Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.

Phase 3 prurigo nodularis trial shows positive results for nemolizumab

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Changed
Wed, 03/22/2023 - 12:30

Nemolizumab monotherapy for 16 weeks improved itch, skin lesions, and sleep disturbances in adults with prurigo nodularis (PN), results from a phase 3 trial demonstrated.

Nemolizumab is a first-in-class investigational monoclonal antibody directed against the interleukin-31 receptor alpha that blocks signaling from IL-31. “From prior studies we know that it modulates pruritus, but also alters keratinocyte differentiation, inflammation, and fibrosis,” one of the investigators, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said during a late-breaking research session at the annual meeting of the American Academy of Dermatology.

Dr. Sean Kwatra

OLYMPIA 2 was a phase 3, multicenter, double-blind study in adults with PN presenting with 20 or more nodules, and Investigator’s Global Assessment (IGA) score of 3 or more, and the Peak Pruritus Numerical Rating Scale (PP-NRS) score of 7 or more. Exclusion criteria included chronic pruritus resulting from an active condition other than PN, such as neuropathic and psychogenic pruritus and active atopic dermatitis. In addition, the use of topical steroids, considered a rescue therapy, was not allowed in the trial, Dr. Kwatra said.

After an initial screening period, 274 patients at 73 sites in nine countries were randomized 2:1 either to the nemolizumab monotherapy or placebo. Following an initial 60-mg subcutaneous dose, patients received 30 mg or 60 mg (depending on their baseline weight) every 4 weeks for 16 weeks. The primary endpoint was the proportion of patients with a 4-point or greater improvement in the PP-NRS from baseline at week 16 and the proportion of patients with IGA success at week 16.

Selected key secondary endpoints included the proportion of patients with a 4 point or greater improvement from baseline in the PP-NRS at week 4, the Sleep Disturbance Numerical Rating Scale at week 4, and the SD-NRS at week 16. Safety endpoints included the incidence and severity of all adverse events.

Of the 274 patients randomized, 183 received nemolizumab and 91 received placebo. A total of 174 patients in the nemolizumab group completed the study, compared with 88 in the placebo group. The mean age of study participants was 53 years, 61% were women, 79% were White, 14% were Asian, and the rest were from other racial groups. More than half (57%) had IGA category 3 disease (moderate) and the remainder had IGA category 4 disease (severe); 63% had 20-100 lesions, and the remainder had more than 100. About one-third of study enrollees (32%) had a history of atopy.
 

Primary, secondary endpoint results

Dr. Kwatra reported that 56.3% of the patients in the nemolizumab group achieved a 4-point or greater improvement in the PP-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001), while 37.7% of those in the nemolizumab group achieved IGA success at week 16, compared with 11% of those in the placebo group (P < .0001).

As for secondary endpoints, 41% of patients in the nemolizumab group achieved a 4-point or greater improvement in PP-NRS at week 4, compared with 7.7% of those in the placebo group (P < .0001); and 37.2% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 4, compared with 9.9% of those in the placebo group (P < .0001). Almost 52% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001); and 9.8% of those in the nemolizumab group achieved IGA success at week 4, compared with 1.1% of those in the placebo group (P < .0074).
 

 

 

Adverse events

Treatment-emergent adverse events occurred in 61.2% of subjects in the nemolizumab group, compared with 52.7% of those in the placebo group. “There were no imbalances overall, [including] no injection-related reactions in either group,” Dr. Kwatra said. There was one case of newly diagnosed asthma in the placebo arm, and none in the treatment arm.

The researchers observed a slightly increased onset of atopic dermatitis in the treatment arm, compared with the placebo arm (5.5% vs. 0%). “Seven out of those 10 patients actually had a history of atopic dermatitis or high IgE [levels] and they were mostly managed with topical steroids without study drug discontinuation,” Dr. Kwatra added. Neurodermatitis, or worsening of PN, occurred in 3.8% of patients in the nemolizumab group, compared with 11% of those in the placebo group.

“The results of this study extend the efficacy and safety findings from the phase 2 study of nemolizumab in patients with PN,” Dr. Kwatra concluded. “I think they also help to usher in a new era of PN [treatment] in prime time.”



Kenneth B. Gordon, MD, who chairs the department of dermatology at the Medical College of Wisconsin, Milwaukee, and was asked to comment on the study, was impressed with nemolizumab’s propensity for blocking IL-31. “To be able to treat PN effectively by simply blocking the itch and not having a significant inflammatory function is really interesting,” he said in an interview at the meeting. If approved, nemolizumab “gives us another treatment option for a disease that is really debilitating. It’s very promising and we hope [the drug] will be available to us in the near future.”

Nemolizumab is being developed by Galderma. According to a press release from the company, nemolizumab was granted Breakthrough Therapy designation by the Food and Drug Administration in December 2019 for the treatment of pruritus associated with PN, a status that was reconfirmed in February 2023.

Dr. Kwatra disclosed that he is an advisory board member/consultant for Galderma, AbbVie, Amgen, Arcutis, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex, Incyte, Johnson and Johnson, Leo Pharma, Novartis, Pfizer, Regeneron, and Sanofi. Dr. Gordon disclosed that he is a consultant to, an investigator for, and/or a member of the advisory board for several pharmaceutical companies, but not Galderma.

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Nemolizumab monotherapy for 16 weeks improved itch, skin lesions, and sleep disturbances in adults with prurigo nodularis (PN), results from a phase 3 trial demonstrated.

Nemolizumab is a first-in-class investigational monoclonal antibody directed against the interleukin-31 receptor alpha that blocks signaling from IL-31. “From prior studies we know that it modulates pruritus, but also alters keratinocyte differentiation, inflammation, and fibrosis,” one of the investigators, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said during a late-breaking research session at the annual meeting of the American Academy of Dermatology.

Dr. Sean Kwatra

OLYMPIA 2 was a phase 3, multicenter, double-blind study in adults with PN presenting with 20 or more nodules, and Investigator’s Global Assessment (IGA) score of 3 or more, and the Peak Pruritus Numerical Rating Scale (PP-NRS) score of 7 or more. Exclusion criteria included chronic pruritus resulting from an active condition other than PN, such as neuropathic and psychogenic pruritus and active atopic dermatitis. In addition, the use of topical steroids, considered a rescue therapy, was not allowed in the trial, Dr. Kwatra said.

After an initial screening period, 274 patients at 73 sites in nine countries were randomized 2:1 either to the nemolizumab monotherapy or placebo. Following an initial 60-mg subcutaneous dose, patients received 30 mg or 60 mg (depending on their baseline weight) every 4 weeks for 16 weeks. The primary endpoint was the proportion of patients with a 4-point or greater improvement in the PP-NRS from baseline at week 16 and the proportion of patients with IGA success at week 16.

Selected key secondary endpoints included the proportion of patients with a 4 point or greater improvement from baseline in the PP-NRS at week 4, the Sleep Disturbance Numerical Rating Scale at week 4, and the SD-NRS at week 16. Safety endpoints included the incidence and severity of all adverse events.

Of the 274 patients randomized, 183 received nemolizumab and 91 received placebo. A total of 174 patients in the nemolizumab group completed the study, compared with 88 in the placebo group. The mean age of study participants was 53 years, 61% were women, 79% were White, 14% were Asian, and the rest were from other racial groups. More than half (57%) had IGA category 3 disease (moderate) and the remainder had IGA category 4 disease (severe); 63% had 20-100 lesions, and the remainder had more than 100. About one-third of study enrollees (32%) had a history of atopy.
 

Primary, secondary endpoint results

Dr. Kwatra reported that 56.3% of the patients in the nemolizumab group achieved a 4-point or greater improvement in the PP-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001), while 37.7% of those in the nemolizumab group achieved IGA success at week 16, compared with 11% of those in the placebo group (P < .0001).

As for secondary endpoints, 41% of patients in the nemolizumab group achieved a 4-point or greater improvement in PP-NRS at week 4, compared with 7.7% of those in the placebo group (P < .0001); and 37.2% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 4, compared with 9.9% of those in the placebo group (P < .0001). Almost 52% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001); and 9.8% of those in the nemolizumab group achieved IGA success at week 4, compared with 1.1% of those in the placebo group (P < .0074).
 

 

 

Adverse events

Treatment-emergent adverse events occurred in 61.2% of subjects in the nemolizumab group, compared with 52.7% of those in the placebo group. “There were no imbalances overall, [including] no injection-related reactions in either group,” Dr. Kwatra said. There was one case of newly diagnosed asthma in the placebo arm, and none in the treatment arm.

The researchers observed a slightly increased onset of atopic dermatitis in the treatment arm, compared with the placebo arm (5.5% vs. 0%). “Seven out of those 10 patients actually had a history of atopic dermatitis or high IgE [levels] and they were mostly managed with topical steroids without study drug discontinuation,” Dr. Kwatra added. Neurodermatitis, or worsening of PN, occurred in 3.8% of patients in the nemolizumab group, compared with 11% of those in the placebo group.

“The results of this study extend the efficacy and safety findings from the phase 2 study of nemolizumab in patients with PN,” Dr. Kwatra concluded. “I think they also help to usher in a new era of PN [treatment] in prime time.”



Kenneth B. Gordon, MD, who chairs the department of dermatology at the Medical College of Wisconsin, Milwaukee, and was asked to comment on the study, was impressed with nemolizumab’s propensity for blocking IL-31. “To be able to treat PN effectively by simply blocking the itch and not having a significant inflammatory function is really interesting,” he said in an interview at the meeting. If approved, nemolizumab “gives us another treatment option for a disease that is really debilitating. It’s very promising and we hope [the drug] will be available to us in the near future.”

Nemolizumab is being developed by Galderma. According to a press release from the company, nemolizumab was granted Breakthrough Therapy designation by the Food and Drug Administration in December 2019 for the treatment of pruritus associated with PN, a status that was reconfirmed in February 2023.

Dr. Kwatra disclosed that he is an advisory board member/consultant for Galderma, AbbVie, Amgen, Arcutis, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex, Incyte, Johnson and Johnson, Leo Pharma, Novartis, Pfizer, Regeneron, and Sanofi. Dr. Gordon disclosed that he is a consultant to, an investigator for, and/or a member of the advisory board for several pharmaceutical companies, but not Galderma.

Nemolizumab monotherapy for 16 weeks improved itch, skin lesions, and sleep disturbances in adults with prurigo nodularis (PN), results from a phase 3 trial demonstrated.

Nemolizumab is a first-in-class investigational monoclonal antibody directed against the interleukin-31 receptor alpha that blocks signaling from IL-31. “From prior studies we know that it modulates pruritus, but also alters keratinocyte differentiation, inflammation, and fibrosis,” one of the investigators, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said during a late-breaking research session at the annual meeting of the American Academy of Dermatology.

Dr. Sean Kwatra

OLYMPIA 2 was a phase 3, multicenter, double-blind study in adults with PN presenting with 20 or more nodules, and Investigator’s Global Assessment (IGA) score of 3 or more, and the Peak Pruritus Numerical Rating Scale (PP-NRS) score of 7 or more. Exclusion criteria included chronic pruritus resulting from an active condition other than PN, such as neuropathic and psychogenic pruritus and active atopic dermatitis. In addition, the use of topical steroids, considered a rescue therapy, was not allowed in the trial, Dr. Kwatra said.

After an initial screening period, 274 patients at 73 sites in nine countries were randomized 2:1 either to the nemolizumab monotherapy or placebo. Following an initial 60-mg subcutaneous dose, patients received 30 mg or 60 mg (depending on their baseline weight) every 4 weeks for 16 weeks. The primary endpoint was the proportion of patients with a 4-point or greater improvement in the PP-NRS from baseline at week 16 and the proportion of patients with IGA success at week 16.

Selected key secondary endpoints included the proportion of patients with a 4 point or greater improvement from baseline in the PP-NRS at week 4, the Sleep Disturbance Numerical Rating Scale at week 4, and the SD-NRS at week 16. Safety endpoints included the incidence and severity of all adverse events.

Of the 274 patients randomized, 183 received nemolizumab and 91 received placebo. A total of 174 patients in the nemolizumab group completed the study, compared with 88 in the placebo group. The mean age of study participants was 53 years, 61% were women, 79% were White, 14% were Asian, and the rest were from other racial groups. More than half (57%) had IGA category 3 disease (moderate) and the remainder had IGA category 4 disease (severe); 63% had 20-100 lesions, and the remainder had more than 100. About one-third of study enrollees (32%) had a history of atopy.
 

Primary, secondary endpoint results

Dr. Kwatra reported that 56.3% of the patients in the nemolizumab group achieved a 4-point or greater improvement in the PP-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001), while 37.7% of those in the nemolizumab group achieved IGA success at week 16, compared with 11% of those in the placebo group (P < .0001).

As for secondary endpoints, 41% of patients in the nemolizumab group achieved a 4-point or greater improvement in PP-NRS at week 4, compared with 7.7% of those in the placebo group (P < .0001); and 37.2% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 4, compared with 9.9% of those in the placebo group (P < .0001). Almost 52% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001); and 9.8% of those in the nemolizumab group achieved IGA success at week 4, compared with 1.1% of those in the placebo group (P < .0074).
 

 

 

Adverse events

Treatment-emergent adverse events occurred in 61.2% of subjects in the nemolizumab group, compared with 52.7% of those in the placebo group. “There were no imbalances overall, [including] no injection-related reactions in either group,” Dr. Kwatra said. There was one case of newly diagnosed asthma in the placebo arm, and none in the treatment arm.

The researchers observed a slightly increased onset of atopic dermatitis in the treatment arm, compared with the placebo arm (5.5% vs. 0%). “Seven out of those 10 patients actually had a history of atopic dermatitis or high IgE [levels] and they were mostly managed with topical steroids without study drug discontinuation,” Dr. Kwatra added. Neurodermatitis, or worsening of PN, occurred in 3.8% of patients in the nemolizumab group, compared with 11% of those in the placebo group.

“The results of this study extend the efficacy and safety findings from the phase 2 study of nemolizumab in patients with PN,” Dr. Kwatra concluded. “I think they also help to usher in a new era of PN [treatment] in prime time.”



Kenneth B. Gordon, MD, who chairs the department of dermatology at the Medical College of Wisconsin, Milwaukee, and was asked to comment on the study, was impressed with nemolizumab’s propensity for blocking IL-31. “To be able to treat PN effectively by simply blocking the itch and not having a significant inflammatory function is really interesting,” he said in an interview at the meeting. If approved, nemolizumab “gives us another treatment option for a disease that is really debilitating. It’s very promising and we hope [the drug] will be available to us in the near future.”

Nemolizumab is being developed by Galderma. According to a press release from the company, nemolizumab was granted Breakthrough Therapy designation by the Food and Drug Administration in December 2019 for the treatment of pruritus associated with PN, a status that was reconfirmed in February 2023.

Dr. Kwatra disclosed that he is an advisory board member/consultant for Galderma, AbbVie, Amgen, Arcutis, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex, Incyte, Johnson and Johnson, Leo Pharma, Novartis, Pfizer, Regeneron, and Sanofi. Dr. Gordon disclosed that he is a consultant to, an investigator for, and/or a member of the advisory board for several pharmaceutical companies, but not Galderma.

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Novel single-use patch shows promise for primary axillary hyperhidrosis

Article Type
Changed
Wed, 04/05/2023 - 11:33

Application of a single-use disposable patch to the axillary area for up to 3 minutes led to statistically significant and clinically meaningful benefit for patients with primary axillary hyperhidrosis, results from a pivotal randomized trial showed.

“This is a new kind of device that is going to be a nice tool to have for treating patients who have hyperhidrosis of the axilla,” the study’s lead investigator, David M. Pariser, MD, who practices dermatology in Norfolk, Va., said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology.

