6 months might provide higher accuracy of relapses.

DISCLOSURES:

Dr. Tedbirt reported having no disclosures. Four of the study authors reported being investigators for and/or receiving personal fees from several pharmaceutical companies. The study was supported by a grant from the French Society of Dermatology.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with pemphigus who received rituximab as first-line therapy experienced sustained remission without corticosteroids or additional rituximab infusions, an analysis showed.

METHODOLOGY:

• The short-term efficacy and safety of first-line treatment with rituximab for pemphigus were demonstrated in the Ritux 3 trial, but the rates of long-term remission are unknown.
• French investigators from 25 dermatology departments evaluated 83 patients from the Ritux 3 trial between January 1, 2010, and December 31, 2015.
• They used Kaplan-Meir curves to determine the 5- and 7-year rates of disease-free survival (DFS) without corticosteroids.

TAKEAWAY:

• Of the 83 patients, 44 were in the rituximab-plus-prednisone group and 39 were in the prednisone-only group, with a median follow-up of 87.3 months (7.3 years).
• Among patients in the rituximab plus prednisone group, 43 (93.5%) achieved complete remission without corticosteroids at any time during follow-up, compared with 17 patients (39%) in the prednisone-only group.
• DFS (without corticosteroid therapy) statistically favored patients in the rituximab plus prednisone group compared with patients in the prednisone-only group at follow-up times of 5 years (76.7% vs 35.3%, respectively) and 7 years (72.1% vs 35.3%; P < .001 for both associations).
• In another finding, 31 patients in the rituximab plus prednisone group reported fewer serious adverse events (SAEs) than 58 patients in the prednisone-only group, which corresponds to 0.67 and 1.32 SAEs per patient, respectively (P = .003).

IN PRACTICE:

The study findings demonstrated “the superiority of rituximab over a standard corticosteroids regimen, both in the short term and the long term,” the authors wrote.

SOURCE:

Corresponding author Billal Tedbirt, MD, of the Department of Dermatology at CHU Rouen in France, led the study, which was published online on January 24, 2024, in JAMA Dermatology.

LIMITATIONS:

Nearly 8% of patients did not attend the end of follow-up visit. Also, serum samples used to predict relapse were drawn at month 36, but the researchers said that a window of every 4-6 months might provide higher accuracy of relapses.

DISCLOSURES:

Dr. Tedbirt reported having no disclosures. Four of the study authors reported being investigators for and/or receiving personal fees from several pharmaceutical companies. The study was supported by a grant from the French Society of Dermatology.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with pemphigus who received rituximab as first-line therapy experienced sustained remission without corticosteroids or additional rituximab infusions, an analysis showed.

METHODOLOGY:

• The short-term efficacy and safety of first-line treatment with rituximab for pemphigus were demonstrated in the Ritux 3 trial, but the rates of long-term remission are unknown.
• French investigators from 25 dermatology departments evaluated 83 patients from the Ritux 3 trial between January 1, 2010, and December 31, 2015.
• They used Kaplan-Meir curves to determine the 5- and 7-year rates of disease-free survival (DFS) without corticosteroids.

TAKEAWAY:

• Of the 83 patients, 44 were in the rituximab-plus-prednisone group and 39 were in the prednisone-only group, with a median follow-up of 87.3 months (7.3 years).
• Among patients in the rituximab plus prednisone group, 43 (93.5%) achieved complete remission without corticosteroids at any time during follow-up, compared with 17 patients (39%) in the prednisone-only group.
• DFS (without corticosteroid therapy) statistically favored patients in the rituximab plus prednisone group compared with patients in the prednisone-only group at follow-up times of 5 years (76.7% vs 35.3%, respectively) and 7 years (72.1% vs 35.3%; P < .001 for both associations).
• In another finding, 31 patients in the rituximab plus prednisone group reported fewer serious adverse events (SAEs) than 58 patients in the prednisone-only group, which corresponds to 0.67 and 1.32 SAEs per patient, respectively (P = .003).

IN PRACTICE:

The study findings demonstrated “the superiority of rituximab over a standard corticosteroids regimen, both in the short term and the long term,” the authors wrote.

SOURCE:

Corresponding author Billal Tedbirt, MD, of the Department of Dermatology at CHU Rouen in France, led the study, which was published online on January 24, 2024, in JAMA Dermatology.

LIMITATIONS:

Nearly 8% of patients did not attend the end of follow-up visit. Also, serum samples used to predict relapse were drawn at month 36, but the researchers said that a window of every 4-6 months might provide higher accuracy of relapses.

DISCLOSURES:

Dr. Tedbirt reported having no disclosures. Four of the study authors reported being investigators for and/or receiving personal fees from several pharmaceutical companies. The study was supported by a grant from the French Society of Dermatology.

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — Advances in treating medical conditions rarely emerge in a straight line. Oftentimes, progress comes in fits and starts, and therapies to treat cutaneous lupus erythematosus (CLE) and dermatomyositis are no exception.

Beyond approved treatments that deserve more attention, like belimumab, approved by the Food and Drug Administration (FDA) for systemic lupus erythematosus (SLE) in 2011, and Octagam 10%, an intravenous immune globulin (IVIG) preparation approved for dermatomyositis in 2021, anticipation is growing for emerging therapies and their potential to provide relief to patients, Anthony Fernandez, MD, PhD, said at the ODAC Dermatology, Aesthetic & Surgical Conference. The tyrosine kinase 2 (TYK2) inhibitor deucravacitinib, Janus kinase (JAK) inhibitors brepocitinib and baricitinib, and the monoclonal antibody anifrolumab, he noted, are prime examples.

“There have been significant advances in the development of treatments for lupus erythematosus and dermatomyositis. In my opinion, this is the start of what will be the most exciting decade in the history of these two diseases,” said Dr. Fernandez, director of medical dermatology at the Cleveland Clinic.
 

Emerging Treatments for Cutaneous Lupus

Although SLE can involve many organ systems, the skin is one of the most affected. There are specific cutaneous lesions categorized as either acute cutaneous lupus, subacute cutaneous lupus, or chronic cutaneous lupus.

The oral TYK2 inhibitor deucravacitinib, for example, should be able to dampen interleukin responses in people with CLE, Dr. Fernandez said. Deucravacitinib was approved by the FDA to treat psoriasis in September 2022.

Cleveland Clinic Foundation

A phase 2 study published in 2023 focused on this agent for relief of systemic lupus. Improvements in cutaneous disease were a secondary endpoint. The trial demonstrated that the patients treated with deucravacitinib achieved a 56%-70% CLASI-50 response, depending on dosing, compared with a 17% response among those on placebo at week 48.

Based on the trial results, recruitment has begun for a phase 2 trial to evaluate deucravacitinib, compared with placebo, in patients with discoid and/or subacute cutaneous lupus. “This may be another medicine we have available to give to any of our patients with cutaneous lupus,” Dr. Fernandez said.
 

Anifrolumab Appears Promising

The FDA approval of anifrolumab, a type I interferon (IFN) receptor antagonist, for treating moderate to severe SLE in July 2021, for example, is good news for dermatologists and their patients, added Dr. Fernandez. “Almost immediately after approval, case studies showed marked improvement in patients with refractory cutaneous lupus.” While the therapy was approved for treating systemic lupus, it allows for off-label treatment of the cutaneous predominant form of the disease, he said.

Furthermore, the manufacturer of anifrolumab, AstraZeneca, is launching the LAVENDER clinical trial to assess the monoclonal antibody specifically for treating CLE. “This is a big deal because we may be able to prescribe anifrolumab for our cutaneous lupus patients who don’t have systemic lupus,” Dr. Fernandez said.

Phase 3 data supported use the of anifrolumab in systemic lupus, including the TULIP-2 trial, which demonstrated its superiority to placebo for reducing severity of systemic disease and lowering corticosteroid use. A study published in March 2023 of 11 patients showed that they had a “very fast response” to the agent, Dr. Fernandez said, with a 50% or greater improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score reached by all participants at week 16. Improvements of 50% or more in this scoring system are considered clinically meaningful, he added.
 

Upcoming Dermatomyositis Treatments

Why highlight emerging therapies for CLE and dermatomyositis in the same ODAC presentation? Although distinct conditions, these autoimmune conditions are both mediated by type 1 IFN inflammation.

Dermatomyositis is a relatively rare immune-mediated disease that most commonly affects the skin and muscle. Doctors score disease presentation, activity, and clinical improvements on a scale similar to CLASI for cutaneous lupus, the CDASI or Cutaneous Dermatomyositis Disease Area and Severity Index. Among people with CDASI activity scores of at least 14, which is the threshold for moderate to severe disease, a 20% improvement is clinically meaningful, Dr. Fernandez said. In addition, a 40% or greater improvement correlates with significant improvements in quality of life.

There is now more evidence for the use of IVIG to treat dermatomyositis. “Among those of us who treat dermatomyositis on a regular basis, we believe IVIG is the most potent treatment. We’ve known that for a long time,” Dr. Fernandez said.

Despite this tenet, for years, there was only one placebo-controlled trial, published in 1993, that evaluated IVIG treatment for dermatomyositis, and it included only 15 participants. That was until October 2022, he said, when the New England Journal of Medicine published a study comparing a specific brand of IVIG (Octagam) with placebo in 95 people with dermatomyositis.

In the study, 79% of participants treated with IVIG had a total improvement score of at least 20 (minimal improvement), the primary endpoint, at 16 weeks, compared with 44% of those receiving a placebo. Those treated with IVIG also had significant improvements in the CDASI score, a secondary endpoint, compared with those on placebo, he said.

Based on results of this trial, the FDA approved Octagam 10% for dermatomyositis in adults. Dr. Fernandez noted the approval is restricted to the brand of IVIG in the trial, not all IVIG products. However, “the FDA approval is most important to us because it gives us ammunition to fight for insurers to approve IVIG when we feel our patients with dermatomyositis need it,” regardless of the brand.
 

The Potential of JAK1 Inhibitors

An open-label study of the JAK inhibitor tofacitinib, published in December 2020, showed that mean changes in CDASI activity scores at 12 weeks were statistically significant compared with baseline in 10 people with dermatomyositis. “The importance of this study is that it is proof of concept that JAK inhibition can be effective for treating dermatomyositis, especially with active skin disease,” Dr. Fernandez said.

In addition, two large phase 3 trials are evaluating JAK inhibitor safety and efficacy for treating dermatomyositis. One is the VALOR trial, currently recruiting people with recalcitrant dermatomyositis to evaluate treatment with brepocitinib. Researchers in France are looking at another JAK inhibitor, baricitinib, for treating relapsing or treatment-naive dermatomyositis. Recruitment for the BIRD clinical trial is ongoing.

Monoclonal Antibody Showing Promise

“When it comes to looking specifically at dermatomyositis cutaneous disease, it’s been found that the levels of IFN beta correlate best with not only lesional skin type 1 IFN inflammatory signatures but also overall clinical disease activity,” Dr. Fernandez said. This correlation is stronger than for any other IFN-1-type cytokine active in the disorder.

“Perhaps blocking IFN beta might be best way to get control of dermatomyositis activity,” he added.

With that in mind, a phase 2 trial of dazukibart presented at the American Academy of Dermatology 2023 annual meeting highlighted the promise of this agent that targets type 1 IFN beta.

The primary endpoint was improvement in CDASI at 12 weeks. “This medication has remarkable efficacy,” Dr. Fernandez said. “We were one of the sites for this trial. Despite being blinded, there was no question about who was receiving drug and who was receiving placebo.”

“A minimal clinical improvement in disease activity was seen in more than 90%, so almost every patient who received this medication had meaningful improvement,” he added.

Based on the results, the manufacturer, Pfizer, is recruiting participants for a phase 3 trial to further assess dazukibart in dermatomyositis and polymyositis. Dr. Fernandez said, “This is a story you should pay attention to if you treat any dermatomyositis patients at all.”

Regarding these emerging therapies for CLE and dermatomyositis, “This looks very much like the early days of psoriasis, in the early 2000s, when there was a lot of activity developing treatments,” Dr. Fernandez said. “I will predict that within 10 years, we will have multiple novel agents available that will probably work better than anything we have today.”

Dr. Fernandez reported receiving grant and/or research support from Alexion, Incyte, Mallinckrodt Pharmaceuticals, Novartis, Pfizer, and Priovant Therapeutics; acting as a consultant or advisory board member for AbbVie, Biogen, Mallinckrodt Pharmaceuticals; and being a member of the speaker bureau or receiving honoraria for non-CME from AbbVie, Kyowa Kirin, and Mallinckrodt Pharmaceuticals.

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — Advances in treating medical conditions rarely emerge in a straight line. Oftentimes, progress comes in fits and starts, and therapies to treat cutaneous lupus erythematosus (CLE) and dermatomyositis are no exception.

