Dermatology

BY DEEPA VARMA

TOPLINE:

In patients with polycystic ovary syndrome (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve hirsutism and psychological well-being in women, according to the results of a systematic review.

METHODOLOGY:

• Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers, despite its significant psychological repercussions, including diminished self-esteem, reduced quality of life, and heightened depression.
• The 2023 international evidence-based PCOS guideline considers managing hirsutism a priority in women with PCOS.
• Researchers reviewed six studies (four randomized controlled trials and two cohort studies), which included 423 patients with PCOS who underwent laser or light-based hair reduction therapies, published through 2022.
• The studies evaluated the alexandrite laser, diode laser, and intense pulsed light (IPL) therapy, with and without pharmacological treatments. The main outcomes were hirsutism severity, psychological outcome, and adverse events.

TAKEAWAY:

• Alexandrite laser (wavelength, 755 nm) showed effective hair reduction and improved patient satisfaction (one study); high-fluence treatment yielded better outcomes than low-fluence treatment (one study). Alexandrite laser 755 nm also showed longer hair-free intervals and greater hair reduction than IPL therapy at 650-1000 nm (one study).
• Combined IPL (600 nm) and metformin therapy improved hirsutism and hair count reduction compared with IPL alone, but with more side effects (one study).
• Diode laser treatments (810 nm) with combined oral contraceptives improved hirsutism and related quality of life measures compared with diode laser alone or with metformin (one study).
• Comparing two diode lasers (wavelengths, 810 nm), low-fluence, high repetition laser showed superior hair width reduction and lower pain scores than high fluence, low-repetition laser (one study).

IN PRACTICE:

Laser and light treatments alone or combined with other treatments have demonstrated “encouraging results in reducing hirsutism severity, enhancing psychological well-being, and improving overall quality of life for affected individuals,” the authors wrote, noting that additional high-quality trials evaluating these treatments, which include more patients with different skin tones, are needed.

SOURCE:

The first author of the review is Katrina Tan, MD, Monash Health, Department of Dermatology, Melbourne, Victoria, Australia, and it was published online in JAMA Dermatology.

LIMITATIONS:

Limitations include low certainty of evidence because of the observational nature of some of the studies, the small number of studies, and underrepresentation of darker skin types, limiting generalizability.

DISCLOSURES:

The review is part of an update to the PCOS guideline, which was funded by the Australian National Health and Medical Research Council through various organizations. Several authors reported receiving grants and personal fees outside this work. Dr. Tan was a member of the 2023 PCOS guideline evidence team. Other authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

BY DEEPA VARMA

TOPLINE:

In patients with polycystic ovary syndrome (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve hirsutism and psychological well-being in women, according to the results of a systematic review.

METHODOLOGY:

• Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers, despite its significant psychological repercussions, including diminished self-esteem, reduced quality of life, and heightened depression.
• The 2023 international evidence-based PCOS guideline considers managing hirsutism a priority in women with PCOS.
• Researchers reviewed six studies (four randomized controlled trials and two cohort studies), which included 423 patients with PCOS who underwent laser or light-based hair reduction therapies, published through 2022.
• The studies evaluated the alexandrite laser, diode laser, and intense pulsed light (IPL) therapy, with and without pharmacological treatments. The main outcomes were hirsutism severity, psychological outcome, and adverse events.

TAKEAWAY:

• Alexandrite laser (wavelength, 755 nm) showed effective hair reduction and improved patient satisfaction (one study); high-fluence treatment yielded better outcomes than low-fluence treatment (one study). Alexandrite laser 755 nm also showed longer hair-free intervals and greater hair reduction than IPL therapy at 650-1000 nm (one study).
• Combined IPL (600 nm) and metformin therapy improved hirsutism and hair count reduction compared with IPL alone, but with more side effects (one study).
• Diode laser treatments (810 nm) with combined oral contraceptives improved hirsutism and related quality of life measures compared with diode laser alone or with metformin (one study).
• Comparing two diode lasers (wavelengths, 810 nm), low-fluence, high repetition laser showed superior hair width reduction and lower pain scores than high fluence, low-repetition laser (one study).