Dr. David M. Pariser


In a study known as SAHARA, investigators at 11 sites evaluated the efficacy of the targeted alkali thermolysis (TAT) patch, a single-use disposable device. The patch consists of a thin sodium layer on an adhesive overlay. It’s applied to the dry axilla, and as the patient sweats during treatment, the sweat reacts with the sodium. According to Dr. Pariser, this interaction generates precisely targeted thermal energy that targets sweat glands, leading to a reduction in excessive sweat production for up to three months.

The researchers enrolled 110 individuals with Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4 and randomized them to either an active TAT or a sham patch for up to 3 minutes. Their mean age was about 33 years, and slightly more than half were women. “If significant discomfort or pain was noted, [the patch] treatment was halted; otherwise, it was left on for 3 minutes,” said Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk. “The treated area was thoroughly cleaned after treatment, and the TAT patch was deactivated. This process was repeated on the other axilla.”

The HDSS, Gravimetric Sweat Production (GSP), and quality of life assessments for bother and impact were measured through 12 weeks. The quality of life assessments were an exploratory endpoint and scored from 0 to 4, with 4 being extremely bothered or impacted and 0 not being bothered or impacted at all. The primary efficacy endpoint was the proportion of treated patients achieving a 1 or 2 on the HDSS at week 4, compared with sham treatment.

Secondary endpoints included the proportion of patients with an improvement of at least 2 grades from baseline to 4 weeks in HDSS by treatment group; mean improvement in the quality of life scale bother by treatment group; mean improvement in the quality of life scale impact by treatment group; and the proportion of subjects with at least 50% improvement in GSP from baseline to 4 weeks in the active patch group only.
Koldunov/Thinkstock


Adverse events (AEs) were divided into 3 categories: AEs at the treatment site (or skin reactions within the treated part of the axilla); procedure-related AEs (those that are the result of treatment, but not in the treated part of the axilla), and non-axillary AEs.

Dr. Pariser reported that at 4 weeks, 63.6% of patients in the active patch group versus 44.2% of those in the sham group improved to an HDSS score of 1 or 2 (P = .0332) and that 43.2% of those in the active patch group versus 16.3% of those in the sham group (P = .0107) achieved a 2-point or greater HDSS improvement. In addition, 9.1% of those in the active patch group achieved a 3-point improvement on the HDSS, compared with none in the sham group. “That’s an amazing improvement; you’re basically going from moderate or severe to none,” he commented.

In other findings, 60.5% of patients in the active patch group showed at least a 50% reduction in GSP, compared with 32.6% of those in the sham group (P = .0102), with mean reductions of 57.3 mg/5min and 18.2 mg/5min, respectively (P = .0036). As for quality-of-life outcome scores, bother associated with hyperhidrosis was reduced by 1.52 points in active versus 0.61 in sham subjects (P = .0005), while impact was reduced by 1.44 in active versus 0.57 in sham subjects (P = .0004).

 

 

Adverse events

A total of 13 patients in the active patch group experienced AEs at the treatment site, including six with erythema; four with erosion; two with burning, itching or stinging; and one with underarm odor. “The two procedure-related AEs in the TAT-treated group were compensatory sweating and irritant contact dermatitis due to the adhesive,” said Dr. Pariser said.

Most adverse events resolved in fewer than 2 weeks, and all were mild to moderate. No serious adverse events occurred. Only five adverse events occurred in the sham group.

The TAT patch is currently undergoing review by the Food and Drug Administration, and according to Dr. Pariser, no other body sites have been treated with the device.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, characterized hyperhidrosis as “an exceedingly common medical condition that is commonly overlooked even though it has a tremendous burden on quality of life. I should know, as both someone who manages a large cohort of these patients but also as someone who suffers from it.”

Treatment options “have historically been limited, many of which are off-label and some which are difficult to access due to cost and/or duration/frequency of treatment,” added Dr. Friedman, who was not involved with the study. “The TAT patch offers a new, targeted, in-office, practical procedure-based approach to treat primary axillary hyperhidrosis. Innovation is certainly welcomed and needed, and I am curious to see how this technology is employed in practice once approved.”

The device is being developed by Candesant Biomedical. Dr. Pariser disclosed that he is a consultant or investigator for Bickel Biotechnology, Biofrontera AG, Bristol Myers Squibb, Celgene Corporation, Novartis Pharmaceuticals, Pfizer, Regeneron, and Sanofi.

Dr. Friedman reported having no relevant disclosures.

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Application of a single-use disposable patch to the axillary area for up to 3 minutes led to statistically significant and clinically meaningful benefit for patients with primary axillary hyperhidrosis, results from a pivotal randomized trial showed.

“This is a new kind of device that is going to be a nice tool to have for treating patients who have hyperhidrosis of the axilla,” the study’s lead investigator, David M. Pariser, MD, who practices dermatology in Norfolk, Va., said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology.

Dr. David M. Pariser


In a study known as SAHARA, investigators at 11 sites evaluated the efficacy of the targeted alkali thermolysis (TAT) patch, a single-use disposable device. The patch consists of a thin sodium layer on an adhesive overlay. It’s applied to the dry axilla, and as the patient sweats during treatment, the sweat reacts with the sodium. According to Dr. Pariser, this interaction generates precisely targeted thermal energy that targets sweat glands, leading to a reduction in excessive sweat production for up to three months.

The researchers enrolled 110 individuals with Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4 and randomized them to either an active TAT or a sham patch for up to 3 minutes. Their mean age was about 33 years, and slightly more than half were women. “If significant discomfort or pain was noted, [the patch] treatment was halted; otherwise, it was left on for 3 minutes,” said Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk. “The treated area was thoroughly cleaned after treatment, and the TAT patch was deactivated. This process was repeated on the other axilla.”

The HDSS, Gravimetric Sweat Production (GSP), and quality of life assessments for bother and impact were measured through 12 weeks. The quality of life assessments were an exploratory endpoint and scored from 0 to 4, with 4 being extremely bothered or impacted and 0 not being bothered or impacted at all. The primary efficacy endpoint was the proportion of treated patients achieving a 1 or 2 on the HDSS at week 4, compared with sham treatment.

Secondary endpoints included the proportion of patients with an improvement of at least 2 grades from baseline to 4 weeks in HDSS by treatment group; mean improvement in the quality of life scale bother by treatment group; mean improvement in the quality of life scale impact by treatment group; and the proportion of subjects with at least 50% improvement in GSP from baseline to 4 weeks in the active patch group only.
Koldunov/Thinkstock


Adverse events (AEs) were divided into 3 categories: AEs at the treatment site (or skin reactions within the treated part of the axilla); procedure-related AEs (those that are the result of treatment, but not in the treated part of the axilla), and non-axillary AEs.

Dr. Pariser reported that at 4 weeks, 63.6% of patients in the active patch group versus 44.2% of those in the sham group improved to an HDSS score of 1 or 2 (P = .0332) and that 43.2% of those in the active patch group versus 16.3% of those in the sham group (P = .0107) achieved a 2-point or greater HDSS improvement. In addition, 9.1% of those in the active patch group achieved a 3-point improvement on the HDSS, compared with none in the sham group. “That’s an amazing improvement; you’re basically going from moderate or severe to none,” he commented.

In other findings, 60.5% of patients in the active patch group showed at least a 50% reduction in GSP, compared with 32.6% of those in the sham group (P = .0102), with mean reductions of 57.3 mg/5min and 18.2 mg/5min, respectively (P = .0036). As for quality-of-life outcome scores, bother associated with hyperhidrosis was reduced by 1.52 points in active versus 0.61 in sham subjects (P = .0005), while impact was reduced by 1.44 in active versus 0.57 in sham subjects (P = .0004).

 

 

Adverse events

A total of 13 patients in the active patch group experienced AEs at the treatment site, including six with erythema; four with erosion; two with burning, itching or stinging; and one with underarm odor. “The two procedure-related AEs in the TAT-treated group were compensatory sweating and irritant contact dermatitis due to the adhesive,” said Dr. Pariser said.

Most adverse events resolved in fewer than 2 weeks, and all were mild to moderate. No serious adverse events occurred. Only five adverse events occurred in the sham group.

The TAT patch is currently undergoing review by the Food and Drug Administration, and according to Dr. Pariser, no other body sites have been treated with the device.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, characterized hyperhidrosis as “an exceedingly common medical condition that is commonly overlooked even though it has a tremendous burden on quality of life. I should know, as both someone who manages a large cohort of these patients but also as someone who suffers from it.”

Treatment options “have historically been limited, many of which are off-label and some which are difficult to access due to cost and/or duration/frequency of treatment,” added Dr. Friedman, who was not involved with the study. “The TAT patch offers a new, targeted, in-office, practical procedure-based approach to treat primary axillary hyperhidrosis. Innovation is certainly welcomed and needed, and I am curious to see how this technology is employed in practice once approved.”

The device is being developed by Candesant Biomedical. Dr. Pariser disclosed that he is a consultant or investigator for Bickel Biotechnology, Biofrontera AG, Bristol Myers Squibb, Celgene Corporation, Novartis Pharmaceuticals, Pfizer, Regeneron, and Sanofi.

Dr. Friedman reported having no relevant disclosures.

Application of a single-use disposable patch to the axillary area for up to 3 minutes led to statistically significant and clinically meaningful benefit for patients with primary axillary hyperhidrosis, results from a pivotal randomized trial showed.

“This is a new kind of device that is going to be a nice tool to have for treating patients who have hyperhidrosis of the axilla,” the study’s lead investigator, David M. Pariser, MD, who practices dermatology in Norfolk, Va., said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology.

Dr. David M. Pariser


In a study known as SAHARA, investigators at 11 sites evaluated the efficacy of the targeted alkali thermolysis (TAT) patch, a single-use disposable device. The patch consists of a thin sodium layer on an adhesive overlay. It’s applied to the dry axilla, and as the patient sweats during treatment, the sweat reacts with the sodium. According to Dr. Pariser, this interaction generates precisely targeted thermal energy that targets sweat glands, leading to a reduction in excessive sweat production for up to three months.

The researchers enrolled 110 individuals with Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4 and randomized them to either an active TAT or a sham patch for up to 3 minutes. Their mean age was about 33 years, and slightly more than half were women. “If significant discomfort or pain was noted, [the patch] treatment was halted; otherwise, it was left on for 3 minutes,” said Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk. “The treated area was thoroughly cleaned after treatment, and the TAT patch was deactivated. This process was repeated on the other axilla.”

The HDSS, Gravimetric Sweat Production (GSP), and quality of life assessments for bother and impact were measured through 12 weeks. The quality of life assessments were an exploratory endpoint and scored from 0 to 4, with 4 being extremely bothered or impacted and 0 not being bothered or impacted at all. The primary efficacy endpoint was the proportion of treated patients achieving a 1 or 2 on the HDSS at week 4, compared with sham treatment.

Secondary endpoints included the proportion of patients with an improvement of at least 2 grades from baseline to 4 weeks in HDSS by treatment group; mean improvement in the quality of life scale bother by treatment group; mean improvement in the quality of life scale impact by treatment group; and the proportion of subjects with at least 50% improvement in GSP from baseline to 4 weeks in the active patch group only.
Koldunov/Thinkstock


Adverse events (AEs) were divided into 3 categories: AEs at the treatment site (or skin reactions within the treated part of the axilla); procedure-related AEs (those that are the result of treatment, but not in the treated part of the axilla), and non-axillary AEs.

Dr. Pariser reported that at 4 weeks, 63.6% of patients in the active patch group versus 44.2% of those in the sham group improved to an HDSS score of 1 or 2 (P = .0332) and that 43.2% of those in the active patch group versus 16.3% of those in the sham group (P = .0107) achieved a 2-point or greater HDSS improvement. In addition, 9.1% of those in the active patch group achieved a 3-point improvement on the HDSS, compared with none in the sham group. “That’s an amazing improvement; you’re basically going from moderate or severe to none,” he commented.

In other findings, 60.5% of patients in the active patch group showed at least a 50% reduction in GSP, compared with 32.6% of those in the sham group (P = .0102), with mean reductions of 57.3 mg/5min and 18.2 mg/5min, respectively (P = .0036). As for quality-of-life outcome scores, bother associated with hyperhidrosis was reduced by 1.52 points in active versus 0.61 in sham subjects (P = .0005), while impact was reduced by 1.44 in active versus 0.57 in sham subjects (P = .0004).

 

 

Adverse events

A total of 13 patients in the active patch group experienced AEs at the treatment site, including six with erythema; four with erosion; two with burning, itching or stinging; and one with underarm odor. “The two procedure-related AEs in the TAT-treated group were compensatory sweating and irritant contact dermatitis due to the adhesive,” said Dr. Pariser said.

Most adverse events resolved in fewer than 2 weeks, and all were mild to moderate. No serious adverse events occurred. Only five adverse events occurred in the sham group.

The TAT patch is currently undergoing review by the Food and Drug Administration, and according to Dr. Pariser, no other body sites have been treated with the device.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, characterized hyperhidrosis as “an exceedingly common medical condition that is commonly overlooked even though it has a tremendous burden on quality of life. I should know, as both someone who manages a large cohort of these patients but also as someone who suffers from it.”

Treatment options “have historically been limited, many of which are off-label and some which are difficult to access due to cost and/or duration/frequency of treatment,” added Dr. Friedman, who was not involved with the study. “The TAT patch offers a new, targeted, in-office, practical procedure-based approach to treat primary axillary hyperhidrosis. Innovation is certainly welcomed and needed, and I am curious to see how this technology is employed in practice once approved.”

The device is being developed by Candesant Biomedical. Dr. Pariser disclosed that he is a consultant or investigator for Bickel Biotechnology, Biofrontera AG, Bristol Myers Squibb, Celgene Corporation, Novartis Pharmaceuticals, Pfizer, Regeneron, and Sanofi.

Dr. Friedman reported having no relevant disclosures.

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CSU in children: Study identifies biomarkers associated with responses to different treatments

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Mon, 03/20/2023 - 10:29

Assessing underlying mechanisms for the effects of age, mean platelet volume (MPV), and tryptase may help identify pediatric patients with chronic spontaneous urticaria (CSU) who will respond to different treatment options, results from a single-center prospective study showed.

“Given that the majority of CSU cases in adults are due to autoimmunity and there being very [few] studies on biomarkers for CSU in children, our study furthers our current understanding of the role of different biomarkers in treatment response,” lead study author Alex Nguyen, MsC, said in an interview at the annual meeting of the American Academy of Dermatology, where the study was presented during a poster session.

Alex Nguyen


To identify biomarkers with treatment and disease resolution in children with CSU, Mr. Nguyen, a 4-year medical student at McGill University, Montreal, and colleagues prospectively recruited 109 children from the Montreal Children’s Hospital Allergy and Immunology Clinic who reported hives for at least 6 weeks from 2013 to 2022. They obtained levels of thyroid stimulating hormone (TSH), anti-thyroxine peroxidase (anti-TPO), total immunoglobulin E (IgE), CD63, tryptase, eosinophils, MPV, and platelets; the weekly urticaria activity score (UAS7) was recorded at study entry.

Levels of treatment included antihistamines at standard dose, four times the standard dose, omalizumab, and resolution of treatment. The researchers used univariate and multivariate logistic regressions to determine factors associated with different treatment levels and resolution.

Slightly more than half of the study participants (55%) were female, and their mean age was 9 years. Mr. Nguyen and colleagues observed that elevated MPV was associated with the four times increased dose of antihistamines treatment level (odds ratio = 1.052, 95% confidence interval = 1.004-1.103). Lower age was associated with disease resolution (OR = 0.982, 95% CI = 0.965-0.999).

After adjustment for age, sex, TSH, anti-TPO, total IgE, CD63, eosinophils, MPV, and platelets, elevated tryptase was associated with the antihistamine use at standard dose level (OR = 1.152, 95% CI = 1.019-1.302) and lower tryptase levels with disease resolution (OR = .861, 95% CI = 0.777-0.955).