Beyond approved treatments that deserve more attention, like belimumab, approved by the Food and Drug Administration (FDA) for systemic lupus erythematosus (SLE) in 2011, and Octagam 10%, an intravenous immune globulin (IVIG) preparation approved for dermatomyositis in 2021, anticipation is growing for emerging therapies and their potential to provide relief to patients, Anthony Fernandez, MD, PhD, said at the ODAC Dermatology, Aesthetic & Surgical Conference. The tyrosine kinase 2 (TYK2) inhibitor deucravacitinib, Janus kinase (JAK) inhibitors brepocitinib and baricitinib, and the monoclonal antibody anifrolumab, he noted, are prime examples.

“There have been significant advances in the development of treatments for lupus erythematosus and dermatomyositis. In my opinion, this is the start of what will be the most exciting decade in the history of these two diseases,” said Dr. Fernandez, director of medical dermatology at the Cleveland Clinic.
 

Emerging Treatments for Cutaneous Lupus

Although SLE can involve many organ systems, the skin is one of the most affected. There are specific cutaneous lesions categorized as either acute cutaneous lupus, subacute cutaneous lupus, or chronic cutaneous lupus.

The oral TYK2 inhibitor deucravacitinib, for example, should be able to dampen interleukin responses in people with CLE, Dr. Fernandez said. Deucravacitinib was approved by the FDA to treat psoriasis in September 2022.

Cleveland Clinic Foundation

A phase 2 study published in 2023 focused on this agent for relief of systemic lupus. Improvements in cutaneous disease were a secondary endpoint. The trial demonstrated that the patients treated with deucravacitinib achieved a 56%-70% CLASI-50 response, depending on dosing, compared with a 17% response among those on placebo at week 48.

Based on the trial results, recruitment has begun for a phase 2 trial to evaluate deucravacitinib, compared with placebo, in patients with discoid and/or subacute cutaneous lupus. “This may be another medicine we have available to give to any of our patients with cutaneous lupus,” Dr. Fernandez said.
 

Anifrolumab Appears Promising

The FDA approval of anifrolumab, a type I interferon (IFN) receptor antagonist, for treating moderate to severe SLE in July 2021, for example, is good news for dermatologists and their patients, added Dr. Fernandez. “Almost immediately after approval, case studies showed marked improvement in patients with refractory cutaneous lupus.” While the therapy was approved for treating systemic lupus, it allows for off-label treatment of the cutaneous predominant form of the disease, he said.

Furthermore, the manufacturer of anifrolumab, AstraZeneca, is launching the LAVENDER clinical trial to assess the monoclonal antibody specifically for treating CLE. “This is a big deal because we may be able to prescribe anifrolumab for our cutaneous lupus patients who don’t have systemic lupus,” Dr. Fernandez said.

Phase 3 data supported use the of anifrolumab in systemic lupus, including the TULIP-2 trial, which demonstrated its superiority to placebo for reducing severity of systemic disease and lowering corticosteroid use. A study published in March 2023 of 11 patients showed that they had a “very fast response” to the agent, Dr. Fernandez said, with a 50% or greater improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score reached by all participants at week 16. Improvements of 50% or more in this scoring system are considered clinically meaningful, he added.
 

Upcoming Dermatomyositis Treatments

Why highlight emerging therapies for CLE and dermatomyositis in the same ODAC presentation? Although distinct conditions, these autoimmune conditions are both mediated by type 1 IFN inflammation.

Dermatomyositis is a relatively rare immune-mediated disease that most commonly affects the skin and muscle. Doctors score disease presentation, activity, and clinical improvements on a scale similar to CLASI for cutaneous lupus, the CDASI or Cutaneous Dermatomyositis Disease Area and Severity Index. Among people with CDASI activity scores of at least 14, which is the threshold for moderate to severe disease, a 20% improvement is clinically meaningful, Dr. Fernandez said. In addition, a 40% or greater improvement correlates with significant improvements in quality of life.

There is now more evidence for the use of IVIG to treat dermatomyositis. “Among those of us who treat dermatomyositis on a regular basis, we believe IVIG is the most potent treatment. We’ve known that for a long time,” Dr. Fernandez said.

Despite this tenet, for years, there was only one placebo-controlled trial, published in 1993, that evaluated IVIG treatment for dermatomyositis, and it included only 15 participants. That was until October 2022, he said, when the New England Journal of Medicine published a study comparing a specific brand of IVIG (Octagam) with placebo in 95 people with dermatomyositis.

In the study, 79% of participants treated with IVIG had a total improvement score of at least 20 (minimal improvement), the primary endpoint, at 16 weeks, compared with 44% of those receiving a placebo. Those treated with IVIG also had significant improvements in the CDASI score, a secondary endpoint, compared with those on placebo, he said.

Based on results of this trial, the FDA approved Octagam 10% for dermatomyositis in adults. Dr. Fernandez noted the approval is restricted to the brand of IVIG in the trial, not all IVIG products. However, “the FDA approval is most important to us because it gives us ammunition to fight for insurers to approve IVIG when we feel our patients with dermatomyositis need it,” regardless of the brand.
 

The Potential of JAK1 Inhibitors

An open-label study of the JAK inhibitor tofacitinib, published in December 2020, showed that mean changes in CDASI activity scores at 12 weeks were statistically significant compared with baseline in 10 people with dermatomyositis. “The importance of this study is that it is proof of concept that JAK inhibition can be effective for treating dermatomyositis, especially with active skin disease,” Dr. Fernandez said.

In addition, two large phase 3 trials are evaluating JAK inhibitor safety and efficacy for treating dermatomyositis. One is the VALOR trial, currently recruiting people with recalcitrant dermatomyositis to evaluate treatment with brepocitinib. Researchers in France are looking at another JAK inhibitor, baricitinib, for treating relapsing or treatment-naive dermatomyositis. Recruitment for the BIRD clinical trial is ongoing.

Monoclonal Antibody Showing Promise

“When it comes to looking specifically at dermatomyositis cutaneous disease, it’s been found that the levels of IFN beta correlate best with not only lesional skin type 1 IFN inflammatory signatures but also overall clinical disease activity,” Dr. Fernandez said. This correlation is stronger than for any other IFN-1-type cytokine active in the disorder.

“Perhaps blocking IFN beta might be best way to get control of dermatomyositis activity,” he added.

With that in mind, a phase 2 trial of dazukibart presented at the American Academy of Dermatology 2023 annual meeting highlighted the promise of this agent that targets type 1 IFN beta.

The primary endpoint was improvement in CDASI at 12 weeks. “This medication has remarkable efficacy,” Dr. Fernandez said. “We were one of the sites for this trial. Despite being blinded, there was no question about who was receiving drug and who was receiving placebo.”

“A minimal clinical improvement in disease activity was seen in more than 90%, so almost every patient who received this medication had meaningful improvement,” he added.

Based on the results, the manufacturer, Pfizer, is recruiting participants for a phase 3 trial to further assess dazukibart in dermatomyositis and polymyositis. Dr. Fernandez said, “This is a story you should pay attention to if you treat any dermatomyositis patients at all.”

Regarding these emerging therapies for CLE and dermatomyositis, “This looks very much like the early days of psoriasis, in the early 2000s, when there was a lot of activity developing treatments,” Dr. Fernandez said. “I will predict that within 10 years, we will have multiple novel agents available that will probably work better than anything we have today.”

Dr. Fernandez reported receiving grant and/or research support from Alexion, Incyte, Mallinckrodt Pharmaceuticals, Novartis, Pfizer, and Priovant Therapeutics; acting as a consultant or advisory board member for AbbVie, Biogen, Mallinckrodt Pharmaceuticals; and being a member of the speaker bureau or receiving honoraria for non-CME from AbbVie, Kyowa Kirin, and Mallinckrodt Pharmaceuticals.

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — Advances in treating medical conditions rarely emerge in a straight line. Oftentimes, progress comes in fits and starts, and therapies to treat cutaneous lupus erythematosus (CLE) and dermatomyositis are no exception.

Beyond approved treatments that deserve more attention, like belimumab, approved by the Food and Drug Administration (FDA) for systemic lupus erythematosus (SLE) in 2011, and Octagam 10%, an intravenous immune globulin (IVIG) preparation approved for dermatomyositis in 2021, anticipation is growing for emerging therapies and their potential to provide relief to patients, Anthony Fernandez, MD, PhD, said at the ODAC Dermatology, Aesthetic & Surgical Conference. The tyrosine kinase 2 (TYK2) inhibitor deucravacitinib, Janus kinase (JAK) inhibitors brepocitinib and baricitinib, and the monoclonal antibody anifrolumab, he noted, are prime examples.

“There have been significant advances in the development of treatments for lupus erythematosus and dermatomyositis. In my opinion, this is the start of what will be the most exciting decade in the history of these two diseases,” said Dr. Fernandez, director of medical dermatology at the Cleveland Clinic.
 

Emerging Treatments for Cutaneous Lupus

Although SLE can involve many organ systems, the skin is one of the most affected. There are specific cutaneous lesions categorized as either acute cutaneous lupus, subacute cutaneous lupus, or chronic cutaneous lupus.

The oral TYK2 inhibitor deucravacitinib, for example, should be able to dampen interleukin responses in people with CLE, Dr. Fernandez said. Deucravacitinib was approved by the FDA to treat psoriasis in September 2022.

Cleveland Clinic Foundation

A phase 2 study published in 2023 focused on this agent for relief of systemic lupus. Improvements in cutaneous disease were a secondary endpoint. The trial demonstrated that the patients treated with deucravacitinib achieved a 56%-70% CLASI-50 response, depending on dosing, compared with a 17% response among those on placebo at week 48.

Based on the trial results, recruitment has begun for a phase 2 trial to evaluate deucravacitinib, compared with placebo, in patients with discoid and/or subacute cutaneous lupus. “This may be another medicine we have available to give to any of our patients with cutaneous lupus,” Dr. Fernandez said.
 

Anifrolumab Appears Promising

The FDA approval of anifrolumab, a type I interferon (IFN) receptor antagonist, for treating moderate to severe SLE in July 2021, for example, is good news for dermatologists and their patients, added Dr. Fernandez. “Almost immediately after approval, case studies showed marked improvement in patients with refractory cutaneous lupus.” While the therapy was approved for treating systemic lupus, it allows for off-label treatment of the cutaneous predominant form of the disease, he said.

Furthermore, the manufacturer of anifrolumab, AstraZeneca, is launching the LAVENDER clinical trial to assess the monoclonal antibody specifically for treating CLE. “This is a big deal because we may be able to prescribe anifrolumab for our cutaneous lupus patients who don’t have systemic lupus,” Dr. Fernandez said.

Phase 3 data supported use the of anifrolumab in systemic lupus, including the TULIP-2 trial, which demonstrated its superiority to placebo for reducing severity of systemic disease and lowering corticosteroid use. A study published in March 2023 of 11 patients showed that they had a “very fast response” to the agent, Dr. Fernandez said, with a 50% or greater improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score reached by all participants at week 16. Improvements of 50% or more in this scoring system are considered clinically meaningful, he added.
 

Upcoming Dermatomyositis Treatments

Why highlight emerging therapies for CLE and dermatomyositis in the same ODAC presentation? Although distinct conditions, these autoimmune conditions are both mediated by type 1 IFN inflammation.

Dermatomyositis is a relatively rare immune-mediated disease that most commonly affects the skin and muscle. Doctors score disease presentation, activity, and clinical improvements on a scale similar to CLASI for cutaneous lupus, the CDASI or Cutaneous Dermatomyositis Disease Area and Severity Index. Among people with CDASI activity scores of at least 14, which is the threshold for moderate to severe disease, a 20% improvement is clinically meaningful, Dr. Fernandez said. In addition, a 40% or greater improvement correlates with significant improvements in quality of life.

There is now more evidence for the use of IVIG to treat dermatomyositis. “Among those of us who treat dermatomyositis on a regular basis, we believe IVIG is the most potent treatment. We’ve known that for a long time,” Dr. Fernandez said.

Despite this tenet, for years, there was only one placebo-controlled trial, published in 1993, that evaluated IVIG treatment for dermatomyositis, and it included only 15 participants. That was until October 2022, he said, when the New England Journal of Medicine published a study comparing a specific brand of IVIG (Octagam) with placebo in 95 people with dermatomyositis.

In the study, 79% of participants treated with IVIG had a total improvement score of at least 20 (minimal improvement), the primary endpoint, at 16 weeks, compared with 44% of those receiving a placebo. Those treated with IVIG also had significant improvements in the CDASI score, a secondary endpoint, compared with those on placebo, he said.

Based on results of this trial, the FDA approved Octagam 10% for dermatomyositis in adults. Dr. Fernandez noted the approval is restricted to the brand of IVIG in the trial, not all IVIG products. However, “the FDA approval is most important to us because it gives us ammunition to fight for insurers to approve IVIG when we feel our patients with dermatomyositis need it,” regardless of the brand.
 