“We were fascinated when we found that tryptase levels in patients with chronic spontaneous urticaria were associated with standard dose of antihistamines and even disease resolution,” Mr. Nguyen said. “Higher tryptase levels were associated with standard dose antihistamines, which potentially could imply an increase in mast cell activation. Furthermore, we saw that lower tryptase levels were associated with disease resolution likely given if the disease may not have been as severe.”

He acknowledged certain limitations of the study, including a limited sample size and an unbalanced sample size among treatment groups. In the future, he and his colleagues plan to increase the sample size and to include other biomarkers such as interleukin (IL)-6, D-dimer, vitamin D, and matrix mettaloproteinase-9.

“Much as the name suggests, CSU often arises without a clear trigger,” said Raj Chovatiya, MD, PhD, assistant professor in the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study. “Particularly in children, little is known about potential biomarkers that may guide treatment or disease resolution. While a larger, prospective analysis would better characterize temporal trends in serum biomarkers in relation to disease activity, these data suggest that underlying mechanisms of tryptase may be worth an in-depth look in children with CSU.”

The study was recognized as the second-best poster at the meeting. The researchers reported having no financial disclosures. The other study coauthors were Michelle Le MD, Sofianne Gabrielli MSc, Elena Netchiporouk, MD, MSc, and Moshe Ben-Shoshan, MD, MSc. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for several pharmaceutical companies.

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Assessing underlying mechanisms for the effects of age, mean platelet volume (MPV), and tryptase may help identify pediatric patients with chronic spontaneous urticaria (CSU) who will respond to different treatment options, results from a single-center prospective study showed.

“Given that the majority of CSU cases in adults are due to autoimmunity and there being very [few] studies on biomarkers for CSU in children, our study furthers our current understanding of the role of different biomarkers in treatment response,” lead study author Alex Nguyen, MsC, said in an interview at the annual meeting of the American Academy of Dermatology, where the study was presented during a poster session.

Alex Nguyen


To identify biomarkers with treatment and disease resolution in children with CSU, Mr. Nguyen, a 4-year medical student at McGill University, Montreal, and colleagues prospectively recruited 109 children from the Montreal Children’s Hospital Allergy and Immunology Clinic who reported hives for at least 6 weeks from 2013 to 2022. They obtained levels of thyroid stimulating hormone (TSH), anti-thyroxine peroxidase (anti-TPO), total immunoglobulin E (IgE), CD63, tryptase, eosinophils, MPV, and platelets; the weekly urticaria activity score (UAS7) was recorded at study entry.

Levels of treatment included antihistamines at standard dose, four times the standard dose, omalizumab, and resolution of treatment. The researchers used univariate and multivariate logistic regressions to determine factors associated with different treatment levels and resolution.

Slightly more than half of the study participants (55%) were female, and their mean age was 9 years. Mr. Nguyen and colleagues observed that elevated MPV was associated with the four times increased dose of antihistamines treatment level (odds ratio = 1.052, 95% confidence interval = 1.004-1.103). Lower age was associated with disease resolution (OR = 0.982, 95% CI = 0.965-0.999).

After adjustment for age, sex, TSH, anti-TPO, total IgE, CD63, eosinophils, MPV, and platelets, elevated tryptase was associated with the antihistamine use at standard dose level (OR = 1.152, 95% CI = 1.019-1.302) and lower tryptase levels with disease resolution (OR = .861, 95% CI = 0.777-0.955).

“We were fascinated when we found that tryptase levels in patients with chronic spontaneous urticaria were associated with standard dose of antihistamines and even disease resolution,” Mr. Nguyen said. “Higher tryptase levels were associated with standard dose antihistamines, which potentially could imply an increase in mast cell activation. Furthermore, we saw that lower tryptase levels were associated with disease resolution likely given if the disease may not have been as severe.”

He acknowledged certain limitations of the study, including a limited sample size and an unbalanced sample size among treatment groups. In the future, he and his colleagues plan to increase the sample size and to include other biomarkers such as interleukin (IL)-6, D-dimer, vitamin D, and matrix mettaloproteinase-9.

“Much as the name suggests, CSU often arises without a clear trigger,” said Raj Chovatiya, MD, PhD, assistant professor in the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study. “Particularly in children, little is known about potential biomarkers that may guide treatment or disease resolution. While a larger, prospective analysis would better characterize temporal trends in serum biomarkers in relation to disease activity, these data suggest that underlying mechanisms of tryptase may be worth an in-depth look in children with CSU.”

The study was recognized as the second-best poster at the meeting. The researchers reported having no financial disclosures. The other study coauthors were Michelle Le MD, Sofianne Gabrielli MSc, Elena Netchiporouk, MD, MSc, and Moshe Ben-Shoshan, MD, MSc. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for several pharmaceutical companies.

Assessing underlying mechanisms for the effects of age, mean platelet volume (MPV), and tryptase may help identify pediatric patients with chronic spontaneous urticaria (CSU) who will respond to different treatment options, results from a single-center prospective study showed.

“Given that the majority of CSU cases in adults are due to autoimmunity and there being very [few] studies on biomarkers for CSU in children, our study furthers our current understanding of the role of different biomarkers in treatment response,” lead study author Alex Nguyen, MsC, said in an interview at the annual meeting of the American Academy of Dermatology, where the study was presented during a poster session.

Alex Nguyen


To identify biomarkers with treatment and disease resolution in children with CSU, Mr. Nguyen, a 4-year medical student at McGill University, Montreal, and colleagues prospectively recruited 109 children from the Montreal Children’s Hospital Allergy and Immunology Clinic who reported hives for at least 6 weeks from 2013 to 2022. They obtained levels of thyroid stimulating hormone (TSH), anti-thyroxine peroxidase (anti-TPO), total immunoglobulin E (IgE), CD63, tryptase, eosinophils, MPV, and platelets; the weekly urticaria activity score (UAS7) was recorded at study entry.

Levels of treatment included antihistamines at standard dose, four times the standard dose, omalizumab, and resolution of treatment. The researchers used univariate and multivariate logistic regressions to determine factors associated with different treatment levels and resolution.

Slightly more than half of the study participants (55%) were female, and their mean age was 9 years. Mr. Nguyen and colleagues observed that elevated MPV was associated with the four times increased dose of antihistamines treatment level (odds ratio = 1.052, 95% confidence interval = 1.004-1.103). Lower age was associated with disease resolution (OR = 0.982, 95% CI = 0.965-0.999).

After adjustment for age, sex, TSH, anti-TPO, total IgE, CD63, eosinophils, MPV, and platelets, elevated tryptase was associated with the antihistamine use at standard dose level (OR = 1.152, 95% CI = 1.019-1.302) and lower tryptase levels with disease resolution (OR = .861, 95% CI = 0.777-0.955).

“We were fascinated when we found that tryptase levels in patients with chronic spontaneous urticaria were associated with standard dose of antihistamines and even disease resolution,” Mr. Nguyen said. “Higher tryptase levels were associated with standard dose antihistamines, which potentially could imply an increase in mast cell activation. Furthermore, we saw that lower tryptase levels were associated with disease resolution likely given if the disease may not have been as severe.”

He acknowledged certain limitations of the study, including a limited sample size and an unbalanced sample size among treatment groups. In the future, he and his colleagues plan to increase the sample size and to include other biomarkers such as interleukin (IL)-6, D-dimer, vitamin D, and matrix mettaloproteinase-9.

“Much as the name suggests, CSU often arises without a clear trigger,” said Raj Chovatiya, MD, PhD, assistant professor in the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study. “Particularly in children, little is known about potential biomarkers that may guide treatment or disease resolution. While a larger, prospective analysis would better characterize temporal trends in serum biomarkers in relation to disease activity, these data suggest that underlying mechanisms of tryptase may be worth an in-depth look in children with CSU.”

The study was recognized as the second-best poster at the meeting. The researchers reported having no financial disclosures. The other study coauthors were Michelle Le MD, Sofianne Gabrielli MSc, Elena Netchiporouk, MD, MSc, and Moshe Ben-Shoshan, MD, MSc. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for several pharmaceutical companies.

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Study finds quality of topical steroid withdrawal videos on YouTube subpar

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Wed, 04/05/2023 - 11:34

Among the 10 most viewed YouTube videos regarding topical steroid withdrawal, patient testimonials had the poorest quality and reliability of all information sources, results from a novel analysis showed.

Dr. Adam Friedman

“Video-sharing platforms such as YouTube are a great place for patients to connect and find community with others dealing with the same conditions,” senior author Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said in an interview in advance of the annual meeting of the American Academy of Dermatology, where the study was presented during an e-poster session. “There is no doubt tremendous value in viewing the shared experience; however, it is important that medical advice be evidence based and validated. Seeking said advice from a medical professional such as a board-certified dermatologist will no doubt increase the likelihood that said guidance is supported by the literature and most importantly, will do no harm.”

Noting a trend of increased user-created content on social media and Internet sites about topical steroid withdrawal in recent years, Dr. Friedman, first author Erika McCormick, a fourth-year medical student at George Washington University, and colleagues used the keywords “topical steroid withdrawal” on YouTube to search for and analyze the top 10 most viewed videos on the subject.



Two independent reviewers used the modified DISCERN (mDISCERN) tool and the Global Quality Scale (GQS) to assess reliability and quality/scientific accuracy of videos, respectively. Average scores were generated for each video and the researchers used one way ANOVA, unpaired t-tests, and linear regression to analyze the ratings. For mDISCERN criteria, a point is given per each of five criteria for a possible score between 0 and 5. Examples of criteria included “Are the aims clear and achieved?” and “Is the information presented both balanced and unbiased”? For GQS, a score from 1 to 5 is designated based on criteria ranging from “poor quality, poor flow, most information missing” to “excellent quality and flow, very useful for patients.”

The researchers found that the mean combined mDISCERN score of the 10 videos was a 2, which indicates poor reliability and shortcomings. Similarly, the combined mean GQS score was 2.5, which suggests poor to moderate quality of videos, missing discussion of important topics, and limited use to patients. The researchers found no correlation between mDISCERN or GQS scores and length of video, duration on YouTube, or number of views, subscribers, or likes.

Erika McCormick

“We were disheartened that patient testimonial videos had the poorest quality and reliability of the information sources,” Ms. McCormick said in an interview. “Videos that included medical research and information from dermatologists had significantly higher quality and reliability scores than the remainder of videos.” Accurate information online is essential to help patients recognize topical steroid withdrawal and seek medical care, she continued.

Conversely, wide viewership of unreliable information “may contribute to fear of topical corticosteroids and dissuade use in patients with primary skin diseases that may benefit from this common treatment,” Dr. Friedman said. “Dermatologists must be aware of the content patients are consuming online, should guide patients in appraising quality and reliability of online resources, and must provide valid sources of additional information for their patients.” One such resource he recommended is the National Eczema Association, which has created online content for patients about topical steroid withdrawal.

Dr. Doris Day

Doris Day, MD, a New York–based dermatologist who was asked to comment on the study, said that many patients rely on YouTube as a go-to resource, with videos that can be watched at times of their choosing. “Oftentimes, the person on the video is relatable and has some general knowledge but is lacking the information that would be relevant and important for the individual patient,” said Dr. Day, who was not involved with the study. “The downside of this is that the person who takes that advice may not use the prescription properly or for the correct amount of time, which can lead to either undertreating or, even worse, overtreatment, which can have permanent consequences.”

One possible solution is for more doctors to create videos for YouTube, she added, “but that doesn’t guarantee that those would be the ones patients would choose to watch.” Another solution “is to have YouTube add qualifiers indicating that the information being discussed is not medical,” she suggested. “Ideally, patients will get all the information they need while they are in the office and also have clear written instructions and even a video they can review at a later time, made by the office, to help them feel they are getting personalized care and the attention they need.”

Ms. McCormick’s research is funded by a grant from Galderma. Dr. Friedman and Dr. Day had no relevant disclosures to report.

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Among the 10 most viewed YouTube videos regarding topical steroid withdrawal, patient testimonials had the poorest quality and reliability of all information sources, results from a novel analysis showed.

Dr. Adam Friedman

“Video-sharing platforms such as YouTube are a great place for patients to connect and find community with others dealing with the same conditions,” senior author Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said in an interview in advance of the annual meeting of the American Academy of Dermatology, where the study was presented during an e-poster session. “There is no doubt tremendous value in viewing the shared experience; however, it is important that medical advice be evidence based and validated. Seeking said advice from a medical professional such as a board-certified dermatologist will no doubt increase the likelihood that said guidance is supported by the literature and most importantly, will do no harm.”

Noting a trend of increased user-created content on social media and Internet sites about topical steroid withdrawal in recent years, Dr. Friedman, first author Erika McCormick, a fourth-year medical student at George Washington University, and colleagues used the keywords “topical steroid withdrawal” on YouTube to search for and analyze the top 10 most viewed videos on the subject.



Two independent reviewers used the modified DISCERN (mDISCERN) tool and the Global Quality Scale (GQS) to assess reliability and quality/scientific accuracy of videos, respectively. Average scores were generated for each video and the researchers used one way ANOVA, unpaired t-tests, and linear regression to analyze the ratings. For mDISCERN criteria, a point is given per each of five criteria for a possible score between 0 and 5. Examples of criteria included “Are the aims clear and achieved?” and “Is the information presented both balanced and unbiased”? For GQS, a score from 1 to 5 is designated based on criteria ranging from “poor quality, poor flow, most information missing” to “excellent quality and flow, very useful for patients.”

The researchers found that the mean combined mDISCERN score of the 10 videos was a 2, which indicates poor reliability and shortcomings. Similarly, the combined mean GQS score was 2.5, which suggests poor to moderate quality of videos, missing discussion of important topics, and limited use to patients. The researchers found no correlation between mDISCERN or GQS scores and length of video, duration on YouTube, or number of views, subscribers, or likes.

Erika McCormick

“We were disheartened that patient testimonial videos had the poorest quality and reliability of the information sources,” Ms. McCormick said in an interview. “Videos that included medical research and information from dermatologists had significantly higher quality and reliability scores than the remainder of videos.” Accurate information online is essential to help patients recognize topical steroid withdrawal and seek medical care, she continued.

Conversely, wide viewership of unreliable information “may contribute to fear of topical corticosteroids and dissuade use in patients with primary skin diseases that may benefit from this common treatment,” Dr. Friedman said. “Dermatologists must be aware of the content patients are consuming online, should guide patients in appraising quality and reliability of online resources, and must provide valid sources of additional information for their patients.” One such resource he recommended is the National Eczema Association, which has created online content for patients about topical steroid withdrawal.

Dr. Doris Day

Doris Day, MD, a New York–based dermatologist who was asked to comment on the study, said that many patients rely on YouTube as a go-to resource, with videos that can be watched at times of their choosing. “Oftentimes, the person on the video is relatable and has some general knowledge but is lacking the information that would be relevant and important for the individual patient,” said Dr. Day, who was not involved with the study. “The downside of this is that the person who takes that advice may not use the prescription properly or for the correct amount of time, which can lead to either undertreating or, even worse, overtreatment, which can have permanent consequences.”

One possible solution is for more doctors to create videos for YouTube, she added, “but that doesn’t guarantee that those would be the ones patients would choose to watch.” Another solution “is to have YouTube add qualifiers indicating that the information being discussed is not medical,” she suggested. “Ideally, patients will get all the information they need while they are in the office and also have clear written instructions and even a video they can review at a later time, made by the office, to help them feel they are getting personalized care and the attention they need.”

Ms. McCormick’s research is funded by a grant from Galderma. Dr. Friedman and Dr. Day had no relevant disclosures to report.

Among the 10 most viewed YouTube videos regarding topical steroid withdrawal, patient testimonials had the poorest quality and reliability of all information sources, results from a novel analysis showed.