The Potential of JAK1 Inhibitors

An open-label study of the JAK inhibitor tofacitinib, published in December 2020, showed that mean changes in CDASI activity scores at 12 weeks were statistically significant compared with baseline in 10 people with dermatomyositis. “The importance of this study is that it is proof of concept that JAK inhibition can be effective for treating dermatomyositis, especially with active skin disease,” Dr. Fernandez said.

In addition, two large phase 3 trials are evaluating JAK inhibitor safety and efficacy for treating dermatomyositis. One is the VALOR trial, currently recruiting people with recalcitrant dermatomyositis to evaluate treatment with brepocitinib. Researchers in France are looking at another JAK inhibitor, baricitinib, for treating relapsing or treatment-naive dermatomyositis. Recruitment for the BIRD clinical trial is ongoing.

Monoclonal Antibody Showing Promise

“When it comes to looking specifically at dermatomyositis cutaneous disease, it’s been found that the levels of IFN beta correlate best with not only lesional skin type 1 IFN inflammatory signatures but also overall clinical disease activity,” Dr. Fernandez said. This correlation is stronger than for any other IFN-1-type cytokine active in the disorder.

“Perhaps blocking IFN beta might be best way to get control of dermatomyositis activity,” he added.

With that in mind, a phase 2 trial of dazukibart presented at the American Academy of Dermatology 2023 annual meeting highlighted the promise of this agent that targets type 1 IFN beta.

The primary endpoint was improvement in CDASI at 12 weeks. “This medication has remarkable efficacy,” Dr. Fernandez said. “We were one of the sites for this trial. Despite being blinded, there was no question about who was receiving drug and who was receiving placebo.”

“A minimal clinical improvement in disease activity was seen in more than 90%, so almost every patient who received this medication had meaningful improvement,” he added.

Based on the results, the manufacturer, Pfizer, is recruiting participants for a phase 3 trial to further assess dazukibart in dermatomyositis and polymyositis. Dr. Fernandez said, “This is a story you should pay attention to if you treat any dermatomyositis patients at all.”

Regarding these emerging therapies for CLE and dermatomyositis, “This looks very much like the early days of psoriasis, in the early 2000s, when there was a lot of activity developing treatments,” Dr. Fernandez said. “I will predict that within 10 years, we will have multiple novel agents available that will probably work better than anything we have today.”

Dr. Fernandez reported receiving grant and/or research support from Alexion, Incyte, Mallinckrodt Pharmaceuticals, Novartis, Pfizer, and Priovant Therapeutics; acting as a consultant or advisory board member for AbbVie, Biogen, Mallinckrodt Pharmaceuticals; and being a member of the speaker bureau or receiving honoraria for non-CME from AbbVie, Kyowa Kirin, and Mallinckrodt Pharmaceuticals.

A version of this article appeared on Medscape.com.

In late December 2023, Brazil’s National Health Surveillance Agency (ANVISA) suspended the commercialization of approximately 1200 hair creams because of reports of eye irritation and temporary blindness.

A similar measure encompassing all hair creams sold in the country had already been announced by the agency in March. However, after a few weeks, ANVISA issued a resolution with rules for the products’ commercialization, allowing them back on the shelves.

With the new resolution, the sale of products that do not comply with the standards has once again been suspended. The reason is that reports of adverse events have reemerged. These events include temporary vision loss, headaches, and burning, tearing, itching, redness, and swelling of the eyes. According to reports, these adverse effects occurred mainly in people who used the specific products before swimming in the sea or in pools, or even going out in the rain.

The banned products contain 20% or more ethoxylated alcohols in their formulations. Products containing methylchloroisothiazolinone and methylisothiazolinone were already prohibited. These substances, used as preservatives, are considered toxic to the skin and mucous membranes, potentially causing allergies and burns to the eyes and skin. They also have a high pulmonary and neurological toxicity. All these substances are eye irritants and can cause chemical keratitis. In extreme cases, corneal ulcers may develop, leading to vision loss.

The Brazilian Council of Ophthalmology also issued a warning on these products. It emphasized that, in addition to the sales prohibition, consumers should check the labels of hair creams to make sure that these toxic substances are not present in the product formulation.

The ANVISA website contains a list of creams that are considered safe and have not had their commercialization suspended, along with links to adverse event notifications reported by healthcare professionals or consumers.

For consumers who have recently used hair creams, the agency advises careful hair washing, including tilting the head backward to prevent the product from coming into contact with the eye area. If there is accidental eye contact, the eyes should be washed with plenty of water.

If there are any undesired effects after using these products, users should immediately seek the nearest healthcare service. Treatment should be individualized, possibly including ocular occlusion and the use of eye drops containing antibiotics or corticosteroids, among other medications.

Not every patient has easy access to an ophthalmologist in an emergency, so it is crucial for general practitioners to be prepared for initial care. In this regard, one of the most important measures is eye washing with copious amounts of clean water or saline solution for 5-10 minutes.

Eye itching is a frequent manifestation of using hair creams, and scratching the area may worsen the condition. Ocular occlusion can protect the cornea until an evaluation can be performed by a specialist.

Although we prefer our patients to stay away from these creams, it is also important to disseminate this information and advise them to read labels and use safe cosmetics.
 

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

In late December 2023, Brazil’s National Health Surveillance Agency (ANVISA) suspended the commercialization of approximately 1200 hair creams because of reports of eye irritation and temporary blindness.

A similar measure encompassing all hair creams sold in the country had already been announced by the agency in March. However, after a few weeks, ANVISA issued a resolution with rules for the products’ commercialization, allowing them back on the shelves.

With the new resolution, the sale of products that do not comply with the standards has once again been suspended. The reason is that reports of adverse events have reemerged. These events include temporary vision loss, headaches, and burning, tearing, itching, redness, and swelling of the eyes. According to reports, these adverse effects occurred mainly in people who used the specific products before swimming in the sea or in pools, or even going out in the rain.

The banned products contain 20% or more ethoxylated alcohols in their formulations. Products containing methylchloroisothiazolinone and methylisothiazolinone were already prohibited. These substances, used as preservatives, are considered toxic to the skin and mucous membranes, potentially causing allergies and burns to the eyes and skin. They also have a high pulmonary and neurological toxicity. All these substances are eye irritants and can cause chemical keratitis. In extreme cases, corneal ulcers may develop, leading to vision loss.

The Brazilian Council of Ophthalmology also issued a warning on these products. It emphasized that, in addition to the sales prohibition, consumers should check the labels of hair creams to make sure that these toxic substances are not present in the product formulation.

The ANVISA website contains a list of creams that are considered safe and have not had their commercialization suspended, along with links to adverse event notifications reported by healthcare professionals or consumers.

For consumers who have recently used hair creams, the agency advises careful hair washing, including tilting the head backward to prevent the product from coming into contact with the eye area. If there is accidental eye contact, the eyes should be washed with plenty of water.

If there are any undesired effects after using these products, users should immediately seek the nearest healthcare service. Treatment should be individualized, possibly including ocular occlusion and the use of eye drops containing antibiotics or corticosteroids, among other medications.

Not every patient has easy access to an ophthalmologist in an emergency, so it is crucial for general practitioners to be prepared for initial care. In this regard, one of the most important measures is eye washing with copious amounts of clean water or saline solution for 5-10 minutes.

Eye itching is a frequent manifestation of using hair creams, and scratching the area may worsen the condition. Ocular occlusion can protect the cornea until an evaluation can be performed by a specialist.

Although we prefer our patients to stay away from these creams, it is also important to disseminate this information and advise them to read labels and use safe cosmetics.
 

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

In late December 2023, Brazil’s National Health Surveillance Agency (ANVISA) suspended the commercialization of approximately 1200 hair creams because of reports of eye irritation and temporary blindness.

A similar measure encompassing all hair creams sold in the country had already been announced by the agency in March. However, after a few weeks, ANVISA issued a resolution with rules for the products’ commercialization, allowing them back on the shelves.

With the new resolution, the sale of products that do not comply with the standards has once again been suspended. The reason is that reports of adverse events have reemerged. These events include temporary vision loss, headaches, and burning, tearing, itching, redness, and swelling of the eyes. According to reports, these adverse effects occurred mainly in people who used the specific products before swimming in the sea or in pools, or even going out in the rain.

The banned products contain 20% or more ethoxylated alcohols in their formulations. Products containing methylchloroisothiazolinone and methylisothiazolinone were already prohibited. These substances, used as preservatives, are considered toxic to the skin and mucous membranes, potentially causing allergies and burns to the eyes and skin. They also have a high pulmonary and neurological toxicity. All these substances are eye irritants and can cause chemical keratitis. In extreme cases, corneal ulcers may develop, leading to vision loss.

The Brazilian Council of Ophthalmology also issued a warning on these products. It emphasized that, in addition to the sales prohibition, consumers should check the labels of hair creams to make sure that these toxic substances are not present in the product formulation.

The ANVISA website contains a list of creams that are considered safe and have not had their commercialization suspended, along with links to adverse event notifications reported by healthcare professionals or consumers.

For consumers who have recently used hair creams, the agency advises careful hair washing, including tilting the head backward to prevent the product from coming into contact with the eye area. If there is accidental eye contact, the eyes should be washed with plenty of water.

If there are any undesired effects after using these products, users should immediately seek the nearest healthcare service. Treatment should be individualized, possibly including ocular occlusion and the use of eye drops containing antibiotics or corticosteroids, among other medications.

Not every patient has easy access to an ophthalmologist in an emergency, so it is crucial for general practitioners to be prepared for initial care. In this regard, one of the most important measures is eye washing with copious amounts of clean water or saline solution for 5-10 minutes.

Eye itching is a frequent manifestation of using hair creams, and scratching the area may worsen the condition. Ocular occlusion can protect the cornea until an evaluation can be performed by a specialist.

Although we prefer our patients to stay away from these creams, it is also important to disseminate this information and advise them to read labels and use safe cosmetics.
 

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — There are subtleties and nuances to diagnosing, treating, and monitoring the progress of treatment of hair loss in children. Moreover, hair loss in children can be challenging because it can be caused by a range of conditions, some common and others relatively rare.

Michelle Oboite, MD, shared tips on how to distinguish types of hair loss, when to treat with medications such as topical corticosteroids or Janus kinase (JAK) inhibitors, and why shared decision-making is important, at the ODAC Dermatology, Aesthetic & Surgical Conference.

What these conditions share is that they can negatively affect the quality of life for a child or teenager when the condition leads to anxiety, teasing, or bullying. “It is very isolating to have this condition that everyone in the world can see that you have and judge you for it,” said Dr. Oboite, an attending physician in the dermatology section of Children’s Hospital of Philadelphia.

While alopecia areata, tinea capitis, and trichotillomania are more common, other causes of hair loss in children include androgenetic alopecia, primary scarring alopecias, such as central centrifugal cicatricial alopecia, and dissecting cellulitis. Others are lichen planopilaris and genetic conditions, including loose anagen syndrome, uncombable hair syndrome, and “something so rare” — it has no acronym — autosomal recessive hypotrichosis with recurrent skin vesicles, Dr. Oboite said.
 

Alopecia Areata

Alopecia areata can differ from child to child and can appear in different stages: A localized patch stage, a diffuse patchy stage, or alopecia universalis. In this last stage, the child has already lost most or all the hair on the scalp and eyebrows, as well as the eyelashes.

The decision to treat or not to treat, particularly in younger children, should be on the basis of shared decision-making between a healthcare provider and caregiver, said Dr. Oboite, who is also an assistant professor of clinical dermatology at the University of Pennsylvania, Philadelphia.

Some younger children may not experience any negative impact from the condition, so waiting until they are older is an option.

Also, consider the impact of treatment on a child. Some therapies require frequent blood draws for monitoring, and some topical therapies that are applied multiple times a day “can be very overwhelming” for young children, Dr. Oboite said.

Most children with alopecia areata are healthy and do not need extensive screening laboratory testing. However, one exception is if thyroid dysfunction, commonly associated with alopecia areata, is suspected.

For alopecia areata, Dr. Oboite recommends starting with topical therapies, either topical corticosteroids (as first line) or topical JAK inhibitors (either topical ruxolitinib or compounded topical tofacitinib, both off-label for this indication).

Topical corticosteroids can be effective, but “you want to be thoughtful of the strength you’re using, the application frequency, and then the total amount of surface area that you’re treating,” Dr. Oboite said. Too potent or too much of a topical corticosteroid increases the risk for atrophy and systemic absorption, respectively. To reduce the risk, she reserves the use of ultrahigh-potency topical corticosteroids, such as clobetasol, for children ages 10 years or older. For children younger than 10 years, she recommends using mid-high-potency topical corticosteroids instead.

She recommends once-a-day application around bedtime 5 days a week, generally Monday through Friday to make it easier to remember.

“For children who have over 50% of the scalp involved, I do consider systemic therapy,” Dr. Oboite said. This can include oral steroids such as dexamethasone, prednisone, or prednisolone. For children with recalcitrant disease, she is more likely to use the oral JAK inhibitor ritlecitinib because it was recently approved by the Food and Drug Administration for treating severe alopecia areata in children 12 years and older and in adults.

Another strategy Dr. Oboite uses is to add low-dose oral minoxidil as an adjuvant to other systemic therapy. “I find that it helps with faster hair regrowth,” she said.
 

Tinea Capitis

Oral treatment is indicated for tinea capitis. “Topicals just don’t really clear this,” Dr. Oboite said. Also, talk to patients and families about preventing reinfection with the dermatophyte that causes this condition. “Make sure we’re cleaning hats, combs, brushes, and pillowcases. That is really important.”

Some patients can develop a widespread rash while on treatment. But in most cases, it’s not an adverse reaction to the medication but rather an indication that the body’s response is revving up, she noted.

Griseofulvin 20 mg/kg/d is one treatment option. Another is terbinafine (using weight-based dosing). A tip with terbinafine is that because the tablet needs to be crushed for a young child, “you can put it in anything, besides applesauce or yogurt with fruit on the bottom, which can be acidic and reduce the effectiveness of the medication,” Dr. Oboite said.

For cases of severe, inflammatory tinea capitis such as a kerion, “I will say you have to hold the hands of these patients, the journey can be long,” she added.
 

Trichotillomania

Trichotillomania occurs when someone cannot stop pulling their own hair, and in the early phases, it can be confused with alopecia areata. A thorough history and examination of the patient can help distinguish the two conditions. Sometimes a child or teen has a history of anxiety-related behaviors like nail biting that points to trichotillomania. Another tip is to use a dermatoscope to help distinguish hair loss conditions because it avoids having to do as many biopsies in children.

Redirection therapy can work for younger children, and cognitive behavioral therapy (CBT) can help older children with trichotillomania. In response to a question during the Q&A period, Dr. Oboite said psychiatrists or psychologists can perform CBT. If it takes time to get an appointment, there are some CBT apps that can help in the meantime, she said.

“One thing really important is to not blame the child,” Dr. Oboite said. “Most children don’t even know that they’re doing this. This is often not a behavior that is being done on purpose.”

Androgenetic Alopecia

Rarely, children and teenagers can also present with androgenetic alopecia, which Dr. Oboite has successfully treated with topical minoxidil, applied once a day before increasing to twice a day if tolerated. “I will tell them that when they pick it up, it will say ‘you should not use in children.’ But it actually can be used in children safely.”

Low-dose oral minoxidil is another option. Both treatments require a commitment by patients and parents because they are “taking this for a long time.”
 

Loose Anagen and Uncombable Hair Syndromes

A rare genetic form of hair loss is called loose anagen syndrome. Children with this disorder will have thin hair that is easily pulled out without a lot of force. Their hair appears to typically only grow to a certain length (such as to the nape of the neck) and then stops.

Another genetic hair loss condition is uncombable hair syndrome. It can cause hair to grow out of the scalp in all directions, and as the name suggests, it is almost impossible to comb or brush down. Along with loose anagen syndrome, uncombable hair syndrome tends to improve as the child gets older. “The key point here is telling parents that it can get better with time,” Dr. Oboite said.
 

A Condition With No Well-Known Acronym

She described a child she treated who had hair that never grew and was easily broken. The patient’s skin was prone to bruising, and her fingernails would easily fall off after trauma; her dentist noted that she had no buds for adult teeth on x-rays. These different presentations are important because hair, teeth, and nails all come from the same ectoderm germ line in embryo development, Dr. Oboite said.

Exome sequencing revealed the girl had a very rare diagnosis called autosomal recessive hypotrichosis with recurrent skin vesicles. “So, it is really important to recognize that children who are presenting with hair issues can have a genetic, underlying condition,” she said. Examining the skin, nails, and teeth, in addition to the hair, can be clues to these very rare diagnoses.

Some of these hair loss conditions in children can be challenging to diagnose and manage, Dr. Oboite said. “So don’t be afraid to ask for help on complex or rare cases.” Pediatric dermatologists “are always happy to help you. Hair loss is daunting, and hair loss in children can be even more daunting,” but the rewards of accurate diagnosis and successful treatment can be great, she said.

Dr. Oboite reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — There are subtleties and nuances to diagnosing, treating, and monitoring the progress of treatment of hair loss in children. Moreover, hair loss in children can be challenging because it can be caused by a range of conditions, some common and others relatively rare.

Michelle Oboite, MD, shared tips on how to distinguish types of hair loss, when to treat with medications such as topical corticosteroids or Janus kinase (JAK) inhibitors, and why shared decision-making is important, at the ODAC Dermatology, Aesthetic & Surgical Conference.

What these conditions share is that they can negatively affect the quality of life for a child or teenager when the condition leads to anxiety, teasing, or bullying. “It is very isolating to have this condition that everyone in the world can see that you have and judge you for it,” said Dr. Oboite, an attending physician in the dermatology section of Children’s Hospital of Philadelphia.

While alopecia areata, tinea capitis, and trichotillomania are more common, other causes of hair loss in children include androgenetic alopecia, primary scarring alopecias, such as central centrifugal cicatricial alopecia, and dissecting cellulitis. Others are lichen planopilaris and genetic conditions, including loose anagen syndrome, uncombable hair syndrome, and “something so rare” — it has no acronym — autosomal recessive hypotrichosis with recurrent skin vesicles, Dr. Oboite said.
 

Alopecia Areata

Alopecia areata can differ from child to child and can appear in different stages: A localized patch stage, a diffuse patchy stage, or alopecia universalis. In this last stage, the child has already lost most or all the hair on the scalp and eyebrows, as well as the eyelashes.

The decision to treat or not to treat, particularly in younger children, should be on the basis of shared decision-making between a healthcare provider and caregiver, said Dr. Oboite, who is also an assistant professor of clinical dermatology at the University of Pennsylvania, Philadelphia.

Some younger children may not experience any negative impact from the condition, so waiting until they are older is an option.

Also, consider the impact of treatment on a child. Some therapies require frequent blood draws for monitoring, and some topical therapies that are applied multiple times a day “can be very overwhelming” for young children, Dr. Oboite said.

Most children with alopecia areata are healthy and do not need extensive screening laboratory testing. However, one exception is if thyroid dysfunction, commonly associated with alopecia areata, is suspected.

For alopecia areata, Dr. Oboite recommends starting with topical therapies, either topical corticosteroids (as first line) or topical JAK inhibitors (either topical ruxolitinib or compounded topical tofacitinib, both off-label for this indication).

Topical corticosteroids can be effective, but “you want to be thoughtful of the strength you’re using, the application frequency, and then the total amount of surface area that you’re treating,” Dr. Oboite said. Too potent or too much of a topical corticosteroid increases the risk for atrophy and systemic absorption, respectively. To reduce the risk, she reserves the use of ultrahigh-potency topical corticosteroids, such as clobetasol, for children ages 10 years or older. For children younger than 10 years, she recommends using mid-high-potency topical corticosteroids instead.

She recommends once-a-day application around bedtime 5 days a week, generally Monday through Friday to make it easier to remember.

“For children who have over 50% of the scalp involved, I do consider systemic therapy,” Dr. Oboite said. This can include oral steroids such as dexamethasone, prednisone, or prednisolone. For children with recalcitrant disease, she is more likely to use the oral JAK inhibitor ritlecitinib because it was recently approved by the Food and Drug Administration for treating severe alopecia areata in children 12 years and older and in adults.

Another strategy Dr. Oboite uses is to add low-dose oral minoxidil as an adjuvant to other systemic therapy. “I find that it helps with faster hair regrowth,” she said.
 

Tinea Capitis

Oral treatment is indicated for tinea capitis. “Topicals just don’t really clear this,” Dr. Oboite said. Also, talk to patients and families about preventing reinfection with the dermatophyte that causes this condition. “Make sure we’re cleaning hats, combs, brushes, and pillowcases. That is really important.”

Some patients can develop a widespread rash while on treatment. But in most cases, it’s not an adverse reaction to the medication but rather an indication that the body’s response is revving up, she noted.

Griseofulvin 20 mg/kg/d is one treatment option. Another is terbinafine (using weight-based dosing). A tip with terbinafine is that because the tablet needs to be crushed for a young child, “you can put it in anything, besides applesauce or yogurt with fruit on the bottom, which can be acidic and reduce the effectiveness of the medication,” Dr. Oboite said.

For cases of severe, inflammatory tinea capitis such as a kerion, “I will say you have to hold the hands of these patients, the journey can be long,” she added.
 

Trichotillomania

Trichotillomania occurs when someone cannot stop pulling their own hair, and in the early phases, it can be confused with alopecia areata. A thorough history and examination of the patient can help distinguish the two conditions. Sometimes a child or teen has a history of anxiety-related behaviors like nail biting that points to trichotillomania. Another tip is to use a dermatoscope to help distinguish hair loss conditions because it avoids having to do as many biopsies in children.

Redirection therapy can work for younger children, and cognitive behavioral therapy (CBT) can help older children with trichotillomania. In response to a question during the Q&A period, Dr. Oboite said psychiatrists or psychologists can perform CBT. If it takes time to get an appointment, there are some CBT apps that can help in the meantime, she said.

“One thing really important is to not blame the child,” Dr. Oboite said. “Most children don’t even know that they’re doing this. This is often not a behavior that is being done on purpose.”

Androgenetic Alopecia

Rarely, children and teenagers can also present with androgenetic alopecia, which Dr. Oboite has successfully treated with topical minoxidil, applied once a day before increasing to twice a day if tolerated. “I will tell them that when they pick it up, it will say ‘you should not use in children.’ But it actually can be used in children safely.”

Low-dose oral minoxidil is another option. Both treatments require a commitment by patients and parents because they are “taking this for a long time.”
 

Loose Anagen and Uncombable Hair Syndromes

A rare genetic form of hair loss is called loose anagen syndrome. Children with this disorder will have thin hair that is easily pulled out without a lot of force. Their hair appears to typically only grow to a certain length (such as to the nape of the neck) and then stops.

Another genetic hair loss condition is uncombable hair syndrome. It can cause hair to grow out of the scalp in all directions, and as the name suggests, it is almost impossible to comb or brush down. Along with loose anagen syndrome, uncombable hair syndrome tends to improve as the child gets older. “The key point here is telling parents that it can get better with time,” Dr. Oboite said.
 

A Condition With No Well-Known Acronym

She described a child she treated who had hair that never grew and was easily broken. The patient’s skin was prone to bruising, and her fingernails would easily fall off after trauma; her dentist noted that she had no buds for adult teeth on x-rays. These different presentations are important because hair, teeth, and nails all come from the same ectoderm germ line in embryo development, Dr. Oboite said.

Exome sequencing revealed the girl had a very rare diagnosis called autosomal recessive hypotrichosis with recurrent skin vesicles. “So, it is really important to recognize that children who are presenting with hair issues can have a genetic, underlying condition,” she said. Examining the skin, nails, and teeth, in addition to the hair, can be clues to these very rare diagnoses.

Some of these hair loss conditions in children can be challenging to diagnose and manage, Dr. Oboite said. “So don’t be afraid to ask for help on complex or rare cases.” Pediatric dermatologists “are always happy to help you. Hair loss is daunting, and hair loss in children can be even more daunting,” but the rewards of accurate diagnosis and successful treatment can be great, she said.

Dr. Oboite reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — There are subtleties and nuances to diagnosing, treating, and monitoring the progress of treatment of hair loss in children. Moreover, hair loss in children can be challenging because it can be caused by a range of conditions, some common and others relatively rare.

Michelle Oboite, MD, shared tips on how to distinguish types of hair loss, when to treat with medications such as topical corticosteroids or Janus kinase (JAK) inhibitors, and why shared decision-making is important, at the ODAC Dermatology, Aesthetic & Surgical Conference.

What these conditions share is that they can negatively affect the quality of life for a child or teenager when the condition leads to anxiety, teasing, or bullying. “It is very isolating to have this condition that everyone in the world can see that you have and judge you for it,” said Dr. Oboite, an attending physician in the dermatology section of Children’s Hospital of Philadelphia.

While alopecia areata, tinea capitis, and trichotillomania are more common, other causes of hair loss in children include androgenetic alopecia, primary scarring alopecias, such as central centrifugal cicatricial alopecia, and dissecting cellulitis. Others are lichen planopilaris and genetic conditions, including loose anagen syndrome, uncombable hair syndrome, and “something so rare” — it has no acronym — autosomal recessive hypotrichosis with recurrent skin vesicles, Dr. Oboite said.
 