Dr. Adam Friedman

“Video-sharing platforms such as YouTube are a great place for patients to connect and find community with others dealing with the same conditions,” senior author Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said in an interview in advance of the annual meeting of the American Academy of Dermatology, where the study was presented during an e-poster session. “There is no doubt tremendous value in viewing the shared experience; however, it is important that medical advice be evidence based and validated. Seeking said advice from a medical professional such as a board-certified dermatologist will no doubt increase the likelihood that said guidance is supported by the literature and most importantly, will do no harm.”

Noting a trend of increased user-created content on social media and Internet sites about topical steroid withdrawal in recent years, Dr. Friedman, first author Erika McCormick, a fourth-year medical student at George Washington University, and colleagues used the keywords “topical steroid withdrawal” on YouTube to search for and analyze the top 10 most viewed videos on the subject.



Two independent reviewers used the modified DISCERN (mDISCERN) tool and the Global Quality Scale (GQS) to assess reliability and quality/scientific accuracy of videos, respectively. Average scores were generated for each video and the researchers used one way ANOVA, unpaired t-tests, and linear regression to analyze the ratings. For mDISCERN criteria, a point is given per each of five criteria for a possible score between 0 and 5. Examples of criteria included “Are the aims clear and achieved?” and “Is the information presented both balanced and unbiased”? For GQS, a score from 1 to 5 is designated based on criteria ranging from “poor quality, poor flow, most information missing” to “excellent quality and flow, very useful for patients.”

The researchers found that the mean combined mDISCERN score of the 10 videos was a 2, which indicates poor reliability and shortcomings. Similarly, the combined mean GQS score was 2.5, which suggests poor to moderate quality of videos, missing discussion of important topics, and limited use to patients. The researchers found no correlation between mDISCERN or GQS scores and length of video, duration on YouTube, or number of views, subscribers, or likes.

Erika McCormick

“We were disheartened that patient testimonial videos had the poorest quality and reliability of the information sources,” Ms. McCormick said in an interview. “Videos that included medical research and information from dermatologists had significantly higher quality and reliability scores than the remainder of videos.” Accurate information online is essential to help patients recognize topical steroid withdrawal and seek medical care, she continued.

Conversely, wide viewership of unreliable information “may contribute to fear of topical corticosteroids and dissuade use in patients with primary skin diseases that may benefit from this common treatment,” Dr. Friedman said. “Dermatologists must be aware of the content patients are consuming online, should guide patients in appraising quality and reliability of online resources, and must provide valid sources of additional information for their patients.” One such resource he recommended is the National Eczema Association, which has created online content for patients about topical steroid withdrawal.

Dr. Doris Day

Doris Day, MD, a New York–based dermatologist who was asked to comment on the study, said that many patients rely on YouTube as a go-to resource, with videos that can be watched at times of their choosing. “Oftentimes, the person on the video is relatable and has some general knowledge but is lacking the information that would be relevant and important for the individual patient,” said Dr. Day, who was not involved with the study. “The downside of this is that the person who takes that advice may not use the prescription properly or for the correct amount of time, which can lead to either undertreating or, even worse, overtreatment, which can have permanent consequences.”

One possible solution is for more doctors to create videos for YouTube, she added, “but that doesn’t guarantee that those would be the ones patients would choose to watch.” Another solution “is to have YouTube add qualifiers indicating that the information being discussed is not medical,” she suggested. “Ideally, patients will get all the information they need while they are in the office and also have clear written instructions and even a video they can review at a later time, made by the office, to help them feel they are getting personalized care and the attention they need.”

Ms. McCormick’s research is funded by a grant from Galderma. Dr. Friedman and Dr. Day had no relevant disclosures to report.

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Spironolactone: an ‘inexpensive, effective’ option for acne in women

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Wed, 04/05/2023 - 11:35

– In the clinical experience of Julie C. Harper, MD, an increasing number of women with acne are turning to off-label, long-term treatment with spironolactone.

“Spironolactone is fairly accessible, inexpensive, and effective for our patients,” Dr. Harper, a dermatologist who practices in Birmingham, Ala., said at the Hawaii Dermatology Seminar provided by MedscapeLIVE!

An aldosterone receptor antagonist commonly used to treat high blood pressure and heart failure, spironolactone also has antiandrogenic properties with a proven track record for treating acne and hirsutism. It reduces androgen production, inhibits 5-alpha reductase, and increases sex hormone binding globulin. The dosing range for treating acne is 25 mg to 200 mg per day, but Dr. Harper prefers a maximum dose of 100 mg per day.

According to a systematic review of its use for acne in adult women, the most common side effect is menstrual irregularity, while other common side effects include breast tenderness/swelling, fatigue, and headaches.

“The higher the dose, the higher the rate of side effects,” she said. Concomitant use of an oral contraceptive lessens menstrual irregularities and prevents pregnancies, to avoid exposure during pregnancy and the hypothetical risk of feminization of the male fetus with exposure late in the first trimester. “Early in my career, I used to say if you’re going to be on spironolactone you’re also going to be on an oral contraceptive. But the longer I’ve practiced, I’ve learned that women who have a contraindication to birth control pills or who don’t want to take it can still benefit from an oral antiandrogen by being on spironolactone.”

A large retrospective analysis of 14-year data concluded that routine potassium monitoring is unnecessary for healthy women taking spironolactone for acne. “If you’re between the ages of 18 and 45, healthy, and not taking other medications where I’m worried about potassium levels, I’m not checking those levels at all,” Dr. Harper said.

Spironolactone labeling includes a boxed warning regarding the potential for tumorigenicity based on rat studies, but the dosages used in those studies were 25-250 times higher than the exposure dose in humans, Dr. Harper said.

Results from a systematic review and meta-analysis of seven studies in the medical literature found no evidence of an increased risk of breast cancer in women with exposure to spironolactone. “However, the certainty of the evidence was low and future studies are needed, including among diverse populations such as younger individuals and those with acne or hirsutism,” the study authors wrote.



In a separate study, researchers drew from patients in the Humana Insurance database from 2005 to 2017 to address whether spironolactone is associated with an increased risk of recurrence of breast cancer. Recurrent breast cancer was examined in 29,146 women with continuous health insurance for 2 years after a diagnosis of breast cancer. Of these, 746 were prescribed spironolactone, and the remainder were not. The researchers found that 123 women (16.5%) who were prescribed spironolactone had a breast cancer recurrence, compared with 3,649 women (12.8%) with a breast cancer recurrence who had not been prescribed spironolactone (P = .004). Adjusted Cox regression analysis following propensity matching showed no association between spironolactone and increased breast cancer recurrence (adjusted hazard ratio, 0.966; P = .953).

According to Dr. Harper, spironolactone may take about 3 months to kick in. “Likely this is a long-term treatment, and most of the time we’re going to be using it in combination with other acne treatments such as topical retinoids or topical benzoyl peroxide, oral antibiotics, or even isotretinoin.”

A study of long-term spironolactone use in 403 women found that the most common dose prescribed was 100 mg/day, and 68% of the women were concurrently prescribed a topical retinoid, 2.2% an oral antibiotic, and 40.7% an oral contraceptive.

The study population included 32 patients with a history of polycystic ovarian syndrome, 1 with a history of breast cancer, and 5 were hypercoagulable. Patients took the drug for a mean of 471 days. “As opposed to our antibiotics, where the course for patients is generally 3-4 months, when you start someone on spironolactone, they may end up staying on it,” Dr. Harper said.

Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, Cassiopeia, Cutera, EPI, Galderma, L’Oreal, Ortho Dermatologics, Sol Gel, and Vyne. She also serves as a speaker or member of a speaker’s bureau for Almirall, Cassiopeia, Cutera, EPI, Galderma, Journey Almirall, L’Oreal, Ortho Dermatologics, Sun Pharmaceutical Industries, and Vyne.

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– In the clinical experience of Julie C. Harper, MD, an increasing number of women with acne are turning to off-label, long-term treatment with spironolactone.

“Spironolactone is fairly accessible, inexpensive, and effective for our patients,” Dr. Harper, a dermatologist who practices in Birmingham, Ala., said at the Hawaii Dermatology Seminar provided by MedscapeLIVE!

An aldosterone receptor antagonist commonly used to treat high blood pressure and heart failure, spironolactone also has antiandrogenic properties with a proven track record for treating acne and hirsutism. It reduces androgen production, inhibits 5-alpha reductase, and increases sex hormone binding globulin. The dosing range for treating acne is 25 mg to 200 mg per day, but Dr. Harper prefers a maximum dose of 100 mg per day.

According to a systematic review of its use for acne in adult women, the most common side effect is menstrual irregularity, while other common side effects include breast tenderness/swelling, fatigue, and headaches.

“The higher the dose, the higher the rate of side effects,” she said. Concomitant use of an oral contraceptive lessens menstrual irregularities and prevents pregnancies, to avoid exposure during pregnancy and the hypothetical risk of feminization of the male fetus with exposure late in the first trimester. “Early in my career, I used to say if you’re going to be on spironolactone you’re also going to be on an oral contraceptive. But the longer I’ve practiced, I’ve learned that women who have a contraindication to birth control pills or who don’t want to take it can still benefit from an oral antiandrogen by being on spironolactone.”

A large retrospective analysis of 14-year data concluded that routine potassium monitoring is unnecessary for healthy women taking spironolactone for acne. “If you’re between the ages of 18 and 45, healthy, and not taking other medications where I’m worried about potassium levels, I’m not checking those levels at all,” Dr. Harper said.

Spironolactone labeling includes a boxed warning regarding the potential for tumorigenicity based on rat studies, but the dosages used in those studies were 25-250 times higher than the exposure dose in humans, Dr. Harper said.

Results from a systematic review and meta-analysis of seven studies in the medical literature found no evidence of an increased risk of breast cancer in women with exposure to spironolactone. “However, the certainty of the evidence was low and future studies are needed, including among diverse populations such as younger individuals and those with acne or hirsutism,” the study authors wrote.



In a separate study, researchers drew from patients in the Humana Insurance database from 2005 to 2017 to address whether spironolactone is associated with an increased risk of recurrence of breast cancer. Recurrent breast cancer was examined in 29,146 women with continuous health insurance for 2 years after a diagnosis of breast cancer. Of these, 746 were prescribed spironolactone, and the remainder were not. The researchers found that 123 women (16.5%) who were prescribed spironolactone had a breast cancer recurrence, compared with 3,649 women (12.8%) with a breast cancer recurrence who had not been prescribed spironolactone (P = .004). Adjusted Cox regression analysis following propensity matching showed no association between spironolactone and increased breast cancer recurrence (adjusted hazard ratio, 0.966; P = .953).

According to Dr. Harper, spironolactone may take about 3 months to kick in. “Likely this is a long-term treatment, and most of the time we’re going to be using it in combination with other acne treatments such as topical retinoids or topical benzoyl peroxide, oral antibiotics, or even isotretinoin.”

A study of long-term spironolactone use in 403 women found that the most common dose prescribed was 100 mg/day, and 68% of the women were concurrently prescribed a topical retinoid, 2.2% an oral antibiotic, and 40.7% an oral contraceptive.

The study population included 32 patients with a history of polycystic ovarian syndrome, 1 with a history of breast cancer, and 5 were hypercoagulable. Patients took the drug for a mean of 471 days. “As opposed to our antibiotics, where the course for patients is generally 3-4 months, when you start someone on spironolactone, they may end up staying on it,” Dr. Harper said.

Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, Cassiopeia, Cutera, EPI, Galderma, L’Oreal, Ortho Dermatologics, Sol Gel, and Vyne. She also serves as a speaker or member of a speaker’s bureau for Almirall, Cassiopeia, Cutera, EPI, Galderma, Journey Almirall, L’Oreal, Ortho Dermatologics, Sun Pharmaceutical Industries, and Vyne.

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

– In the clinical experience of Julie C. Harper, MD, an increasing number of women with acne are turning to off-label, long-term treatment with spironolactone.

“Spironolactone is fairly accessible, inexpensive, and effective for our patients,” Dr. Harper, a dermatologist who practices in Birmingham, Ala., said at the Hawaii Dermatology Seminar provided by MedscapeLIVE!

An aldosterone receptor antagonist commonly used to treat high blood pressure and heart failure, spironolactone also has antiandrogenic properties with a proven track record for treating acne and hirsutism. It reduces androgen production, inhibits 5-alpha reductase, and increases sex hormone binding globulin. The dosing range for treating acne is 25 mg to 200 mg per day, but Dr. Harper prefers a maximum dose of 100 mg per day.

According to a systematic review of its use for acne in adult women, the most common side effect is menstrual irregularity, while other common side effects include breast tenderness/swelling, fatigue, and headaches.

“The higher the dose, the higher the rate of side effects,” she said. Concomitant use of an oral contraceptive lessens menstrual irregularities and prevents pregnancies, to avoid exposure during pregnancy and the hypothetical risk of feminization of the male fetus with exposure late in the first trimester. “Early in my career, I used to say if you’re going to be on spironolactone you’re also going to be on an oral contraceptive. But the longer I’ve practiced, I’ve learned that women who have a contraindication to birth control pills or who don’t want to take it can still benefit from an oral antiandrogen by being on spironolactone.”

A large retrospective analysis of 14-year data concluded that routine potassium monitoring is unnecessary for healthy women taking spironolactone for acne. “If you’re between the ages of 18 and 45, healthy, and not taking other medications where I’m worried about potassium levels, I’m not checking those levels at all,” Dr. Harper said.

Spironolactone labeling includes a boxed warning regarding the potential for tumorigenicity based on rat studies, but the dosages used in those studies were 25-250 times higher than the exposure dose in humans, Dr. Harper said.

Results from a systematic review and meta-analysis of seven studies in the medical literature found no evidence of an increased risk of breast cancer in women with exposure to spironolactone. “However, the certainty of the evidence was low and future studies are needed, including among diverse populations such as younger individuals and those with acne or hirsutism,” the study authors wrote.



In a separate study, researchers drew from patients in the Humana Insurance database from 2005 to 2017 to address whether spironolactone is associated with an increased risk of recurrence of breast cancer. Recurrent breast cancer was examined in 29,146 women with continuous health insurance for 2 years after a diagnosis of breast cancer. Of these, 746 were prescribed spironolactone, and the remainder were not. The researchers found that 123 women (16.5%) who were prescribed spironolactone had a breast cancer recurrence, compared with 3,649 women (12.8%) with a breast cancer recurrence who had not been prescribed spironolactone (P = .004). Adjusted Cox regression analysis following propensity matching showed no association between spironolactone and increased breast cancer recurrence (adjusted hazard ratio, 0.966; P = .953).

According to Dr. Harper, spironolactone may take about 3 months to kick in. “Likely this is a long-term treatment, and most of the time we’re going to be using it in combination with other acne treatments such as topical retinoids or topical benzoyl peroxide, oral antibiotics, or even isotretinoin.”

A study of long-term spironolactone use in 403 women found that the most common dose prescribed was 100 mg/day, and 68% of the women were concurrently prescribed a topical retinoid, 2.2% an oral antibiotic, and 40.7% an oral contraceptive.

The study population included 32 patients with a history of polycystic ovarian syndrome, 1 with a history of breast cancer, and 5 were hypercoagulable. Patients took the drug for a mean of 471 days. “As opposed to our antibiotics, where the course for patients is generally 3-4 months, when you start someone on spironolactone, they may end up staying on it,” Dr. Harper said.

Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, Cassiopeia, Cutera, EPI, Galderma, L’Oreal, Ortho Dermatologics, Sol Gel, and Vyne. She also serves as a speaker or member of a speaker’s bureau for Almirall, Cassiopeia, Cutera, EPI, Galderma, Journey Almirall, L’Oreal, Ortho Dermatologics, Sun Pharmaceutical Industries, and Vyne.

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

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Spinosad: New kid on the block for treating scabies

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Changed
Wed, 04/05/2023 - 11:36

A new option for treating scabies, topical spinosad marks a significant development in the scabies treatment landscape, Anthony J. Mancini, MD, said during a presentation at the Hawaii Dermatology Seminar provided by MedscapeLIVE!