Alopecia Areata

Alopecia areata can differ from child to child and can appear in different stages: A localized patch stage, a diffuse patchy stage, or alopecia universalis. In this last stage, the child has already lost most or all the hair on the scalp and eyebrows, as well as the eyelashes.

The decision to treat or not to treat, particularly in younger children, should be on the basis of shared decision-making between a healthcare provider and caregiver, said Dr. Oboite, who is also an assistant professor of clinical dermatology at the University of Pennsylvania, Philadelphia.

Some younger children may not experience any negative impact from the condition, so waiting until they are older is an option.

Also, consider the impact of treatment on a child. Some therapies require frequent blood draws for monitoring, and some topical therapies that are applied multiple times a day “can be very overwhelming” for young children, Dr. Oboite said.

Most children with alopecia areata are healthy and do not need extensive screening laboratory testing. However, one exception is if thyroid dysfunction, commonly associated with alopecia areata, is suspected.

For alopecia areata, Dr. Oboite recommends starting with topical therapies, either topical corticosteroids (as first line) or topical JAK inhibitors (either topical ruxolitinib or compounded topical tofacitinib, both off-label for this indication).

Topical corticosteroids can be effective, but “you want to be thoughtful of the strength you’re using, the application frequency, and then the total amount of surface area that you’re treating,” Dr. Oboite said. Too potent or too much of a topical corticosteroid increases the risk for atrophy and systemic absorption, respectively. To reduce the risk, she reserves the use of ultrahigh-potency topical corticosteroids, such as clobetasol, for children ages 10 years or older. For children younger than 10 years, she recommends using mid-high-potency topical corticosteroids instead.

She recommends once-a-day application around bedtime 5 days a week, generally Monday through Friday to make it easier to remember.

“For children who have over 50% of the scalp involved, I do consider systemic therapy,” Dr. Oboite said. This can include oral steroids such as dexamethasone, prednisone, or prednisolone. For children with recalcitrant disease, she is more likely to use the oral JAK inhibitor ritlecitinib because it was recently approved by the Food and Drug Administration for treating severe alopecia areata in children 12 years and older and in adults.

Another strategy Dr. Oboite uses is to add low-dose oral minoxidil as an adjuvant to other systemic therapy. “I find that it helps with faster hair regrowth,” she said.
 

Tinea Capitis

Oral treatment is indicated for tinea capitis. “Topicals just don’t really clear this,” Dr. Oboite said. Also, talk to patients and families about preventing reinfection with the dermatophyte that causes this condition. “Make sure we’re cleaning hats, combs, brushes, and pillowcases. That is really important.”

Some patients can develop a widespread rash while on treatment. But in most cases, it’s not an adverse reaction to the medication but rather an indication that the body’s response is revving up, she noted.

Griseofulvin 20 mg/kg/d is one treatment option. Another is terbinafine (using weight-based dosing). A tip with terbinafine is that because the tablet needs to be crushed for a young child, “you can put it in anything, besides applesauce or yogurt with fruit on the bottom, which can be acidic and reduce the effectiveness of the medication,” Dr. Oboite said.

For cases of severe, inflammatory tinea capitis such as a kerion, “I will say you have to hold the hands of these patients, the journey can be long,” she added.
 

Trichotillomania

Trichotillomania occurs when someone cannot stop pulling their own hair, and in the early phases, it can be confused with alopecia areata. A thorough history and examination of the patient can help distinguish the two conditions. Sometimes a child or teen has a history of anxiety-related behaviors like nail biting that points to trichotillomania. Another tip is to use a dermatoscope to help distinguish hair loss conditions because it avoids having to do as many biopsies in children.

Redirection therapy can work for younger children, and cognitive behavioral therapy (CBT) can help older children with trichotillomania. In response to a question during the Q&A period, Dr. Oboite said psychiatrists or psychologists can perform CBT. If it takes time to get an appointment, there are some CBT apps that can help in the meantime, she said.

“One thing really important is to not blame the child,” Dr. Oboite said. “Most children don’t even know that they’re doing this. This is often not a behavior that is being done on purpose.”

Androgenetic Alopecia

Rarely, children and teenagers can also present with androgenetic alopecia, which Dr. Oboite has successfully treated with topical minoxidil, applied once a day before increasing to twice a day if tolerated. “I will tell them that when they pick it up, it will say ‘you should not use in children.’ But it actually can be used in children safely.”

Low-dose oral minoxidil is another option. Both treatments require a commitment by patients and parents because they are “taking this for a long time.”
 

Loose Anagen and Uncombable Hair Syndromes

A rare genetic form of hair loss is called loose anagen syndrome. Children with this disorder will have thin hair that is easily pulled out without a lot of force. Their hair appears to typically only grow to a certain length (such as to the nape of the neck) and then stops.

Another genetic hair loss condition is uncombable hair syndrome. It can cause hair to grow out of the scalp in all directions, and as the name suggests, it is almost impossible to comb or brush down. Along with loose anagen syndrome, uncombable hair syndrome tends to improve as the child gets older. “The key point here is telling parents that it can get better with time,” Dr. Oboite said.
 

A Condition With No Well-Known Acronym

She described a child she treated who had hair that never grew and was easily broken. The patient’s skin was prone to bruising, and her fingernails would easily fall off after trauma; her dentist noted that she had no buds for adult teeth on x-rays. These different presentations are important because hair, teeth, and nails all come from the same ectoderm germ line in embryo development, Dr. Oboite said.

Exome sequencing revealed the girl had a very rare diagnosis called autosomal recessive hypotrichosis with recurrent skin vesicles. “So, it is really important to recognize that children who are presenting with hair issues can have a genetic, underlying condition,” she said. Examining the skin, nails, and teeth, in addition to the hair, can be clues to these very rare diagnoses.

Some of these hair loss conditions in children can be challenging to diagnose and manage, Dr. Oboite said. “So don’t be afraid to ask for help on complex or rare cases.” Pediatric dermatologists “are always happy to help you. Hair loss is daunting, and hair loss in children can be even more daunting,” but the rewards of accurate diagnosis and successful treatment can be great, she said.

Dr. Oboite reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — Amid all the hype, claims, and confusion, there is evidence linking some foods and drinks to an increased risk for acne, psoriasis, atopic dermatitis, rosacea, and other common skin conditions. So, what is the connection in each case? And how can people with any of these skin conditions potentially improve their health and quality of life with dietary changes?

Acne

One of the major areas of interest is diet and acne. “We’ve all heard sugar and dairy are bad, and the Western diet is high in sugar and dairy,” Dr. Shi said at the ODAC Dermatology, Aesthetic & Surgical Conference.
Dairy, red meat, and carbohydrates can break down into leucine, an essential amino acid found in protein. Leucine and sugar together, in turn, can produce insulin and insulin-like growth factor 1 (IGF-1), which, through different pathways, can reach the androgen receptors throughout the body, including the skin. This results in sebogenesis, lipogenesis, and keratinization, which triggers follicular inflammation and results in more of the acne-causing bacteria Cutibacterium acnes. 
Milk and other dairy products also can increase IGF-1 levels, which can alter hormonal mediators and increase acne.
Not all types of dairy milk are created equal, however, when it comes to acne. Dr. Shi wondered why 2% milk has overall color and nutritional content very similar to that of whole milk. “I looked into this.” She discovered that when milk manufacturers remove the fat, they often add whey proteins to restore some nutrients. Whey protein can increase acne, Dr. Shi added. 
“So, if you’re going to choose any milk to drink, I think from an acne perspective, it’s better to use whole milk. If you can get it organic, even better.” Skim milk is the most acnegenic, she said.

Psoriasis

A systematic review of 55 studies evaluating diet and psoriasis found obesity can be an exacerbating factor. The strongest evidence for dietary weight reduction points to a hypocaloric diet in people with overweight or obesity, according to the review. Other evidence suggests alcohol can lower response to treatment and is linked with more severe psoriasis. Furthermore, a gluten-free diet or vitamin D supplements can help some subpopulations of people with psoriasis. 
“An overwhelming majority of our psoriasis patients are vitamin D deficient,” Dr. Shi said. 
The National Psoriasis Foundation (NPF) publishes dietary modification guidelines, updated as recently as November 2023. The NPF states that “there is no diet that will cure psoriatic disease, but there are many ways in which eating healthful food may lessen the severity of symptoms and play a role in lowering the likelihood of developing comorbidities.”
Healthier choices include fruits, vegetables, whole grains, and fat-free or low-fat dairy products. Include lean meats, poultry, fish, beans, eggs, and nuts. Adherence to a Mediterranean diet has been linked to a lower severity of psoriasis.

Atopic Dermatitis

Atopic dermatitis (AD) is “one of the prototypical diseases related to diet,” Dr. Shi said. A different meta-analysis looked at randomized controlled trials of synbiotics (a combination of prebiotics and probiotics) for treatment of AD.
These researchers found that synbiotics do not prevent AD, but they can help treat it in adults and children older than 1 year. In addition, synbiotics are more beneficial than probiotics in treating the condition, although there are no head-to-head comparison studies. In addition, the meta-analysis found that prebiotics alone can lower AD severity.
However, Dr. Shi said, there are no recommendations from the American Academy of Dermatology (AAD) on prebiotics or probiotics for AD, and the AAD does not recommend any supplement or essential oil for AD.
In a 2022 review, investigators ranked the efficacy of different supplements for AD based on available evidence. They found the greatest benefit associated with vitamin D supplementation, followed by vitamin E, probiotics, hemp seed oil, histidine, and oolong tea. They also noted the ‘Six Food Elimination Diet and Autoimmune Protocol’ featured the least amount of evidence to back it up. 

Rosacea

Rosacea appears to be caused by “all the fun things in life” like sunlight, alcohol, chocolate, spicy foods, and caffeine, Dr. Shi said. In people with rosacea, they can cause facial flushing, edema, burning, and an inflammatory response.
Certain foods can activate skin receptors and sensory neurons, which can release neuropeptides that act on mast cells in blood that lead to flushing. The skin-gut axis may also be involved, evidence suggests. “And that is why food has a pretty profound impact on rosacea,” Dr. Shi said. 
Dr. Shi reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — Amid all the hype, claims, and confusion, there is evidence linking some foods and drinks to an increased risk for acne, psoriasis, atopic dermatitis, rosacea, and other common skin conditions. So, what is the connection in each case? And how can people with any of these skin conditions potentially improve their health and quality of life with dietary changes?

Acne

One of the major areas of interest is diet and acne. “We’ve all heard sugar and dairy are bad, and the Western diet is high in sugar and dairy,” Dr. Shi said at the ODAC Dermatology, Aesthetic & Surgical Conference.
Dairy, red meat, and carbohydrates can break down into leucine, an essential amino acid found in protein. Leucine and sugar together, in turn, can produce insulin and insulin-like growth factor 1 (IGF-1), which, through different pathways, can reach the androgen receptors throughout the body, including the skin. This results in sebogenesis, lipogenesis, and keratinization, which triggers follicular inflammation and results in more of the acne-causing bacteria Cutibacterium acnes. 
Milk and other dairy products also can increase IGF-1 levels, which can alter hormonal mediators and increase acne.
Not all types of dairy milk are created equal, however, when it comes to acne. Dr. Shi wondered why 2% milk has overall color and nutritional content very similar to that of whole milk. “I looked into this.” She discovered that when milk manufacturers remove the fat, they often add whey proteins to restore some nutrients. Whey protein can increase acne, Dr. Shi added. 
“So, if you’re going to choose any milk to drink, I think from an acne perspective, it’s better to use whole milk. If you can get it organic, even better.” Skim milk is the most acnegenic, she said.

Psoriasis

A systematic review of 55 studies evaluating diet and psoriasis found obesity can be an exacerbating factor. The strongest evidence for dietary weight reduction points to a hypocaloric diet in people with overweight or obesity, according to the review. Other evidence suggests alcohol can lower response to treatment and is linked with more severe psoriasis. Furthermore, a gluten-free diet or vitamin D supplements can help some subpopulations of people with psoriasis. 
“An overwhelming majority of our psoriasis patients are vitamin D deficient,” Dr. Shi said. 
The National Psoriasis Foundation (NPF) publishes dietary modification guidelines, updated as recently as November 2023. The NPF states that “there is no diet that will cure psoriatic disease, but there are many ways in which eating healthful food may lessen the severity of symptoms and play a role in lowering the likelihood of developing comorbidities.”
Healthier choices include fruits, vegetables, whole grains, and fat-free or low-fat dairy products. Include lean meats, poultry, fish, beans, eggs, and nuts. Adherence to a Mediterranean diet has been linked to a lower severity of psoriasis.