In April 2021, spinosad topical suspension 0.9%, was approved by the Food and Drug Administration for treating scabies infestations in adult and pediatric patients 4 years of age and older – a first-in-class drug and the first new scabicide approved in 31 years. It was also approved for treating head lice in adults and children aged 6 months of age and older.

Dr. Anthony J. Mancini
This image shows scabies papules and burrows on the soles.

“Scabies has been described as the worst itch one can experience,” said Dr. Mancini, professor of pediatrics and dermatology at Northwestern University, Chicago. “It’s a hallmark of the disease, it can persist for weeks, it’s most intense at night, and patients report various sensations. It’s believed to be a both type I and type IV hypersensitivity reaction.”

The microscopic scabies mite burrows into the upper layer of the skin where it lives and lays its eggs. Besides intense itching, the classic presentation consists of a skin rash composed of inflammatory papules, linear burrows and crusted papules (especially on the hands, feet, and groin), and at times, larger red nodules. “Scabies nodules can persist for many months,” he said.

The Global Burden of Disease Study 2015 cited scabies as having the greatest burden of disease in tropical regions, especially among children, adolescents, and the elderly. The greatest burden of disability-adjusted life years (DALYs) occurred in East and Southeast Asia, Oceana, and tropical South America, but in North America, there was a 24% increase in the DALY rate between 1990 and 2015.

In addition, the World Health Organization designated scabies as a neglected tropical disease in 2017 and included it in its 10-year road map for neglected tropical diseases 2021-2030 with goals of promoting disease awareness and encouraging research and achieving global control.

Dr. Anthony Mancini
Dr. Anthony J. Mancini

“In our country, we typically see scabies treated successfully without complications, but there can be complications, especially in underdeveloped areas, like Staph aureus and Group A beta-hemolytic streptococcal infections,” which can be fatal, said Dr. Mancini, who is also head of pediatric dermatology at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Permethrin 5% cream is typically offered as first-line topical therapy in the United States for the treatment of scabies. However, in vitro studies and small investigator-initiated in vivo studies have reported that efficacy appears to be decreasing. In one of the trials, Italian researchers enrolled 155 patients who were treated with permethrin 5% for 8 hours for 2 consecutive days and repeated the treatment 5 days later (J Eur Acad Dermatol Venereol. 2021;35[12]:e889-91). Following the course of permethrin, only 34 responded, 96 failed treatment, and 25 were lost to follow-up.

“The study authors concluded that mite resistance to permethrin 5% seems to be increasing, following a path like other ectoparasite resistance,” said Dr. Mancini, who was not involved with the study. “We may even be seeing more ivermectin resistance in some geographic locations, as well.”

According to new scabicide efficacy criteria established by the FDA in 2016, complete cure is now defined as meeting both clinical and confirmatory criteria. A clinical cure means that all signs and symptoms of scabies have completely resolved, including burrows, inflammatory/noninflammatory lesions, and pruritus. A confirmatory cure means there is an absence of mites, eggs, scybala (feces), and burrows via microscopy or dermoscopy.

Dr. Anthony J. Mancini
This microscopic image shows scabies eggs and scybala (feces).

Enter spinosad, which is derived from a naturally occurring soil microorganism known as Saccharopolyspora spinosa and is composed of two active molecules: spinosyn A and spinosyn D. According to Dr. Mancini, spinosad’s mechanism of action is unique from other medications used to treat ectoparasites. It activates nicotinic and GABA-gated sodium channels, leads to sodium influx in the insect nerves, hyperexcitation, then paralysis and death. Cross-resistance to other insecticides has not been reported, he added, and there is no known evidence of resistance to its active compound.

Approval of the drug was based on data from two phase 3 randomized clinical trials involving 551 index cases and household contacts. In the intent-to-treat population, with the two trials combined, complete cure was achieved in 78.1% of the spinosad-treated group, compared with 39.6% in the vehicle group (P < .0001), clinical cure was achieved in 79.6% of the spinosad group, compared with 41.2% in the vehicle group (P < .001), and microscopic cure occurred in 85.9% of the spinosad group, compared with 52.6% in the vehicle group (P < .001).

Of the 306 participants in the study, the only adverse events reported by more than one patient each included abdominal pain, back pain, cough, headache, neck pain, and decreased weight in two patients each (0.8%), which investigators believed were not attributable to the study drug. Adverse events that investigators considered to be potentially related to the study drug included burning sensation in two participants (0.7%) and dry skin in another (0.3%). In clinical trials reported in the prescribing information, adverse events occurring in greater than 1% of subjects included application-site irritation (3% spinosad vs. 0% vehicle) and dry skin (2% spinosad vs. 0% vehicle).



“Spinosad met the FDA’s new stringent criteria, with all signs and symptoms of scabies completely resolved and confirmed via microscopy or dermoscopy,” said Dr. Mancini, who was not involved in the trials. “The patented formulation drives the active compound to the stratum corneum, where mites live and breed. It’s a single full-body application, without any resistance observed to date. This is an exciting newer option for treating our scabies patients.”

In an interview at the meeting, John S. Barbieri, MD, MBA, of the department of dermatology, Brigham and Women’s Hospital, Boston, said that, while he has no clinical experience with spinosad for scabies, he welcomes a new option for the condition. “The fact that it has a different mechanism of action than permethrin is a good thing,” he said.

Dr. Mancini disclosed that he is a consultant or an adviser for ParaPRO, the manufacturer of spinosad, and Cassiopea, Castle Creek, Novan, Novartis, and Verrica. He was not involved in clinical trials of spinosad. Dr. Barbieri disclosed that he receives consulting fees from Dexcel.

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A new option for treating scabies, topical spinosad marks a significant development in the scabies treatment landscape, Anthony J. Mancini, MD, said during a presentation at the Hawaii Dermatology Seminar provided by MedscapeLIVE!

In April 2021, spinosad topical suspension 0.9%, was approved by the Food and Drug Administration for treating scabies infestations in adult and pediatric patients 4 years of age and older – a first-in-class drug and the first new scabicide approved in 31 years. It was also approved for treating head lice in adults and children aged 6 months of age and older.

Dr. Anthony J. Mancini
This image shows scabies papules and burrows on the soles.

“Scabies has been described as the worst itch one can experience,” said Dr. Mancini, professor of pediatrics and dermatology at Northwestern University, Chicago. “It’s a hallmark of the disease, it can persist for weeks, it’s most intense at night, and patients report various sensations. It’s believed to be a both type I and type IV hypersensitivity reaction.”

The microscopic scabies mite burrows into the upper layer of the skin where it lives and lays its eggs. Besides intense itching, the classic presentation consists of a skin rash composed of inflammatory papules, linear burrows and crusted papules (especially on the hands, feet, and groin), and at times, larger red nodules. “Scabies nodules can persist for many months,” he said.

The Global Burden of Disease Study 2015 cited scabies as having the greatest burden of disease in tropical regions, especially among children, adolescents, and the elderly. The greatest burden of disability-adjusted life years (DALYs) occurred in East and Southeast Asia, Oceana, and tropical South America, but in North America, there was a 24% increase in the DALY rate between 1990 and 2015.

In addition, the World Health Organization designated scabies as a neglected tropical disease in 2017 and included it in its 10-year road map for neglected tropical diseases 2021-2030 with goals of promoting disease awareness and encouraging research and achieving global control.

Dr. Anthony Mancini
Dr. Anthony J. Mancini

“In our country, we typically see scabies treated successfully without complications, but there can be complications, especially in underdeveloped areas, like Staph aureus and Group A beta-hemolytic streptococcal infections,” which can be fatal, said Dr. Mancini, who is also head of pediatric dermatology at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Permethrin 5% cream is typically offered as first-line topical therapy in the United States for the treatment of scabies. However, in vitro studies and small investigator-initiated in vivo studies have reported that efficacy appears to be decreasing. In one of the trials, Italian researchers enrolled 155 patients who were treated with permethrin 5% for 8 hours for 2 consecutive days and repeated the treatment 5 days later (J Eur Acad Dermatol Venereol. 2021;35[12]:e889-91). Following the course of permethrin, only 34 responded, 96 failed treatment, and 25 were lost to follow-up.

“The study authors concluded that mite resistance to permethrin 5% seems to be increasing, following a path like other ectoparasite resistance,” said Dr. Mancini, who was not involved with the study. “We may even be seeing more ivermectin resistance in some geographic locations, as well.”

According to new scabicide efficacy criteria established by the FDA in 2016, complete cure is now defined as meeting both clinical and confirmatory criteria. A clinical cure means that all signs and symptoms of scabies have completely resolved, including burrows, inflammatory/noninflammatory lesions, and pruritus. A confirmatory cure means there is an absence of mites, eggs, scybala (feces), and burrows via microscopy or dermoscopy.

Dr. Anthony J. Mancini
This microscopic image shows scabies eggs and scybala (feces).

Enter spinosad, which is derived from a naturally occurring soil microorganism known as Saccharopolyspora spinosa and is composed of two active molecules: spinosyn A and spinosyn D. According to Dr. Mancini, spinosad’s mechanism of action is unique from other medications used to treat ectoparasites. It activates nicotinic and GABA-gated sodium channels, leads to sodium influx in the insect nerves, hyperexcitation, then paralysis and death. Cross-resistance to other insecticides has not been reported, he added, and there is no known evidence of resistance to its active compound.

Approval of the drug was based on data from two phase 3 randomized clinical trials involving 551 index cases and household contacts. In the intent-to-treat population, with the two trials combined, complete cure was achieved in 78.1% of the spinosad-treated group, compared with 39.6% in the vehicle group (P < .0001), clinical cure was achieved in 79.6% of the spinosad group, compared with 41.2% in the vehicle group (P < .001), and microscopic cure occurred in 85.9% of the spinosad group, compared with 52.6% in the vehicle group (P < .001).

Of the 306 participants in the study, the only adverse events reported by more than one patient each included abdominal pain, back pain, cough, headache, neck pain, and decreased weight in two patients each (0.8%), which investigators believed were not attributable to the study drug. Adverse events that investigators considered to be potentially related to the study drug included burning sensation in two participants (0.7%) and dry skin in another (0.3%). In clinical trials reported in the prescribing information, adverse events occurring in greater than 1% of subjects included application-site irritation (3% spinosad vs. 0% vehicle) and dry skin (2% spinosad vs. 0% vehicle).



“Spinosad met the FDA’s new stringent criteria, with all signs and symptoms of scabies completely resolved and confirmed via microscopy or dermoscopy,” said Dr. Mancini, who was not involved in the trials. “The patented formulation drives the active compound to the stratum corneum, where mites live and breed. It’s a single full-body application, without any resistance observed to date. This is an exciting newer option for treating our scabies patients.”

In an interview at the meeting, John S. Barbieri, MD, MBA, of the department of dermatology, Brigham and Women’s Hospital, Boston, said that, while he has no clinical experience with spinosad for scabies, he welcomes a new option for the condition. “The fact that it has a different mechanism of action than permethrin is a good thing,” he said.

Dr. Mancini disclosed that he is a consultant or an adviser for ParaPRO, the manufacturer of spinosad, and Cassiopea, Castle Creek, Novan, Novartis, and Verrica. He was not involved in clinical trials of spinosad. Dr. Barbieri disclosed that he receives consulting fees from Dexcel.

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

A new option for treating scabies, topical spinosad marks a significant development in the scabies treatment landscape, Anthony J. Mancini, MD, said during a presentation at the Hawaii Dermatology Seminar provided by MedscapeLIVE!

In April 2021, spinosad topical suspension 0.9%, was approved by the Food and Drug Administration for treating scabies infestations in adult and pediatric patients 4 years of age and older – a first-in-class drug and the first new scabicide approved in 31 years. It was also approved for treating head lice in adults and children aged 6 months of age and older.

Dr. Anthony J. Mancini
This image shows scabies papules and burrows on the soles.

“Scabies has been described as the worst itch one can experience,” said Dr. Mancini, professor of pediatrics and dermatology at Northwestern University, Chicago. “It’s a hallmark of the disease, it can persist for weeks, it’s most intense at night, and patients report various sensations. It’s believed to be a both type I and type IV hypersensitivity reaction.”

The microscopic scabies mite burrows into the upper layer of the skin where it lives and lays its eggs. Besides intense itching, the classic presentation consists of a skin rash composed of inflammatory papules, linear burrows and crusted papules (especially on the hands, feet, and groin), and at times, larger red nodules. “Scabies nodules can persist for many months,” he said.

The Global Burden of Disease Study 2015 cited scabies as having the greatest burden of disease in tropical regions, especially among children, adolescents, and the elderly. The greatest burden of disability-adjusted life years (DALYs) occurred in East and Southeast Asia, Oceana, and tropical South America, but in North America, there was a 24% increase in the DALY rate between 1990 and 2015.

In addition, the World Health Organization designated scabies as a neglected tropical disease in 2017 and included it in its 10-year road map for neglected tropical diseases 2021-2030 with goals of promoting disease awareness and encouraging research and achieving global control.

Dr. Anthony Mancini
Dr. Anthony J. Mancini

“In our country, we typically see scabies treated successfully without complications, but there can be complications, especially in underdeveloped areas, like Staph aureus and Group A beta-hemolytic streptococcal infections,” which can be fatal, said Dr. Mancini, who is also head of pediatric dermatology at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Permethrin 5% cream is typically offered as first-line topical therapy in the United States for the treatment of scabies. However, in vitro studies and small investigator-initiated in vivo studies have reported that efficacy appears to be decreasing. In one of the trials, Italian researchers enrolled 155 patients who were treated with permethrin 5% for 8 hours for 2 consecutive days and repeated the treatment 5 days later (J Eur Acad Dermatol Venereol. 2021;35[12]:e889-91). Following the course of permethrin, only 34 responded, 96 failed treatment, and 25 were lost to follow-up.

“The study authors concluded that mite resistance to permethrin 5% seems to be increasing, following a path like other ectoparasite resistance,” said Dr. Mancini, who was not involved with the study. “We may even be seeing more ivermectin resistance in some geographic locations, as well.”

According to new scabicide efficacy criteria established by the FDA in 2016, complete cure is now defined as meeting both clinical and confirmatory criteria. A clinical cure means that all signs and symptoms of scabies have completely resolved, including burrows, inflammatory/noninflammatory lesions, and pruritus. A confirmatory cure means there is an absence of mites, eggs, scybala (feces), and burrows via microscopy or dermoscopy.

Dr. Anthony J. Mancini
This microscopic image shows scabies eggs and scybala (feces).

Enter spinosad, which is derived from a naturally occurring soil microorganism known as Saccharopolyspora spinosa and is composed of two active molecules: spinosyn A and spinosyn D. According to Dr. Mancini, spinosad’s mechanism of action is unique from other medications used to treat ectoparasites. It activates nicotinic and GABA-gated sodium channels, leads to sodium influx in the insect nerves, hyperexcitation, then paralysis and death. Cross-resistance to other insecticides has not been reported, he added, and there is no known evidence of resistance to its active compound.

Approval of the drug was based on data from two phase 3 randomized clinical trials involving 551 index cases and household contacts. In the intent-to-treat population, with the two trials combined, complete cure was achieved in 78.1% of the spinosad-treated group, compared with 39.6% in the vehicle group (P < .0001), clinical cure was achieved in 79.6% of the spinosad group, compared with 41.2% in the vehicle group (P < .001), and microscopic cure occurred in 85.9% of the spinosad group, compared with 52.6% in the vehicle group (P < .001).

Of the 306 participants in the study, the only adverse events reported by more than one patient each included abdominal pain, back pain, cough, headache, neck pain, and decreased weight in two patients each (0.8%), which investigators believed were not attributable to the study drug. Adverse events that investigators considered to be potentially related to the study drug included burning sensation in two participants (0.7%) and dry skin in another (0.3%). In clinical trials reported in the prescribing information, adverse events occurring in greater than 1% of subjects included application-site irritation (3% spinosad vs. 0% vehicle) and dry skin (2% spinosad vs. 0% vehicle).



“Spinosad met the FDA’s new stringent criteria, with all signs and symptoms of scabies completely resolved and confirmed via microscopy or dermoscopy,” said Dr. Mancini, who was not involved in the trials. “The patented formulation drives the active compound to the stratum corneum, where mites live and breed. It’s a single full-body application, without any resistance observed to date. This is an exciting newer option for treating our scabies patients.”

In an interview at the meeting, John S. Barbieri, MD, MBA, of the department of dermatology, Brigham and Women’s Hospital, Boston, said that, while he has no clinical experience with spinosad for scabies, he welcomes a new option for the condition. “The fact that it has a different mechanism of action than permethrin is a good thing,” he said.

Dr. Mancini disclosed that he is a consultant or an adviser for ParaPRO, the manufacturer of spinosad, and Cassiopea, Castle Creek, Novan, Novartis, and Verrica. He was not involved in clinical trials of spinosad. Dr. Barbieri disclosed that he receives consulting fees from Dexcel.

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

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Racial morphing: A conundrum in cosmetic dermatology

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Changed
Fri, 03/10/2023 - 10:43

– In the opinion of Nazanin A. Saedi, MD, social media-induced dissatisfaction with appearance is getting out of hand in the field of cosmetic dermatology, with the emergence of apps to filter and edit images to the patient’s liking.

This, coupled with the volume of celebrity images viewable on cable television and every social media platform, has led to racial morphing, a trend in which aesthetically modified faces have trended toward a similar look.

“Overexposure of celebrity images and altered faces on social media have led to a trend of overarching brows, sculpted noses, enlarged cheeks, and sharply defined jawlines,” Dr. Saedi, cochair of the laser and aesthetics surgery center at Dermatology Associates of Plymouth Meeting, Pa., said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “These trends have made people of different ethnicities morph into a similar appearance.”

Doug Brunk/MDedge News
Dr. Nazanin A. Saedi


At the meeting, she showed early career images of celebrities from different ethnic backgrounds, “and they all have unique features that make them look great,” said Dr. Saedi, clinical associate professor of dermatology at Thomas Jefferson University, Philadelphia. She then showed images of the same celebrities after they had undergone cosmetic procedures, “and they look so much more similar,” with overarched brows, sculpted noses, enlarged cheeks, and sharply defined jawlines. “Whereas they were all beautiful before individually, now they look very similar,” she said. “This is what we see on social media.”

Referring to the Kardashians as an example of celebrities who have had a lot of aesthetic treatments, look different than they did years ago, and are seen “more and more,” she added, “it’s this repeated overexposure to people on social media, to celebrities, that’s created this different trend of attractiveness.”

This trend also affects patients seeking cosmetic treatments, she noted. Individuals can use an app to alter their appearance, “changing the way they look to create the best version of themselves, they might say, or a filtered version of themselves,” said Dr. Saedi, one of the authors of a commentary on patient perception of beauty on social media published several years ago.

“I tell people, ‘Don’t use filters in your photos. Embrace your beauty.’ I have patients coming in who want to look like the social media photos they’ve curated, maybe larger lips or more definition in their jawline. What they don’t understand is that it takes a long time for that to happen. It’s a process.” In other cases, their desired outcome is not possible due to limits of their individual facial anatomy.



In a study published almost 20 years ago in the journal Perception, Irish researchers manipulated the familiarity of typical and distinctive faces to measure the effect on attractiveness. They found that episodic familiarity affects attractiveness ratings independently of general or structural familiarity.

“So, the more you saw a face, the more familiar that face was to you,” said Dr. Saedi, who was not involved with the study. “Over time, you felt that to be more attractive. I think that’s a lot of what’s going on in the trends that we’re seeing – both in real life and on social media. I do think we need to be more mindful of maintaining features that make an individual unique, while also maintaining their ethnic beauty.”

In an interview at the meeting, Jacqueline D. Watchmaker, MD, a board-certified cosmetic and medical dermatologist who practices in Scottsdale, Ariz., said that she identifies with the notion of racial morphing in her own clinical experience. “Patients come in and specifically ask for chiseled jawlines, high cheekbones, and bigger lips,” Dr. Watchmaker said. “It’s a tricky situation when they ask for [a treatment] you don’t think they need. I prefer a more staged approach to maintain their individuality while giving them a little bit of the aesthetic benefit that they’re looking for.”

Dr. Saedi disclosed ties with AbbVie, Aerolase, Allergan, Alma, Cartessa, Cynosure, Galderma Laboratories, LP, Grand Cosmetics, Revelle Aesthetics, and Revision Skincare. Dr. Watchmaker reported having no financial disclosures.

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

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– In the opinion of Nazanin A. Saedi, MD, social media-induced dissatisfaction with appearance is getting out of hand in the field of cosmetic dermatology, with the emergence of apps to filter and edit images to the patient’s liking.

This, coupled with the volume of celebrity images viewable on cable television and every social media platform, has led to racial morphing, a trend in which aesthetically modified faces have trended toward a similar look.

“Overexposure of celebrity images and altered faces on social media have led to a trend of overarching brows, sculpted noses, enlarged cheeks, and sharply defined jawlines,” Dr. Saedi, cochair of the laser and aesthetics surgery center at Dermatology Associates of Plymouth Meeting, Pa., said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “These trends have made people of different ethnicities morph into a similar appearance.”

Doug Brunk/MDedge News
Dr. Nazanin A. Saedi


At the meeting, she showed early career images of celebrities from different ethnic backgrounds, “and they all have unique features that make them look great,” said Dr. Saedi, clinical associate professor of dermatology at Thomas Jefferson University, Philadelphia. She then showed images of the same celebrities after they had undergone cosmetic procedures, “and they look so much more similar,” with overarched brows, sculpted noses, enlarged cheeks, and sharply defined jawlines. “Whereas they were all beautiful before individually, now they look very similar,” she said. “This is what we see on social media.”

Referring to the Kardashians as an example of celebrities who have had a lot of aesthetic treatments, look different than they did years ago, and are seen “more and more,” she added, “it’s this repeated overexposure to people on social media, to celebrities, that’s created this different trend of attractiveness.”

This trend also affects patients seeking cosmetic treatments, she noted. Individuals can use an app to alter their appearance, “changing the way they look to create the best version of themselves, they might say, or a filtered version of themselves,” said Dr. Saedi, one of the authors of a commentary on patient perception of beauty on social media published several years ago.

“I tell people, ‘Don’t use filters in your photos. Embrace your beauty.’ I have patients coming in who want to look like the social media photos they’ve curated, maybe larger lips or more definition in their jawline. What they don’t understand is that it takes a long time for that to happen. It’s a process.” In other cases, their desired outcome is not possible due to limits of their individual facial anatomy.



In a study published almost 20 years ago in the journal Perception, Irish researchers manipulated the familiarity of typical and distinctive faces to measure the effect on attractiveness. They found that episodic familiarity affects attractiveness ratings independently of general or structural familiarity.

“So, the more you saw a face, the more familiar that face was to you,” said Dr. Saedi, who was not involved with the study. “Over time, you felt that to be more attractive. I think that’s a lot of what’s going on in the trends that we’re seeing – both in real life and on social media. I do think we need to be more mindful of maintaining features that make an individual unique, while also maintaining their ethnic beauty.”

In an interview at the meeting, Jacqueline D. Watchmaker, MD, a board-certified cosmetic and medical dermatologist who practices in Scottsdale, Ariz., said that she identifies with the notion of racial morphing in her own clinical experience. “Patients come in and specifically ask for chiseled jawlines, high cheekbones, and bigger lips,” Dr. Watchmaker said. “It’s a tricky situation when they ask for [a treatment] you don’t think they need. I prefer a more staged approach to maintain their individuality while giving them a little bit of the aesthetic benefit that they’re looking for.”

Dr. Saedi disclosed ties with AbbVie, Aerolase, Allergan, Alma, Cartessa, Cynosure, Galderma Laboratories, LP, Grand Cosmetics, Revelle Aesthetics, and Revision Skincare. Dr. Watchmaker reported having no financial disclosures.

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

– In the opinion of Nazanin A. Saedi, MD, social media-induced dissatisfaction with appearance is getting out of hand in the field of cosmetic dermatology, with the emergence of apps to filter and edit images to the patient’s liking.

This, coupled with the volume of celebrity images viewable on cable television and every social media platform, has led to racial morphing, a trend in which aesthetically modified faces have trended toward a similar look.

“Overexposure of celebrity images and altered faces on social media have led to a trend of overarching brows, sculpted noses, enlarged cheeks, and sharply defined jawlines,” Dr. Saedi, cochair of the laser and aesthetics surgery center at Dermatology Associates of Plymouth Meeting, Pa., said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “These trends have made people of different ethnicities morph into a similar appearance.”

Doug Brunk/MDedge News
Dr. Nazanin A. Saedi


At the meeting, she showed early career images of celebrities from different ethnic backgrounds, “and they all have unique features that make them look great,” said Dr. Saedi, clinical associate professor of dermatology at Thomas Jefferson University, Philadelphia. She then showed images of the same celebrities after they had undergone cosmetic procedures, “and they look so much more similar,” with overarched brows, sculpted noses, enlarged cheeks, and sharply defined jawlines. “Whereas they were all beautiful before individually, now they look very similar,” she said. “This is what we see on social media.”

Referring to the Kardashians as an example of celebrities who have had a lot of aesthetic treatments, look different than they did years ago, and are seen “more and more,” she added, “it’s this repeated overexposure to people on social media, to celebrities, that’s created this different trend of attractiveness.”

This trend also affects patients seeking cosmetic treatments, she noted. Individuals can use an app to alter their appearance, “changing the way they look to create the best version of themselves, they might say, or a filtered version of themselves,” said Dr. Saedi, one of the authors of a commentary on patient perception of beauty on social media published several years ago.

“I tell people, ‘Don’t use filters in your photos. Embrace your beauty.’ I have patients coming in who want to look like the social media photos they’ve curated, maybe larger lips or more definition in their jawline. What they don’t understand is that it takes a long time for that to happen. It’s a process.” In other cases, their desired outcome is not possible due to limits of their individual facial anatomy.



In a study published almost 20 years ago in the journal Perception, Irish researchers manipulated the familiarity of typical and distinctive faces to measure the effect on attractiveness. They found that episodic familiarity affects attractiveness ratings independently of general or structural familiarity.

“So, the more you saw a face, the more familiar that face was to you,” said Dr. Saedi, who was not involved with the study. “Over time, you felt that to be more attractive. I think that’s a lot of what’s going on in the trends that we’re seeing – both in real life and on social media. I do think we need to be more mindful of maintaining features that make an individual unique, while also maintaining their ethnic beauty.”

In an interview at the meeting, Jacqueline D. Watchmaker, MD, a board-certified cosmetic and medical dermatologist who practices in Scottsdale, Ariz., said that she identifies with the notion of racial morphing in her own clinical experience. “Patients come in and specifically ask for chiseled jawlines, high cheekbones, and bigger lips,” Dr. Watchmaker said. “It’s a tricky situation when they ask for [a treatment] you don’t think they need. I prefer a more staged approach to maintain their individuality while giving them a little bit of the aesthetic benefit that they’re looking for.”

Dr. Saedi disclosed ties with AbbVie, Aerolase, Allergan, Alma, Cartessa, Cynosure, Galderma Laboratories, LP, Grand Cosmetics, Revelle Aesthetics, and Revision Skincare. Dr. Watchmaker reported having no financial disclosures.

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

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Be vigilant about suspected cases of measles, expert advises

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With so many kids missing childhood vaccinations during the acute phase of the COVID-19 pandemic, think measles in patients who present with high fever, cough, and a maculopapular eruption.

Dr. Adelaide Hebert

“Measles is one of the most contagious of human viruses, and we are seeing a resurgence,” Adelaide A. Hebert, MD, professor of dermatology and pediatrics, and chief of pediatric dermatology at the Universtiy of Texas, Houston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “This is a re-emerging viral infection that dermatologists must recognize. Measles often starts behind the ears, and the eruption can look a lot like a drug eruption,” she noted. “Many of my pediatric colleagues have never seen a case of measles before because we have had a vaccine since 1963. Measles can almost entirely be prevented with vaccination. You get herd immunity if both doses have been administered to 95% of the population.”

In 2021, the World Health Organization estimated that 25 million children worldwide missed the measles vaccine. This caused 9 million cases of measles and 128,000 deaths in 22 countries, mainly from viral pneumonia, secondary bacterial pneumonia, and postviral encephalitis. According to the Centers for Disease Control and Prevention, 1,274 measles cases occurred in 31 states in 2019, mostly in individuals who were not vaccinated against it. Reported cases fell to 13 in 2020 but rose to 49 cases in 2021 and to 121 cases in 2022. As of Feb. 28, 2023, three cases have been reported in the United States.

“Measles spreads through direct contact with an infected person and through airborne transmission,” said Dr. Hebert, who recommended an article published in The Lancet for background on the topic. “Unlike COVID-19, measles has not mutated, so the original measles vaccine will work very well.”

Common clinical signs of measles include a generalized, maculopapular eruption lasting for 3 days or more, a temperature above 101° F plus cough, coryza, or conjunctivitis. Confirmation of measles can be made by PCR for viral RNA. Clinicians can also send a blood draw to the state public health lab for analysis. The serologic standard is a fourfold rise or fall in IgG titer with a paired sample sent 10-14 days after the initial collection.

“You can administer immune globulin up to 6 days after exposure to potentially prevent measles or decrease severity [in] immunocompromised hosts not previously vaccinated,” she said. The recommended intramuscular dose is 0.5 mL/kg, up to a dose of 15 mL/kg. Treatment is supportive and focused on relieving common symptoms and providing nutritional support. Administration of vitamin A is currently recommended for all children with acute measles.



Vitamin A supplements are available either as capsules (50,000 IU; 100,000 IU; 200,000 IU) or in liquid form. Parenteral formulations are also available. “Capsules need to be cut open and the contents squeezed into the mouths of children younger than 2 years,” Dr. Hebert said. “Capsules have the advantage that they can be given to mothers for administration at home.”

The recommended dosage of vitamin A in children is as follows, she said:

  • Aged 12 months or older: 200,000 IU daily for 2 days.
  • Aged 6 to 11 months: 100,000 IU daily for 2 days.
  • Aged 6 months or younger: 50,000 IU daily for 2 days.

The American Academy of Pediatrics recommends a third dose given 2-4 weeks later to children with clinical signs and symptoms of vitamin A deficiency.

In an interview following the meeting, Moise L. Levy, MD, professor of internal medicine and pediatrics at the University of Texas, Austin, emphasized that when clinicians evaluate pediatric patients with viral symptoms such as fever, cough, and skin eruption, “measles should be in the differential diagnosis.” The 2022 uptick in measles cases “would be another reason to engage in regular vaccinations.”

Dr. Hebert disclosed that she is a consultant or advisor for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica.

Dr. Levy disclosed that he is consultant or advisor for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi-Genzyme.

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

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With so many kids missing childhood vaccinations during the acute phase of the COVID-19 pandemic, think measles in patients who present with high fever, cough, and a maculopapular eruption.

Dr. Adelaide Hebert

“Measles is one of the most contagious of human viruses, and we are seeing a resurgence,” Adelaide A. Hebert, MD, professor of dermatology and pediatrics, and chief of pediatric dermatology at the Universtiy of Texas, Houston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “This is a re-emerging viral infection that dermatologists must recognize. Measles often starts behind the ears, and the eruption can look a lot like a drug eruption,” she noted. “Many of my pediatric colleagues have never seen a case of measles before because we have had a vaccine since 1963. Measles can almost entirely be prevented with vaccination. You get herd immunity if both doses have been administered to 95% of the population.”