Atopic Dermatitis

Atopic dermatitis (AD) is “one of the prototypical diseases related to diet,” Dr. Shi said. A different meta-analysis looked at randomized controlled trials of synbiotics (a combination of prebiotics and probiotics) for treatment of AD.
These researchers found that synbiotics do not prevent AD, but they can help treat it in adults and children older than 1 year. In addition, synbiotics are more beneficial than probiotics in treating the condition, although there are no head-to-head comparison studies. In addition, the meta-analysis found that prebiotics alone can lower AD severity.
However, Dr. Shi said, there are no recommendations from the American Academy of Dermatology (AAD) on prebiotics or probiotics for AD, and the AAD does not recommend any supplement or essential oil for AD.
In a 2022 review, investigators ranked the efficacy of different supplements for AD based on available evidence. They found the greatest benefit associated with vitamin D supplementation, followed by vitamin E, probiotics, hemp seed oil, histidine, and oolong tea. They also noted the ‘Six Food Elimination Diet and Autoimmune Protocol’ featured the least amount of evidence to back it up. 

Rosacea

Rosacea appears to be caused by “all the fun things in life” like sunlight, alcohol, chocolate, spicy foods, and caffeine, Dr. Shi said. In people with rosacea, they can cause facial flushing, edema, burning, and an inflammatory response.
Certain foods can activate skin receptors and sensory neurons, which can release neuropeptides that act on mast cells in blood that lead to flushing. The skin-gut axis may also be involved, evidence suggests. “And that is why food has a pretty profound impact on rosacea,” Dr. Shi said. 
Dr. Shi reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — Amid all the hype, claims, and confusion, there is evidence linking some foods and drinks to an increased risk for acne, psoriasis, atopic dermatitis, rosacea, and other common skin conditions. So, what is the connection in each case? And how can people with any of these skin conditions potentially improve their health and quality of life with dietary changes?

Acne

One of the major areas of interest is diet and acne. “We’ve all heard sugar and dairy are bad, and the Western diet is high in sugar and dairy,” Dr. Shi said at the ODAC Dermatology, Aesthetic & Surgical Conference.
Dairy, red meat, and carbohydrates can break down into leucine, an essential amino acid found in protein. Leucine and sugar together, in turn, can produce insulin and insulin-like growth factor 1 (IGF-1), which, through different pathways, can reach the androgen receptors throughout the body, including the skin. This results in sebogenesis, lipogenesis, and keratinization, which triggers follicular inflammation and results in more of the acne-causing bacteria Cutibacterium acnes. 
Milk and other dairy products also can increase IGF-1 levels, which can alter hormonal mediators and increase acne.
Not all types of dairy milk are created equal, however, when it comes to acne. Dr. Shi wondered why 2% milk has overall color and nutritional content very similar to that of whole milk. “I looked into this.” She discovered that when milk manufacturers remove the fat, they often add whey proteins to restore some nutrients. Whey protein can increase acne, Dr. Shi added. 
“So, if you’re going to choose any milk to drink, I think from an acne perspective, it’s better to use whole milk. If you can get it organic, even better.” Skim milk is the most acnegenic, she said.

Psoriasis

A systematic review of 55 studies evaluating diet and psoriasis found obesity can be an exacerbating factor. The strongest evidence for dietary weight reduction points to a hypocaloric diet in people with overweight or obesity, according to the review. Other evidence suggests alcohol can lower response to treatment and is linked with more severe psoriasis. Furthermore, a gluten-free diet or vitamin D supplements can help some subpopulations of people with psoriasis. 
“An overwhelming majority of our psoriasis patients are vitamin D deficient,” Dr. Shi said. 
The National Psoriasis Foundation (NPF) publishes dietary modification guidelines, updated as recently as November 2023. The NPF states that “there is no diet that will cure psoriatic disease, but there are many ways in which eating healthful food may lessen the severity of symptoms and play a role in lowering the likelihood of developing comorbidities.”
Healthier choices include fruits, vegetables, whole grains, and fat-free or low-fat dairy products. Include lean meats, poultry, fish, beans, eggs, and nuts. Adherence to a Mediterranean diet has been linked to a lower severity of psoriasis.

Atopic Dermatitis

Atopic dermatitis (AD) is “one of the prototypical diseases related to diet,” Dr. Shi said. A different meta-analysis looked at randomized controlled trials of synbiotics (a combination of prebiotics and probiotics) for treatment of AD.
These researchers found that synbiotics do not prevent AD, but they can help treat it in adults and children older than 1 year. In addition, synbiotics are more beneficial than probiotics in treating the condition, although there are no head-to-head comparison studies. In addition, the meta-analysis found that prebiotics alone can lower AD severity.
However, Dr. Shi said, there are no recommendations from the American Academy of Dermatology (AAD) on prebiotics or probiotics for AD, and the AAD does not recommend any supplement or essential oil for AD.
In a 2022 review, investigators ranked the efficacy of different supplements for AD based on available evidence. They found the greatest benefit associated with vitamin D supplementation, followed by vitamin E, probiotics, hemp seed oil, histidine, and oolong tea. They also noted the ‘Six Food Elimination Diet and Autoimmune Protocol’ featured the least amount of evidence to back it up. 

Rosacea

Rosacea appears to be caused by “all the fun things in life” like sunlight, alcohol, chocolate, spicy foods, and caffeine, Dr. Shi said. In people with rosacea, they can cause facial flushing, edema, burning, and an inflammatory response.
Certain foods can activate skin receptors and sensory neurons, which can release neuropeptides that act on mast cells in blood that lead to flushing. The skin-gut axis may also be involved, evidence suggests. “And that is why food has a pretty profound impact on rosacea,” Dr. Shi said. 
Dr. Shi reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

A clinic aimed at managing patients with difficult-to-control atopic dermatitis (AD) by involving assessments from a team of clinicians from different disciplines led to significant improvements in severity of the disease, results from a single-center study showed.

“A significant challenge in caring for patients with atopic dermatitis is lack of collaboration between healthcare providers, leading to disjointed care, inconsistent treatment plans, and conflicting dialogue with patients,” first author Alexis Tracy, MD, a combined allergy and dermatology research fellow at Rady Children’s Hospital, San Diego, and colleagues wrote in the study, which was published online January 14, 2024, in Pediatric Dermatology.

Launched in 2019, the clinic, which is called the Multidisciplinary Atopic Dermatitis Program (MADP), is a collaborative effort between with Rady Children’s Hospital and the University of California San Diego Health division of dermatology, division of allergy & immunology, and the hospital’s clinical pharmacy. Patients referred to the MADP undergo a concurrent, comprehensive evaluation by a dermatologist, allergist, clinical pharmacist, and others who help to assess AD severity, provide family education about the disease, and form a care plan using the model of shared decision-making (SDM). Visits take about two hours, and the frequency of follow-up visits varies.

Courtesy Rady Children&#039;s Hospital

In the dermatology realm, tools used to compare the extent and severity of AD between visits include the Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), the Children’s Dermatology Life Quality Index (CDLQI), Validated Investigator Global Assessment (vIGA), Body Surface Area (BSA), and the Numerical Rating Scale (NRS).To investigate the MADP’s success to date, Dr. Tracy and colleagues evaluated 44 patients with a history of moderate to severe, persistent AD who were referred to the clinic between April 3, 2019, and October 22, 2022, and had between one and three follow-up visits. The patients ranged from age 4 months to 18 years (mean, 7.74 years).

Compared with baseline, EASI scores of patients decreased significantly, with an average mean improvement of 9.61 by the second visit, 15.12 by the third visit, and 17.42 by the fourth visit (P <.001 for all three). These represent an average decreases of 44.20%, 63.26%, 74.35%, respectively.

At the seventh visit, the EASI score decreased by a mean of 33.48 (P = .008), which represents an average decrease of 91.52% from baseline. Of the 44 patients, 32 achieved an EASI 50 and 21 achieved an EASI 75.

In other findings, the mean vIGA improved with each visit, with the largest observed improvement at the seventh visit (a mean of 2.25 points; P = .009) and the greatest mean improvement in the POEM score was seen at the sixth visit (a mean of 11.13 points; P < .001). The mean difference in CDLQI scores also increased with each visit, with the largest improvement seen at the sixth visit (an increase of 12 points; P < .001).

Similarly, BSA progressively improved at each clinic visit, from a mean decrease of 16.02% at the second visit to a mean decrease of 56.04% at the seventh visit (P < .001 for both). Meanwhile, the largest mean improvement in pruritus was seen at the sixth visit (a mean of 4.10 points; P = .001).

In an interview, MADP’s codirector, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, said that the consistency of data showing rapid, consistent improvement with a varied set of physician assessed scores and patient-reported outcomes “was very impressive, especially given the variation in severity, extent and difficult course of many of the patients we saw, and spectrum of interventions – from topical regimens to advanced systemic therapies,” he said. “As clinicians we tend to remember the ‘tough cases,’ and it was tremendous to see the impact and utility of the clinic.”

Courtesy University of California, San Diego

Important model of care

Asked to comment on the results, pediatric dermatologist Moise L. Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, who was not involved with the study, characterized the MADP as an important model of care. “Multi-interdisciplinary care of such conditions is well-known to be of great help for patients and their families,” he told this news organization.

“A key part of the ‘team’ is the family/patient engagement and shared decision-making. The use of visual aides to highlight components of care was likely of great use, as well,” he said. “All such interventions impact the disease, as well as associated problems, such as itch, sleep, and mental health. Importantly, such interventions, while known to be useful as demonstrated by the authors, take time, and relate to improved outcomes as noted by the date outlined by the authors.”

The study authors acknowledged certain limitations of the study, including the lack of a control group with single-specialty visits. “The real take-away is that taking the time to do more holistic assessments of health — with skin and allergy issues being discussed, and consistent education and messaging — helps make our medical interventions more successful, with both objective disease improvement and patient/family satisfaction,” Dr. Eichenfield said in the interview.

Pfizer and Sanofi provided financial support to MADP, and for the study. Dr. Eichenfield disclosed that he serves as a scientific adviser, consultant, and/or clinical trial investigator for AbbVie, Amgen, Aslan, Castle Biosciences, Dermavant, Eli Lilly and Company, Forté, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sanofi-Genzyme, Trialspark, and UCB. Dr. Geng disclosed ties with Sanofi, Regeneron, Pfizer, and AbbVie, and is an adviser to Incyte, Galderma, Eli-Lilly, and LEO. The other authors reported having no disclosures. Dr. Levy disclosed ties with Abeona, Amgen, Arcutis, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. He is also an investigator for Janssen.

A clinic aimed at managing patients with difficult-to-control atopic dermatitis (AD) by involving assessments from a team of clinicians from different disciplines led to significant improvements in severity of the disease, results from a single-center study showed.

“A significant challenge in caring for patients with atopic dermatitis is lack of collaboration between healthcare providers, leading to disjointed care, inconsistent treatment plans, and conflicting dialogue with patients,” first author Alexis Tracy, MD, a combined allergy and dermatology research fellow at Rady Children’s Hospital, San Diego, and colleagues wrote in the study, which was published online January 14, 2024, in Pediatric Dermatology.

Launched in 2019, the clinic, which is called the Multidisciplinary Atopic Dermatitis Program (MADP), is a collaborative effort between with Rady Children’s Hospital and the University of California San Diego Health division of dermatology, division of allergy & immunology, and the hospital’s clinical pharmacy. Patients referred to the MADP undergo a concurrent, comprehensive evaluation by a dermatologist, allergist, clinical pharmacist, and others who help to assess AD severity, provide family education about the disease, and form a care plan using the model of shared decision-making (SDM). Visits take about two hours, and the frequency of follow-up visits varies.

Courtesy Rady Children&#039;s Hospital

In the dermatology realm, tools used to compare the extent and severity of AD between visits include the Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), the Children’s Dermatology Life Quality Index (CDLQI), Validated Investigator Global Assessment (vIGA), Body Surface Area (BSA), and the Numerical Rating Scale (NRS).To investigate the MADP’s success to date, Dr. Tracy and colleagues evaluated 44 patients with a history of moderate to severe, persistent AD who were referred to the clinic between April 3, 2019, and October 22, 2022, and had between one and three follow-up visits. The patients ranged from age 4 months to 18 years (mean, 7.74 years).

Compared with baseline, EASI scores of patients decreased significantly, with an average mean improvement of 9.61 by the second visit, 15.12 by the third visit, and 17.42 by the fourth visit (P <.001 for all three). These represent an average decreases of 44.20%, 63.26%, 74.35%, respectively.

At the seventh visit, the EASI score decreased by a mean of 33.48 (P = .008), which represents an average decrease of 91.52% from baseline. Of the 44 patients, 32 achieved an EASI 50 and 21 achieved an EASI 75.