In 2021, the World Health Organization estimated that 25 million children worldwide missed the measles vaccine. This caused 9 million cases of measles and 128,000 deaths in 22 countries, mainly from viral pneumonia, secondary bacterial pneumonia, and postviral encephalitis. According to the Centers for Disease Control and Prevention, 1,274 measles cases occurred in 31 states in 2019, mostly in individuals who were not vaccinated against it. Reported cases fell to 13 in 2020 but rose to 49 cases in 2021 and to 121 cases in 2022. As of Feb. 28, 2023, three cases have been reported in the United States.

“Measles spreads through direct contact with an infected person and through airborne transmission,” said Dr. Hebert, who recommended an article published in The Lancet for background on the topic. “Unlike COVID-19, measles has not mutated, so the original measles vaccine will work very well.”

Common clinical signs of measles include a generalized, maculopapular eruption lasting for 3 days or more, a temperature above 101° F plus cough, coryza, or conjunctivitis. Confirmation of measles can be made by PCR for viral RNA. Clinicians can also send a blood draw to the state public health lab for analysis. The serologic standard is a fourfold rise or fall in IgG titer with a paired sample sent 10-14 days after the initial collection.

“You can administer immune globulin up to 6 days after exposure to potentially prevent measles or decrease severity [in] immunocompromised hosts not previously vaccinated,” she said. The recommended intramuscular dose is 0.5 mL/kg, up to a dose of 15 mL/kg. Treatment is supportive and focused on relieving common symptoms and providing nutritional support. Administration of vitamin A is currently recommended for all children with acute measles.



Vitamin A supplements are available either as capsules (50,000 IU; 100,000 IU; 200,000 IU) or in liquid form. Parenteral formulations are also available. “Capsules need to be cut open and the contents squeezed into the mouths of children younger than 2 years,” Dr. Hebert said. “Capsules have the advantage that they can be given to mothers for administration at home.”

The recommended dosage of vitamin A in children is as follows, she said:

  • Aged 12 months or older: 200,000 IU daily for 2 days.
  • Aged 6 to 11 months: 100,000 IU daily for 2 days.
  • Aged 6 months or younger: 50,000 IU daily for 2 days.

The American Academy of Pediatrics recommends a third dose given 2-4 weeks later to children with clinical signs and symptoms of vitamin A deficiency.

In an interview following the meeting, Moise L. Levy, MD, professor of internal medicine and pediatrics at the University of Texas, Austin, emphasized that when clinicians evaluate pediatric patients with viral symptoms such as fever, cough, and skin eruption, “measles should be in the differential diagnosis.” The 2022 uptick in measles cases “would be another reason to engage in regular vaccinations.”

Dr. Hebert disclosed that she is a consultant or advisor for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica.

Dr. Levy disclosed that he is consultant or advisor for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi-Genzyme.

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

With so many kids missing childhood vaccinations during the acute phase of the COVID-19 pandemic, think measles in patients who present with high fever, cough, and a maculopapular eruption.

Dr. Adelaide Hebert

“Measles is one of the most contagious of human viruses, and we are seeing a resurgence,” Adelaide A. Hebert, MD, professor of dermatology and pediatrics, and chief of pediatric dermatology at the Universtiy of Texas, Houston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “This is a re-emerging viral infection that dermatologists must recognize. Measles often starts behind the ears, and the eruption can look a lot like a drug eruption,” she noted. “Many of my pediatric colleagues have never seen a case of measles before because we have had a vaccine since 1963. Measles can almost entirely be prevented with vaccination. You get herd immunity if both doses have been administered to 95% of the population.”

In 2021, the World Health Organization estimated that 25 million children worldwide missed the measles vaccine. This caused 9 million cases of measles and 128,000 deaths in 22 countries, mainly from viral pneumonia, secondary bacterial pneumonia, and postviral encephalitis. According to the Centers for Disease Control and Prevention, 1,274 measles cases occurred in 31 states in 2019, mostly in individuals who were not vaccinated against it. Reported cases fell to 13 in 2020 but rose to 49 cases in 2021 and to 121 cases in 2022. As of Feb. 28, 2023, three cases have been reported in the United States.

“Measles spreads through direct contact with an infected person and through airborne transmission,” said Dr. Hebert, who recommended an article published in The Lancet for background on the topic. “Unlike COVID-19, measles has not mutated, so the original measles vaccine will work very well.”

Common clinical signs of measles include a generalized, maculopapular eruption lasting for 3 days or more, a temperature above 101° F plus cough, coryza, or conjunctivitis. Confirmation of measles can be made by PCR for viral RNA. Clinicians can also send a blood draw to the state public health lab for analysis. The serologic standard is a fourfold rise or fall in IgG titer with a paired sample sent 10-14 days after the initial collection.

“You can administer immune globulin up to 6 days after exposure to potentially prevent measles or decrease severity [in] immunocompromised hosts not previously vaccinated,” she said. The recommended intramuscular dose is 0.5 mL/kg, up to a dose of 15 mL/kg. Treatment is supportive and focused on relieving common symptoms and providing nutritional support. Administration of vitamin A is currently recommended for all children with acute measles.



Vitamin A supplements are available either as capsules (50,000 IU; 100,000 IU; 200,000 IU) or in liquid form. Parenteral formulations are also available. “Capsules need to be cut open and the contents squeezed into the mouths of children younger than 2 years,” Dr. Hebert said. “Capsules have the advantage that they can be given to mothers for administration at home.”

The recommended dosage of vitamin A in children is as follows, she said:

  • Aged 12 months or older: 200,000 IU daily for 2 days.
  • Aged 6 to 11 months: 100,000 IU daily for 2 days.
  • Aged 6 months or younger: 50,000 IU daily for 2 days.

The American Academy of Pediatrics recommends a third dose given 2-4 weeks later to children with clinical signs and symptoms of vitamin A deficiency.

In an interview following the meeting, Moise L. Levy, MD, professor of internal medicine and pediatrics at the University of Texas, Austin, emphasized that when clinicians evaluate pediatric patients with viral symptoms such as fever, cough, and skin eruption, “measles should be in the differential diagnosis.” The 2022 uptick in measles cases “would be another reason to engage in regular vaccinations.”

Dr. Hebert disclosed that she is a consultant or advisor for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica.

Dr. Levy disclosed that he is consultant or advisor for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi-Genzyme.

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

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Skin reactions from melanoma targeted and immune therapies range from pruritus to SJS

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Fri, 03/03/2023 - 15:09

– A downside of the revolutionary advances in targeted and immune therapies used to treat melanoma are their potential to trigger a wide range of skin reactions, from acneiform eruptions to Stevens-Johnson Syndrome (SJS).

“These skin reactions can cause pain, itching, and emotional and social distress that may severely impact activities of daily living,” Aleksandr Itkin, MD, a dermatologist at Scripps MD Anderson Cancer Center, San Diego, said at the annual Cutaneous Malignancy Update. An estimated 30%-50% of patients on immune checkpoint inhibitors (ICIs) experience cutaneous adverse events, he said, which leads to dose reduction or discontinuation of ICIs in 20% of cases.

Clinicians first observed these side effects in 2011, with the Food and Drug Administration approval of ipilimumab, a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)–blocking antibody, for metastatic melanoma, followed by the programmed death receptor-1 (PD-1) inhibitors nivolumab and pembrolizumab, which were approved in 2014 for the same indication.

Courtesy Dr. Aleksandr Itkin
Dr. Aleksandr Itkin

Since then, more ICIs showing similar adverse cutaneous reactions have been approved by the FDA. These include avelumab, atezolizumab in combination with cobimetinib and vemurafenib, and a combination of relatlimab, an anti-LAG-3 antibody, with nivolumab.

Among the targeted therapies, the BRAF inhibitors vemurafenib and dabrafenib alone or in combination with MAPK pathway inhibitors cobimetinib and trametinib, which are a first-line therapy for V600 BRAF mutated metastatic melanoma, are associated with their own set of cutaneous reactions. The oncolytic modified herpes simplex virus T-VEC (talimogene laherparepvec), approved by the FDA in 2015 for the treatment of unresectable stage IIIB-IV metastatic melanoma, also results in cutaneous reactions that have been found useful in assessing the therapeutic outcome of this agent.

According to a 2020 CME article on the dermatologic adverse events that occur after treatment initiation with ICIs, the time of onset of psoriasiform rash is within the first 3 weeks, maculopapular rash and pruritus in the first 4-6 weeks, lichenoid eruption in the first 7-12 weeks, and bullous pemphigoid in weeks 13-15. The most severe reactions – SJS, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) – usually occur after 2-3 months of treatment.

A subsequent retrospective cohort study of patients in the United States treated with ICIs for a variety of systemic malignancies and matched controls found that the ICI-treated group had a significantly higher incidence of pruritus, mucositis, erythroderma, maculopapular eruption, vitiligo, lichen planus, bullous pemphigoid, Grover disease, rash, other nonspecific eruptions, and drug eruption or other nonspecific drug reaction. Patients with melanoma and renal cell carcinoma and those receiving combination therapy were at a higher risk of cutaneous immune-related adverse events.

Another study, a prospective trial of 617 patients with various advanced cancers (including melanoma), found that both severe and mild skin toxicities were significantly associated with improved progression-free and overall survival.

According to Dr. Itkin, erythema multiforme, SJS, and TEN have been reported with anti-PD1, anti-CTLA4, and BRAF inhibitors. In TEN induced by vemurafenib, an in vitro analysis showed cross-activation of lymphocytes with dabrafenib and with sulfamethoxazole. “This means you that may want to avoid sulfonamides in patients with serious hypersensitivity to vemurafenib, and vice versa,” he said at the meeting hosted by Scripps MD Anderson Cancer Center.
 

 

 

Acneiform eruptions

In addition, the use of MAPK inhibitors can trigger acneiform eruptions. In one study, 77% of patients on trametinib developed acneiform eruption, but only 10% of those on trametinib in combination with dabrafenib developed acneiform eruption. “Inhibition of the MAPK pathway leads to decreased proliferative markers, further leading to decreased keratinocyte replication, increased inflammatory cytokine, apoptosis, thinning and abnormal epidermal differentiation, follicular rupture, and papule/pustule formation,” he said. For these cases, “treatment options are similar to what we use for regular acne except for here, use of systemic steroids is sometimes needed, especially in more severe cases. The reaction may be so severe as to lead to dose reduction or discontinuation of antineoplastic treatment.”

Effects on nail, hair

Paronychia and onycholysis are additional potential adverse events of MEK inhibitors and BRAF inhibitors alone or in combination, Dr. Itkin continued. Onycholysis is associated with dabrafenib alone or in combination with trametinib, while vemurafenib has been shown to induce acute paronychia and brittle nails. He said that secondary infections in these cases can be treated with the options familiar to dermatologists in their daily practice: oral doxycycline, azole antifungals, vinegar soaks, topical superpotent corticosteroids under occlusion, nail avulsion, and phenol nail matrix ablation.

Dr. Itkin noted that while PD-1 and PD-L1 inhibitors can cause hair repigmentation, CTLA-4 and PD-1 inhibitors are more likely to cause vitiligo. Appearance of vitiligo is regarded as a good prognostic factor in the treatment of melanoma with various checkpoint inhibitors alone or in combination with each other or with radiation therapy. “About 5% of melanoma patients treated with ipilimumab will develop vitiligo,” he said.

ICI-induced vitiligo differs from conventional vitiligo in that there is no family or personal history of autoimmunity; it presents as a flecked pattern of lesion on photo-exposed skin, and it lacks the Koebner phenomenon. In addition, induction of squamous neoplasms can occur with BRAF inhibitors, especially in patients with a high frequency of RAS mutations.

He said that coadministration of MEK inhibitors such as trametinib and cobimetinib may prevent induction of keratinocytic neoplasms.

Dr. Itkin reported having no relevant financial disclosures.

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– A downside of the revolutionary advances in targeted and immune therapies used to treat melanoma are their potential to trigger a wide range of skin reactions, from acneiform eruptions to Stevens-Johnson Syndrome (SJS).

“These skin reactions can cause pain, itching, and emotional and social distress that may severely impact activities of daily living,” Aleksandr Itkin, MD, a dermatologist at Scripps MD Anderson Cancer Center, San Diego, said at the annual Cutaneous Malignancy Update. An estimated 30%-50% of patients on immune checkpoint inhibitors (ICIs) experience cutaneous adverse events, he said, which leads to dose reduction or discontinuation of ICIs in 20% of cases.

Clinicians first observed these side effects in 2011, with the Food and Drug Administration approval of ipilimumab, a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)–blocking antibody, for metastatic melanoma, followed by the programmed death receptor-1 (PD-1) inhibitors nivolumab and pembrolizumab, which were approved in 2014 for the same indication.

Courtesy Dr. Aleksandr Itkin
Dr. Aleksandr Itkin

Since then, more ICIs showing similar adverse cutaneous reactions have been approved by the FDA. These include avelumab, atezolizumab in combination with cobimetinib and vemurafenib, and a combination of relatlimab, an anti-LAG-3 antibody, with nivolumab.

Among the targeted therapies, the BRAF inhibitors vemurafenib and dabrafenib alone or in combination with MAPK pathway inhibitors cobimetinib and trametinib, which are a first-line therapy for V600 BRAF mutated metastatic melanoma, are associated with their own set of cutaneous reactions. The oncolytic modified herpes simplex virus T-VEC (talimogene laherparepvec), approved by the FDA in 2015 for the treatment of unresectable stage IIIB-IV metastatic melanoma, also results in cutaneous reactions that have been found useful in assessing the therapeutic outcome of this agent.

According to a 2020 CME article on the dermatologic adverse events that occur after treatment initiation with ICIs, the time of onset of psoriasiform rash is within the first 3 weeks, maculopapular rash and pruritus in the first 4-6 weeks, lichenoid eruption in the first 7-12 weeks, and bullous pemphigoid in weeks 13-15. The most severe reactions – SJS, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) – usually occur after 2-3 months of treatment.

A subsequent retrospective cohort study of patients in the United States treated with ICIs for a variety of systemic malignancies and matched controls found that the ICI-treated group had a significantly higher incidence of pruritus, mucositis, erythroderma, maculopapular eruption, vitiligo, lichen planus, bullous pemphigoid, Grover disease, rash, other nonspecific eruptions, and drug eruption or other nonspecific drug reaction. Patients with melanoma and renal cell carcinoma and those receiving combination therapy were at a higher risk of cutaneous immune-related adverse events.

Another study, a prospective trial of 617 patients with various advanced cancers (including melanoma), found that both severe and mild skin toxicities were significantly associated with improved progression-free and overall survival.

According to Dr. Itkin, erythema multiforme, SJS, and TEN have been reported with anti-PD1, anti-CTLA4, and BRAF inhibitors. In TEN induced by vemurafenib, an in vitro analysis showed cross-activation of lymphocytes with dabrafenib and with sulfamethoxazole. “This means you that may want to avoid sulfonamides in patients with serious hypersensitivity to vemurafenib, and vice versa,” he said at the meeting hosted by Scripps MD Anderson Cancer Center.
 

 

 

Acneiform eruptions

In addition, the use of MAPK inhibitors can trigger acneiform eruptions. In one study, 77% of patients on trametinib developed acneiform eruption, but only 10% of those on trametinib in combination with dabrafenib developed acneiform eruption. “Inhibition of the MAPK pathway leads to decreased proliferative markers, further leading to decreased keratinocyte replication, increased inflammatory cytokine, apoptosis, thinning and abnormal epidermal differentiation, follicular rupture, and papule/pustule formation,” he said. For these cases, “treatment options are similar to what we use for regular acne except for here, use of systemic steroids is sometimes needed, especially in more severe cases. The reaction may be so severe as to lead to dose reduction or discontinuation of antineoplastic treatment.”

Effects on nail, hair

Paronychia and onycholysis are additional potential adverse events of MEK inhibitors and BRAF inhibitors alone or in combination, Dr. Itkin continued. Onycholysis is associated with dabrafenib alone or in combination with trametinib, while vemurafenib has been shown to induce acute paronychia and brittle nails. He said that secondary infections in these cases can be treated with the options familiar to dermatologists in their daily practice: oral doxycycline, azole antifungals, vinegar soaks, topical superpotent corticosteroids under occlusion, nail avulsion, and phenol nail matrix ablation.

Dr. Itkin noted that while PD-1 and PD-L1 inhibitors can cause hair repigmentation, CTLA-4 and PD-1 inhibitors are more likely to cause vitiligo. Appearance of vitiligo is regarded as a good prognostic factor in the treatment of melanoma with various checkpoint inhibitors alone or in combination with each other or with radiation therapy. “About 5% of melanoma patients treated with ipilimumab will develop vitiligo,” he said.

ICI-induced vitiligo differs from conventional vitiligo in that there is no family or personal history of autoimmunity; it presents as a flecked pattern of lesion on photo-exposed skin, and it lacks the Koebner phenomenon. In addition, induction of squamous neoplasms can occur with BRAF inhibitors, especially in patients with a high frequency of RAS mutations.

He said that coadministration of MEK inhibitors such as trametinib and cobimetinib may prevent induction of keratinocytic neoplasms.

Dr. Itkin reported having no relevant financial disclosures.

– A downside of the revolutionary advances in targeted and immune therapies used to treat melanoma are their potential to trigger a wide range of skin reactions, from acneiform eruptions to Stevens-Johnson Syndrome (SJS).

“These skin reactions can cause pain, itching, and emotional and social distress that may severely impact activities of daily living,” Aleksandr Itkin, MD, a dermatologist at Scripps MD Anderson Cancer Center, San Diego, said at the annual Cutaneous Malignancy Update. An estimated 30%-50% of patients on immune checkpoint inhibitors (ICIs) experience cutaneous adverse events, he said, which leads to dose reduction or discontinuation of ICIs in 20% of cases.

Clinicians first observed these side effects in 2011, with the Food and Drug Administration approval of ipilimumab, a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)–blocking antibody, for metastatic melanoma, followed by the programmed death receptor-1 (PD-1) inhibitors nivolumab and pembrolizumab, which were approved in 2014 for the same indication.

Courtesy Dr. Aleksandr Itkin
Dr. Aleksandr Itkin

Since then, more ICIs showing similar adverse cutaneous reactions have been approved by the FDA. These include avelumab, atezolizumab in combination with cobimetinib and vemurafenib, and a combination of relatlimab, an anti-LAG-3 antibody, with nivolumab.

Among the targeted therapies, the BRAF inhibitors vemurafenib and dabrafenib alone or in combination with MAPK pathway inhibitors cobimetinib and trametinib, which are a first-line therapy for V600 BRAF mutated metastatic melanoma, are associated with their own set of cutaneous reactions. The oncolytic modified herpes simplex virus T-VEC (talimogene laherparepvec), approved by the FDA in 2015 for the treatment of unresectable stage IIIB-IV metastatic melanoma, also results in cutaneous reactions that have been found useful in assessing the therapeutic outcome of this agent.

According to a 2020 CME article on the dermatologic adverse events that occur after treatment initiation with ICIs, the time of onset of psoriasiform rash is within the first 3 weeks, maculopapular rash and pruritus in the first 4-6 weeks, lichenoid eruption in the first 7-12 weeks, and bullous pemphigoid in weeks 13-15. The most severe reactions – SJS, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) – usually occur after 2-3 months of treatment.

A subsequent retrospective cohort study of patients in the United States treated with ICIs for a variety of systemic malignancies and matched controls found that the ICI-treated group had a significantly higher incidence of pruritus, mucositis, erythroderma, maculopapular eruption, vitiligo, lichen planus, bullous pemphigoid, Grover disease, rash, other nonspecific eruptions, and drug eruption or other nonspecific drug reaction. Patients with melanoma and renal cell carcinoma and those receiving combination therapy were at a higher risk of cutaneous immune-related adverse events.

Another study, a prospective trial of 617 patients with various advanced cancers (including melanoma), found that both severe and mild skin toxicities were significantly associated with improved progression-free and overall survival.

According to Dr. Itkin, erythema multiforme, SJS, and TEN have been reported with anti-PD1, anti-CTLA4, and BRAF inhibitors. In TEN induced by vemurafenib, an in vitro analysis showed cross-activation of lymphocytes with dabrafenib and with sulfamethoxazole. “This means you that may want to avoid sulfonamides in patients with serious hypersensitivity to vemurafenib, and vice versa,” he said at the meeting hosted by Scripps MD Anderson Cancer Center.
 

 

 

Acneiform eruptions

In addition, the use of MAPK inhibitors can trigger acneiform eruptions. In one study, 77% of patients on trametinib developed acneiform eruption, but only 10% of those on trametinib in combination with dabrafenib developed acneiform eruption. “Inhibition of the MAPK pathway leads to decreased proliferative markers, further leading to decreased keratinocyte replication, increased inflammatory cytokine, apoptosis, thinning and abnormal epidermal differentiation, follicular rupture, and papule/pustule formation,” he said. For these cases, “treatment options are similar to what we use for regular acne except for here, use of systemic steroids is sometimes needed, especially in more severe cases. The reaction may be so severe as to lead to dose reduction or discontinuation of antineoplastic treatment.”

Effects on nail, hair

Paronychia and onycholysis are additional potential adverse events of MEK inhibitors and BRAF inhibitors alone or in combination, Dr. Itkin continued. Onycholysis is associated with dabrafenib alone or in combination with trametinib, while vemurafenib has been shown to induce acute paronychia and brittle nails. He said that secondary infections in these cases can be treated with the options familiar to dermatologists in their daily practice: oral doxycycline, azole antifungals, vinegar soaks, topical superpotent corticosteroids under occlusion, nail avulsion, and phenol nail matrix ablation.

Dr. Itkin noted that while PD-1 and PD-L1 inhibitors can cause hair repigmentation, CTLA-4 and PD-1 inhibitors are more likely to cause vitiligo. Appearance of vitiligo is regarded as a good prognostic factor in the treatment of melanoma with various checkpoint inhibitors alone or in combination with each other or with radiation therapy. “About 5% of melanoma patients treated with ipilimumab will develop vitiligo,” he said.

ICI-induced vitiligo differs from conventional vitiligo in that there is no family or personal history of autoimmunity; it presents as a flecked pattern of lesion on photo-exposed skin, and it lacks the Koebner phenomenon. In addition, induction of squamous neoplasms can occur with BRAF inhibitors, especially in patients with a high frequency of RAS mutations.

He said that coadministration of MEK inhibitors such as trametinib and cobimetinib may prevent induction of keratinocytic neoplasms.

Dr. Itkin reported having no relevant financial disclosures.

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Expert dispels myths about hair care in patients with skin of color

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Nearly every day, Candrice R. Heath, MD, spends time during office visits dispelling myths about hair care practices in patients with skin of color. One myth is the idea that not washing hair helps it to grow.

“This is false,” Dr. Heath, director of pediatric dermatology at Temple University, Philadelphia, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! With little manipulation, length may be retained, since tightly coiled hair has a higher likelihood of breakage, she said. “But washing the scalp and hair is recommended for tightly coiled hair weekly or every other week. Exclusively co-washing – a technique where hair conditioner is used instead of shampooing – is also not advised due to scalp build-up.”

JGI/Jamie Grill/Getty Images

Other myths she addressed include the following:

“I have a weak spot (or stress spot) on the top of my scalp.” These terms may be used to describe hair on a spot that goes through cycles of breaking off and re-growing. This is false. “If someone were to say that, and we see short hairs on the top of a patient’s scalp, with or without tenderness, pruritus, or pain, we want to recognize that as possibly an early sign of central centrifugal cicatricial alopecia [CCCA],” she said. “We want to pick up cases of CCCA forme fruste [central hair breakage] early.”



Medicated shampoos are helpful for all patients with seborrheic dermatitis. This notion is more complicated. “In theory, medicated shampoos like ketoconazole should be helpful, but if the shampoos are too drying for the hair and they cause further hair breakage, that’s going to be a problem as well,” explained Dr. Heath, who was the senior author of an article on how to address common conditions affecting pediatric and adolescent patients with skin of color. For patients with tightly coiled hair, she recommends applying antifungal shampoos to the scalp only, waiting 5-10 minutes, rinsing, and shampooing the scalp and hair with a moisturizing shampoo and rinsing. They can then condition with a moisturizing conditioner and style their hair as desired.

Dr. Candrice R. Heath


Don’t touch a Black woman’s hair. That unwritten rule may apply to a woman you pass on the street, she said, but not during clinical exams in cases where clinicians and patients seeking hair loss treatment have different hair types. “Touch the hair; don’t do a lean-in exam,” emphasized Dr. Heath, who is the inaugural faculty scholar at Temple University Lewis Katz School of Medicine’s Office of Health Equity Diversity, and Inclusion. “You want to perform the scalp and hair exam with cultural humility.” Understanding the patient’s hair care goals and perspective allows dermatologists to take a more individualized approach to their concerns, especially in race-discordant patient-physician interactions.

Going natural (chemical-free) will solve scarring hair loss problems. This is false. “Genetic defects in the hair shaft have been described as the cause of some CCCA cases, so we need to stop solely blaming the patient for that condition,” she said. Dr. Heath noted that the transition point between natural hair and relaxed hair is highly prone to breakage. She suggests low or lower tension options such as knotless braids, and crochet hairstyles, and when patients have locs, they should be shoulder length or higher to reduce tension.

Dr. Heath disclosed that she has served as a consultant or adviser for Arcutis, CeraVe, Janssen Pharmaceuticals, Johnson & Johnson Pharmaceutical Research & Development, Leo, Lilly, Pfizer, and Regeneron Pharmaceuticals.

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

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Nearly every day, Candrice R. Heath, MD, spends time during office visits dispelling myths about hair care practices in patients with skin of color. One myth is the idea that not washing hair helps it to grow.

“This is false,” Dr. Heath, director of pediatric dermatology at Temple University, Philadelphia, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! With little manipulation, length may be retained, since tightly coiled hair has a higher likelihood of breakage, she said. “But washing the scalp and hair is recommended for tightly coiled hair weekly or every other week. Exclusively co-washing – a technique where hair conditioner is used instead of shampooing – is also not advised due to scalp build-up.”

JGI/Jamie Grill/Getty Images

Other myths she addressed include the following:

“I have a weak spot (or stress spot) on the top of my scalp.” These terms may be used to describe hair on a spot that goes through cycles of breaking off and re-growing. This is false. “If someone were to say that, and we see short hairs on the top of a patient’s scalp, with or without tenderness, pruritus, or pain, we want to recognize that as possibly an early sign of central centrifugal cicatricial alopecia [CCCA],” she said. “We want to pick up cases of CCCA forme fruste [central hair breakage] early.”



Medicated shampoos are helpful for all patients with seborrheic dermatitis. This notion is more complicated. “In theory, medicated shampoos like ketoconazole should be helpful, but if the shampoos are too drying for the hair and they cause further hair breakage, that’s going to be a problem as well,” explained Dr. Heath, who was the senior author of an article on how to address common conditions affecting pediatric and adolescent patients with skin of color. For patients with tightly coiled hair, she recommends applying antifungal shampoos to the scalp only, waiting 5-10 minutes, rinsing, and shampooing the scalp and hair with a moisturizing shampoo and rinsing. They can then condition with a moisturizing conditioner and style their hair as desired.

Dr. Candrice R. Heath


Don’t touch a Black woman’s hair. That unwritten rule may apply to a woman you pass on the street, she said, but not during clinical exams in cases where clinicians and patients seeking hair loss treatment have different hair types. “Touch the hair; don’t do a lean-in exam,” emphasized Dr. Heath, who is the inaugural faculty scholar at Temple University Lewis Katz School of Medicine’s Office of Health Equity Diversity, and Inclusion. “You want to perform the scalp and hair exam with cultural humility.” Understanding the patient’s hair care goals and perspective allows dermatologists to take a more individualized approach to their concerns, especially in race-discordant patient-physician interactions.

Going natural (chemical-free) will solve scarring hair loss problems. This is false. “Genetic defects in the hair shaft have been described as the cause of some CCCA cases, so we need to stop solely blaming the patient for that condition,” she said. Dr. Heath noted that the transition point between natural hair and relaxed hair is highly prone to breakage. She suggests low or lower tension options such as knotless braids, and crochet hairstyles, and when patients have locs, they should be shoulder length or higher to reduce tension.

Dr. Heath disclosed that she has served as a consultant or adviser for Arcutis, CeraVe, Janssen Pharmaceuticals, Johnson & Johnson Pharmaceutical Research & Development, Leo, Lilly, Pfizer, and Regeneron Pharmaceuticals.

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

Nearly every day, Candrice R. Heath, MD, spends time during office visits dispelling myths about hair care practices in patients with skin of color. One myth is the idea that not washing hair helps it to grow.

“This is false,” Dr. Heath, director of pediatric dermatology at Temple University, Philadelphia, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! With little manipulation, length may be retained, since tightly coiled hair has a higher likelihood of breakage, she said. “But washing the scalp and hair is recommended for tightly coiled hair weekly or every other week. Exclusively co-washing – a technique where hair conditioner is used instead of shampooing – is also not advised due to scalp build-up.”

JGI/Jamie Grill/Getty Images

Other myths she addressed include the following:

“I have a weak spot (or stress spot) on the top of my scalp.” These terms may be used to describe hair on a spot that goes through cycles of breaking off and re-growing. This is false. “If someone were to say that, and we see short hairs on the top of a patient’s scalp, with or without tenderness, pruritus, or pain, we want to recognize that as possibly an early sign of central centrifugal cicatricial alopecia [CCCA],” she said. “We want to pick up cases of CCCA forme fruste [central hair breakage] early.”



Medicated shampoos are helpful for all patients with seborrheic dermatitis. This notion is more complicated. “In theory, medicated shampoos like ketoconazole should be helpful, but if the shampoos are too drying for the hair and they cause further hair breakage, that’s going to be a problem as well,” explained Dr. Heath, who was the senior author of an article on how to address common conditions affecting pediatric and adolescent patients with skin of color. For patients with tightly coiled hair, she recommends applying antifungal shampoos to the scalp only, waiting 5-10 minutes, rinsing, and shampooing the scalp and hair with a moisturizing shampoo and rinsing. They can then condition with a moisturizing conditioner and style their hair as desired.

Dr. Candrice R. Heath


Don’t touch a Black woman’s hair. That unwritten rule may apply to a woman you pass on the street, she said, but not during clinical exams in cases where clinicians and patients seeking hair loss treatment have different hair types. “Touch the hair; don’t do a lean-in exam,” emphasized Dr. Heath, who is the inaugural faculty scholar at Temple University Lewis Katz School of Medicine’s Office of Health Equity Diversity, and Inclusion. “You want to perform the scalp and hair exam with cultural humility.” Understanding the patient’s hair care goals and perspective allows dermatologists to take a more individualized approach to their concerns, especially in race-discordant patient-physician interactions.

Going natural (chemical-free) will solve scarring hair loss problems. This is false. “Genetic defects in the hair shaft have been described as the cause of some CCCA cases, so we need to stop solely blaming the patient for that condition,” she said. Dr. Heath noted that the transition point between natural hair and relaxed hair is highly prone to breakage. She suggests low or lower tension options such as knotless braids, and crochet hairstyles, and when patients have locs, they should be shoulder length or higher to reduce tension.

Dr. Heath disclosed that she has served as a consultant or adviser for Arcutis, CeraVe, Janssen Pharmaceuticals, Johnson & Johnson Pharmaceutical Research & Development, Leo, Lilly, Pfizer, and Regeneron Pharmaceuticals.

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

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