In other findings, the mean vIGA improved with each visit, with the largest observed improvement at the seventh visit (a mean of 2.25 points; P = .009) and the greatest mean improvement in the POEM score was seen at the sixth visit (a mean of 11.13 points; P < .001). The mean difference in CDLQI scores also increased with each visit, with the largest improvement seen at the sixth visit (an increase of 12 points; P < .001).

Similarly, BSA progressively improved at each clinic visit, from a mean decrease of 16.02% at the second visit to a mean decrease of 56.04% at the seventh visit (P < .001 for both). Meanwhile, the largest mean improvement in pruritus was seen at the sixth visit (a mean of 4.10 points; P = .001).

In an interview, MADP’s codirector, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, said that the consistency of data showing rapid, consistent improvement with a varied set of physician assessed scores and patient-reported outcomes “was very impressive, especially given the variation in severity, extent and difficult course of many of the patients we saw, and spectrum of interventions – from topical regimens to advanced systemic therapies,” he said. “As clinicians we tend to remember the ‘tough cases,’ and it was tremendous to see the impact and utility of the clinic.”

Courtesy University of California, San Diego

Important model of care

Asked to comment on the results, pediatric dermatologist Moise L. Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, who was not involved with the study, characterized the MADP as an important model of care. “Multi-interdisciplinary care of such conditions is well-known to be of great help for patients and their families,” he told this news organization.

“A key part of the ‘team’ is the family/patient engagement and shared decision-making. The use of visual aides to highlight components of care was likely of great use, as well,” he said. “All such interventions impact the disease, as well as associated problems, such as itch, sleep, and mental health. Importantly, such interventions, while known to be useful as demonstrated by the authors, take time, and relate to improved outcomes as noted by the date outlined by the authors.”

The study authors acknowledged certain limitations of the study, including the lack of a control group with single-specialty visits. “The real take-away is that taking the time to do more holistic assessments of health — with skin and allergy issues being discussed, and consistent education and messaging — helps make our medical interventions more successful, with both objective disease improvement and patient/family satisfaction,” Dr. Eichenfield said in the interview.

Pfizer and Sanofi provided financial support to MADP, and for the study. Dr. Eichenfield disclosed that he serves as a scientific adviser, consultant, and/or clinical trial investigator for AbbVie, Amgen, Aslan, Castle Biosciences, Dermavant, Eli Lilly and Company, Forté, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sanofi-Genzyme, Trialspark, and UCB. Dr. Geng disclosed ties with Sanofi, Regeneron, Pfizer, and AbbVie, and is an adviser to Incyte, Galderma, Eli-Lilly, and LEO. The other authors reported having no disclosures. Dr. Levy disclosed ties with Abeona, Amgen, Arcutis, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. He is also an investigator for Janssen.

A clinic aimed at managing patients with difficult-to-control atopic dermatitis (AD) by involving assessments from a team of clinicians from different disciplines led to significant improvements in severity of the disease, results from a single-center study showed.

“A significant challenge in caring for patients with atopic dermatitis is lack of collaboration between healthcare providers, leading to disjointed care, inconsistent treatment plans, and conflicting dialogue with patients,” first author Alexis Tracy, MD, a combined allergy and dermatology research fellow at Rady Children’s Hospital, San Diego, and colleagues wrote in the study, which was published online January 14, 2024, in Pediatric Dermatology.

Launched in 2019, the clinic, which is called the Multidisciplinary Atopic Dermatitis Program (MADP), is a collaborative effort between with Rady Children’s Hospital and the University of California San Diego Health division of dermatology, division of allergy & immunology, and the hospital’s clinical pharmacy. Patients referred to the MADP undergo a concurrent, comprehensive evaluation by a dermatologist, allergist, clinical pharmacist, and others who help to assess AD severity, provide family education about the disease, and form a care plan using the model of shared decision-making (SDM). Visits take about two hours, and the frequency of follow-up visits varies.

Courtesy Rady Children&#039;s Hospital

In the dermatology realm, tools used to compare the extent and severity of AD between visits include the Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), the Children’s Dermatology Life Quality Index (CDLQI), Validated Investigator Global Assessment (vIGA), Body Surface Area (BSA), and the Numerical Rating Scale (NRS).To investigate the MADP’s success to date, Dr. Tracy and colleagues evaluated 44 patients with a history of moderate to severe, persistent AD who were referred to the clinic between April 3, 2019, and October 22, 2022, and had between one and three follow-up visits. The patients ranged from age 4 months to 18 years (mean, 7.74 years).

Compared with baseline, EASI scores of patients decreased significantly, with an average mean improvement of 9.61 by the second visit, 15.12 by the third visit, and 17.42 by the fourth visit (P <.001 for all three). These represent an average decreases of 44.20%, 63.26%, 74.35%, respectively.

At the seventh visit, the EASI score decreased by a mean of 33.48 (P = .008), which represents an average decrease of 91.52% from baseline. Of the 44 patients, 32 achieved an EASI 50 and 21 achieved an EASI 75.

In other findings, the mean vIGA improved with each visit, with the largest observed improvement at the seventh visit (a mean of 2.25 points; P = .009) and the greatest mean improvement in the POEM score was seen at the sixth visit (a mean of 11.13 points; P < .001). The mean difference in CDLQI scores also increased with each visit, with the largest improvement seen at the sixth visit (an increase of 12 points; P < .001).

Similarly, BSA progressively improved at each clinic visit, from a mean decrease of 16.02% at the second visit to a mean decrease of 56.04% at the seventh visit (P < .001 for both). Meanwhile, the largest mean improvement in pruritus was seen at the sixth visit (a mean of 4.10 points; P = .001).

In an interview, MADP’s codirector, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, said that the consistency of data showing rapid, consistent improvement with a varied set of physician assessed scores and patient-reported outcomes “was very impressive, especially given the variation in severity, extent and difficult course of many of the patients we saw, and spectrum of interventions – from topical regimens to advanced systemic therapies,” he said. “As clinicians we tend to remember the ‘tough cases,’ and it was tremendous to see the impact and utility of the clinic.”

Courtesy University of California, San Diego

Important model of care

Asked to comment on the results, pediatric dermatologist Moise L. Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, who was not involved with the study, characterized the MADP as an important model of care. “Multi-interdisciplinary care of such conditions is well-known to be of great help for patients and their families,” he told this news organization.

“A key part of the ‘team’ is the family/patient engagement and shared decision-making. The use of visual aides to highlight components of care was likely of great use, as well,” he said. “All such interventions impact the disease, as well as associated problems, such as itch, sleep, and mental health. Importantly, such interventions, while known to be useful as demonstrated by the authors, take time, and relate to improved outcomes as noted by the date outlined by the authors.”

The study authors acknowledged certain limitations of the study, including the lack of a control group with single-specialty visits. “The real take-away is that taking the time to do more holistic assessments of health — with skin and allergy issues being discussed, and consistent education and messaging — helps make our medical interventions more successful, with both objective disease improvement and patient/family satisfaction,” Dr. Eichenfield said in the interview.

Pfizer and Sanofi provided financial support to MADP, and for the study. Dr. Eichenfield disclosed that he serves as a scientific adviser, consultant, and/or clinical trial investigator for AbbVie, Amgen, Aslan, Castle Biosciences, Dermavant, Eli Lilly and Company, Forté, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sanofi-Genzyme, Trialspark, and UCB. Dr. Geng disclosed ties with Sanofi, Regeneron, Pfizer, and AbbVie, and is an adviser to Incyte, Galderma, Eli-Lilly, and LEO. The other authors reported having no disclosures. Dr. Levy disclosed ties with Abeona, Amgen, Arcutis, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. He is also an investigator for Janssen.

Men who have smoked or currently smoke are significantly more likely to develop androgenetic alopecia (AGA) than men who have never smoked, according to a new study.

In addition, the odds of developing AGA are higher among those who smoke at least 10 cigarettes per day than among those who smoke less, the study authors found.

“Men who smoke are more likely to develop and experience progression of male pattern hair loss,” lead author Aditya Gupta, MD, PhD, professor of medicine at the University of Toronto, Toronto, and director of clinical research at Mediprobe Research Inc., London, Ontario, Canada, told this news organization.

“Our patients with male pattern baldness need to be educated about the negative effects of smoking, given that this condition can have a profound negative psychological impact on those who suffer from it,” he said.

The study was published online in the Journal of Cosmetic Dermatology.
 

Analyzing Smoking’s Effects

Smoking generally has been accepted as a risk factor for the development and progression of AGA or the most common form of hair loss. The research evidence on this association has been inconsistent, however, the authors wrote.

The investigators conducted a review and meta-analysis of eight observational studies to understand the links between smoking and AGA. Ever-smokers were defined as current and former smokers.

Overall, based on six studies, men who have ever smoked are 1.8 times more likely (P < .05) to develop AGA.

Based on two studies, men who smoke 10 or more cigarettes daily are about twice as likely (P < .05) to develop AGA than those who smoke up to 10 cigarettes per day.

Based on four studies, ever smoking is associated with 1.3 times higher odds of AGA progressing from mild (ie, Norwood-Hamilton stages I-III) to more severe (stages IV-VII) than among those who have never smoked.

Based on two studies, there’s no association between AGA progression and smoking intensity (as defined as smoking up to 20 cigarettes daily vs smoking 20 or more cigarettes per day).

“Though our pooled analysis found no significant association between smoking intensity and severity of male AGA, a positive correlation may exist and be detected through an analysis that is statistically better powered,” said Dr. Gupta.

The investigators noted the limitations of their analysis, such as its reliance on observational studies and its lack of data about nicotine levels, smoking intensity, and smoking cessation among study participants.

Additional studies are needed to better understand the links between smoking and hair loss, said Dr. Gupta, as well as the effects of smoking cessation.

Improving Practice and Research

Commenting on the findings for this news organization, Arash Babadjouni, MD, a dermatologist at Midwestern University, Glendale, Arizona, said, “Smoking is not only a preventable cause of significant systemic disease but also affects the follicular growth cycle and fiber pigmentation. The prevalence of hair loss and premature hair graying is higher in smokers than nonsmokers.”

Dr. Babadjouni, who wasn’t involved with this study, has researched the associations between smoking and hair loss and premature hair graying.

“Evidence of this association can be used to clinically promote smoking cessation and emphasize the consequences of smoking on hair,” he said. “Smoking status should be assessed in patients who are presenting to their dermatologist and physicians alike for evaluation of alopecia and premature hair graying.”

The study was conducted without outside funding, and the authors declared no conflicts of interest. Dr. Babadjouni reported no relevant disclosures.

A version of this article appeared on Medscape.com.

Men who have smoked or currently smoke are significantly more likely to develop androgenetic alopecia (AGA) than men who have never smoked, according to a new study.

In addition, the odds of developing AGA are higher among those who smoke at least 10 cigarettes per day than among those who smoke less, the study authors found.

“Men who smoke are more likely to develop and experience progression of male pattern hair loss,” lead author Aditya Gupta, MD, PhD, professor of medicine at the University of Toronto, Toronto, and director of clinical research at Mediprobe Research Inc., London, Ontario, Canada, told this news organization.

“Our patients with male pattern baldness need to be educated about the negative effects of smoking, given that this condition can have a profound negative psychological impact on those who suffer from it,” he said.

The study was published online in the Journal of Cosmetic Dermatology.
 

Analyzing Smoking’s Effects

Smoking generally has been accepted as a risk factor for the development and progression of AGA or the most common form of hair loss. The research evidence on this association has been inconsistent, however, the authors wrote.

The investigators conducted a review and meta-analysis of eight observational studies to understand the links between smoking and AGA. Ever-smokers were defined as current and former smokers.

Overall, based on six studies, men who have ever smoked are 1.8 times more likely (P < .05) to develop AGA.

Based on two studies, men who smoke 10 or more cigarettes daily are about twice as likely (P < .05) to develop AGA than those who smoke up to 10 cigarettes per day.

Based on four studies, ever smoking is associated with 1.3 times higher odds of AGA progressing from mild (ie, Norwood-Hamilton stages I-III) to more severe (stages IV-VII) than among those who have never smoked.

Based on two studies, there’s no association between AGA progression and smoking intensity (as defined as smoking up to 20 cigarettes daily vs smoking 20 or more cigarettes per day).

“Though our pooled analysis found no significant association between smoking intensity and severity of male AGA, a positive correlation may exist and be detected through an analysis that is statistically better powered,” said Dr. Gupta.

The investigators noted the limitations of their analysis, such as its reliance on observational studies and its lack of data about nicotine levels, smoking intensity, and smoking cessation among study participants.

Additional studies are needed to better understand the links between smoking and hair loss, said Dr. Gupta, as well as the effects of smoking cessation.

Improving Practice and Research

Commenting on the findings for this news organization, Arash Babadjouni, MD, a dermatologist at Midwestern University, Glendale, Arizona, said, “Smoking is not only a preventable cause of significant systemic disease but also affects the follicular growth cycle and fiber pigmentation. The prevalence of hair loss and premature hair graying is higher in smokers than nonsmokers.”

Dr. Babadjouni, who wasn’t involved with this study, has researched the associations between smoking and hair loss and premature hair graying.

“Evidence of this association can be used to clinically promote smoking cessation and emphasize the consequences of smoking on hair,” he said. “Smoking status should be assessed in patients who are presenting to their dermatologist and physicians alike for evaluation of alopecia and premature hair graying.”

The study was conducted without outside funding, and the authors declared no conflicts of interest. Dr. Babadjouni reported no relevant disclosures.

A version of this article appeared on Medscape.com.

Men who have smoked or currently smoke are significantly more likely to develop androgenetic alopecia (AGA) than men who have never smoked, according to a new study.

In addition, the odds of developing AGA are higher among those who smoke at least 10 cigarettes per day than among those who smoke less, the study authors found.

“Men who smoke are more likely to develop and experience progression of male pattern hair loss,” lead author Aditya Gupta, MD, PhD, professor of medicine at the University of Toronto, Toronto, and director of clinical research at Mediprobe Research Inc., London, Ontario, Canada, told this news organization.

“Our patients with male pattern baldness need to be educated about the negative effects of smoking, given that this condition can have a profound negative psychological impact on those who suffer from it,” he said.

The study was published online in the Journal of Cosmetic Dermatology.
 

Analyzing Smoking’s Effects

Smoking generally has been accepted as a risk factor for the development and progression of AGA or the most common form of hair loss. The research evidence on this association has been inconsistent, however, the authors wrote.

The investigators conducted a review and meta-analysis of eight observational studies to understand the links between smoking and AGA. Ever-smokers were defined as current and former smokers.

Overall, based on six studies, men who have ever smoked are 1.8 times more likely (P < .05) to develop AGA.

Based on two studies, men who smoke 10 or more cigarettes daily are about twice as likely (P < .05) to develop AGA than those who smoke up to 10 cigarettes per day.

Based on four studies, ever smoking is associated with 1.3 times higher odds of AGA progressing from mild (ie, Norwood-Hamilton stages I-III) to more severe (stages IV-VII) than among those who have never smoked.

Based on two studies, there’s no association between AGA progression and smoking intensity (as defined as smoking up to 20 cigarettes daily vs smoking 20 or more cigarettes per day).

“Though our pooled analysis found no significant association between smoking intensity and severity of male AGA, a positive correlation may exist and be detected through an analysis that is statistically better powered,” said Dr. Gupta.

The investigators noted the limitations of their analysis, such as its reliance on observational studies and its lack of data about nicotine levels, smoking intensity, and smoking cessation among study participants.

Additional studies are needed to better understand the links between smoking and hair loss, said Dr. Gupta, as well as the effects of smoking cessation.

Improving Practice and Research

Commenting on the findings for this news organization, Arash Babadjouni, MD, a dermatologist at Midwestern University, Glendale, Arizona, said, “Smoking is not only a preventable cause of significant systemic disease but also affects the follicular growth cycle and fiber pigmentation. The prevalence of hair loss and premature hair graying is higher in smokers than nonsmokers.”

Dr. Babadjouni, who wasn’t involved with this study, has researched the associations between smoking and hair loss and premature hair graying.

“Evidence of this association can be used to clinically promote smoking cessation and emphasize the consequences of smoking on hair,” he said. “Smoking status should be assessed in patients who are presenting to their dermatologist and physicians alike for evaluation of alopecia and premature hair graying.”

The study was conducted without outside funding, and the authors declared no conflicts of interest. Dr. Babadjouni reported no relevant disclosures.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has cleared the DermaSensor device for point-of-care, noninvasive testing for all types of skin cancer.

The handheld wireless tool, which was developed by Miami-based DermaSensor Inc., operates on battery power, uses spectroscopy and algorithms to evaluate skin lesions for potential cancer in a matter of seconds, and is intended for use by primary care physicians. After the device completes the scan of a lesion, a result of “investigate further” (positive result) suggests further evaluation through a referral to a dermatologist, while “monitor” (negative result) suggests that there is no immediate need for a referral to a dermatologist.

In a pivotal trial of the device that evaluated 224 high risk lesions at 18 primary care study sites in the United States and 4 in Australia, the device had an overall sensitivity of 95.5% for detecting malignancy.

In a more recent validation study funded by DermaSensor, investigators tested 333 lesions at four U.S. dermatology offices and found that the overall device sensitivity was 97.04%, with subgroup sensitivity of 96.67% for melanoma, 97.22% for basal cell carcinoma, and 97.01% for squamous cell carcinoma. Overall specificity of the device was 26.22%.

The study authors, led by Tallahassee, Fla.–based dermatologist Armand B. Cognetta Jr., MD, concluded that DermaSensor’s rapid clinical analysis of lesions “allows for its easy integration into clinical practice infrastructures. Proper use of this device may aid in the reduction of morbidity and mortality associated with skin cancer through expedited and enhanced detection and intervention.”

According to marketing material from the DermaSensor website, the device’s AI algorithm was developed and validated with more than 20,000 scans, composed of more than 4,000 benign and malignant lesions. In a statement about the clearance, the FDA emphasized that the device “should not be used as the sole diagnostic criterion nor to confirm a diagnosis of skin cancer.” The agency is requiring that the manufacturer “conduct additional post-market clinical validation performance testing of the DermaSensor device in patients from demographic groups representative of the U.S. population, including populations who had limited representation of melanomas in the premarket studies, due to their having a relatively low incidence of the disease.”

According to a spokesperson for DermaSensor, pricing for the device is based on a subscription model: $199 per month for five patients or $399 per month for unlimited use. DermaSensor is currently commercially available in Europe and Australia.

Asked to comment, Vishal A. Patel, MD, director of cutaneous oncology at the George Washington Cancer Center, Washington, said that the FDA clearance of DermaSensor highlights the growing appreciation of AI-driven diagnostic support for primary care providers and dermatologists. "Skin cancers are a growing epidemic in the US and the ability to accurately identify potential suspicious lesions without immediately reaching for the scalpel is invaluable," Patel told this news organization. He was not involved with DermSensor studies.

"Furthermore, this tool can help address the shortage of dermatologists and long wait times by helping primary care providers accurately risk-stratify patients and identify those who need to be seen immediately for potential biopsy and expert care," he added. "However, just like with any new technology, we must use caution to not overutilize this tool," which he said, could "lead to overdiagnosis and overtreatment of early or innocuous lesions that are better managed with empiric field treatments." 

Dr. Cognetta was a paid investigator for the study.

Dr. Patel disclosed that he is chief medical officer for Lazarus AI.

The Food and Drug Administration has cleared the DermaSensor device for point-of-care, noninvasive testing for all types of skin cancer.

The handheld wireless tool, which was developed by Miami-based DermaSensor Inc., operates on battery power, uses spectroscopy and algorithms to evaluate skin lesions for potential cancer in a matter of seconds, and is intended for use by primary care physicians. After the device completes the scan of a lesion, a result of “investigate further” (positive result) suggests further evaluation through a referral to a dermatologist, while “monitor” (negative result) suggests that there is no immediate need for a referral to a dermatologist.

In a pivotal trial of the device that evaluated 224 high risk lesions at 18 primary care study sites in the United States and 4 in Australia, the device had an overall sensitivity of 95.5% for detecting malignancy.

In a more recent validation study funded by DermaSensor, investigators tested 333 lesions at four U.S. dermatology offices and found that the overall device sensitivity was 97.04%, with subgroup sensitivity of 96.67% for melanoma, 97.22% for basal cell carcinoma, and 97.01% for squamous cell carcinoma. Overall specificity of the device was 26.22%.

The study authors, led by Tallahassee, Fla.–based dermatologist Armand B. Cognetta Jr., MD, concluded that DermaSensor’s rapid clinical analysis of lesions “allows for its easy integration into clinical practice infrastructures. Proper use of this device may aid in the reduction of morbidity and mortality associated with skin cancer through expedited and enhanced detection and intervention.”

According to marketing material from the DermaSensor website, the device’s AI algorithm was developed and validated with more than 20,000 scans, composed of more than 4,000 benign and malignant lesions. In a statement about the clearance, the FDA emphasized that the device “should not be used as the sole diagnostic criterion nor to confirm a diagnosis of skin cancer.” The agency is requiring that the manufacturer “conduct additional post-market clinical validation performance testing of the DermaSensor device in patients from demographic groups representative of the U.S. population, including populations who had limited representation of melanomas in the premarket studies, due to their having a relatively low incidence of the disease.”

According to a spokesperson for DermaSensor, pricing for the device is based on a subscription model: $199 per month for five patients or $399 per month for unlimited use. DermaSensor is currently commercially available in Europe and Australia.

Asked to comment, Vishal A. Patel, MD, director of cutaneous oncology at the George Washington Cancer Center, Washington, said that the FDA clearance of DermaSensor highlights the growing appreciation of AI-driven diagnostic support for primary care providers and dermatologists. "Skin cancers are a growing epidemic in the US and the ability to accurately identify potential suspicious lesions without immediately reaching for the scalpel is invaluable," Patel told this news organization. He was not involved with DermSensor studies.

"Furthermore, this tool can help address the shortage of dermatologists and long wait times by helping primary care providers accurately risk-stratify patients and identify those who need to be seen immediately for potential biopsy and expert care," he added. "However, just like with any new technology, we must use caution to not overutilize this tool," which he said, could "lead to overdiagnosis and overtreatment of early or innocuous lesions that are better managed with empiric field treatments." 

Dr. Cognetta was a paid investigator for the study.

Dr. Patel disclosed that he is chief medical officer for Lazarus AI.

The Food and Drug Administration has cleared the DermaSensor device for point-of-care, noninvasive testing for all types of skin cancer.

The handheld wireless tool, which was developed by Miami-based DermaSensor Inc., operates on battery power, uses spectroscopy and algorithms to evaluate skin lesions for potential cancer in a matter of seconds, and is intended for use by primary care physicians. After the device completes the scan of a lesion, a result of “investigate further” (positive result) suggests further evaluation through a referral to a dermatologist, while “monitor” (negative result) suggests that there is no immediate need for a referral to a dermatologist.

In a pivotal trial of the device that evaluated 224 high risk lesions at 18 primary care study sites in the United States and 4 in Australia, the device had an overall sensitivity of 95.5% for detecting malignancy.

In a more recent validation study funded by DermaSensor, investigators tested 333 lesions at four U.S. dermatology offices and found that the overall device sensitivity was 97.04%, with subgroup sensitivity of 96.67% for melanoma, 97.22% for basal cell carcinoma, and 97.01% for squamous cell carcinoma. Overall specificity of the device was 26.22%.

The study authors, led by Tallahassee, Fla.–based dermatologist Armand B. Cognetta Jr., MD, concluded that DermaSensor’s rapid clinical analysis of lesions “allows for its easy integration into clinical practice infrastructures. Proper use of this device may aid in the reduction of morbidity and mortality associated with skin cancer through expedited and enhanced detection and intervention.”

According to marketing material from the DermaSensor website, the device’s AI algorithm was developed and validated with more than 20,000 scans, composed of more than 4,000 benign and malignant lesions. In a statement about the clearance, the FDA emphasized that the device “should not be used as the sole diagnostic criterion nor to confirm a diagnosis of skin cancer.” The agency is requiring that the manufacturer “conduct additional post-market clinical validation performance testing of the DermaSensor device in patients from demographic groups representative of the U.S. population, including populations who had limited representation of melanomas in the premarket studies, due to their having a relatively low incidence of the disease.”

According to a spokesperson for DermaSensor, pricing for the device is based on a subscription model: $199 per month for five patients or $399 per month for unlimited use. DermaSensor is currently commercially available in Europe and Australia.

Asked to comment, Vishal A. Patel, MD, director of cutaneous oncology at the George Washington Cancer Center, Washington, said that the FDA clearance of DermaSensor highlights the growing appreciation of AI-driven diagnostic support for primary care providers and dermatologists. "Skin cancers are a growing epidemic in the US and the ability to accurately identify potential suspicious lesions without immediately reaching for the scalpel is invaluable," Patel told this news organization. He was not involved with DermSensor studies.

"Furthermore, this tool can help address the shortage of dermatologists and long wait times by helping primary care providers accurately risk-stratify patients and identify those who need to be seen immediately for potential biopsy and expert care," he added. "However, just like with any new technology, we must use caution to not overutilize this tool," which he said, could "lead to overdiagnosis and overtreatment of early or innocuous lesions that are better managed with empiric field treatments." 

Dr. Cognetta was a paid investigator for the study.

Dr. Patel disclosed that he is chief medical officer for Lazarus AI.