IN PRACTICE:

Laser and light treatments alone or combined with other treatments have demonstrated “encouraging results in reducing hirsutism severity, enhancing psychological well-being, and improving overall quality of life for affected individuals,” the authors wrote, noting that additional high-quality trials evaluating these treatments, which include more patients with different skin tones, are needed.

SOURCE:

The first author of the review is Katrina Tan, MD, Monash Health, Department of Dermatology, Melbourne, Victoria, Australia, and it was published online in JAMA Dermatology.

LIMITATIONS:

Limitations include low certainty of evidence because of the observational nature of some of the studies, the small number of studies, and underrepresentation of darker skin types, limiting generalizability.

DISCLOSURES:

The review is part of an update to the PCOS guideline, which was funded by the Australian National Health and Medical Research Council through various organizations. Several authors reported receiving grants and personal fees outside this work. Dr. Tan was a member of the 2023 PCOS guideline evidence team. Other authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

BY DEEPA VARMA

TOPLINE:

In patients with polycystic ovary syndrome (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve hirsutism and psychological well-being in women, according to the results of a systematic review.

METHODOLOGY:

• Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers, despite its significant psychological repercussions, including diminished self-esteem, reduced quality of life, and heightened depression.
• The 2023 international evidence-based PCOS guideline considers managing hirsutism a priority in women with PCOS.
• Researchers reviewed six studies (four randomized controlled trials and two cohort studies), which included 423 patients with PCOS who underwent laser or light-based hair reduction therapies, published through 2022.
• The studies evaluated the alexandrite laser, diode laser, and intense pulsed light (IPL) therapy, with and without pharmacological treatments. The main outcomes were hirsutism severity, psychological outcome, and adverse events.

TAKEAWAY:

• Alexandrite laser (wavelength, 755 nm) showed effective hair reduction and improved patient satisfaction (one study); high-fluence treatment yielded better outcomes than low-fluence treatment (one study). Alexandrite laser 755 nm also showed longer hair-free intervals and greater hair reduction than IPL therapy at 650-1000 nm (one study).
• Combined IPL (600 nm) and metformin therapy improved hirsutism and hair count reduction compared with IPL alone, but with more side effects (one study).
• Diode laser treatments (810 nm) with combined oral contraceptives improved hirsutism and related quality of life measures compared with diode laser alone or with metformin (one study).
• Comparing two diode lasers (wavelengths, 810 nm), low-fluence, high repetition laser showed superior hair width reduction and lower pain scores than high fluence, low-repetition laser (one study).

IN PRACTICE:

Laser and light treatments alone or combined with other treatments have demonstrated “encouraging results in reducing hirsutism severity, enhancing psychological well-being, and improving overall quality of life for affected individuals,” the authors wrote, noting that additional high-quality trials evaluating these treatments, which include more patients with different skin tones, are needed.

SOURCE:

The first author of the review is Katrina Tan, MD, Monash Health, Department of Dermatology, Melbourne, Victoria, Australia, and it was published online in JAMA Dermatology.

LIMITATIONS:

Limitations include low certainty of evidence because of the observational nature of some of the studies, the small number of studies, and underrepresentation of darker skin types, limiting generalizability.

DISCLOSURES:

The review is part of an update to the PCOS guideline, which was funded by the Australian National Health and Medical Research Council through various organizations. Several authors reported receiving grants and personal fees outside this work. Dr. Tan was a member of the 2023 PCOS guideline evidence team. Other authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

SAN DIEGO — Whether you completed your dermatology residency training 20 years ago or 2 years ago, recent advances in treatments for atopic dermatitis (AD) have likely influenced your “go to” interventions when treating children with AD, according to Lawrence F. Eichenfield, MD.

“There have been many changes in the understanding of AD and recognition of the variable courses of the disease, and the associated allergic and nonallergic comorbidities,” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego in California, said at the Society for Pediatric Dermatology meeting, held the day before the annual meeting of the American Academy of Dermatology. “With our revolutionary systemic and evolving topical therapies, we are in a new day of pediatric management.”

LucaLorenzelli/Thinkstock

Drawing from 2023 American Academy of Dermatology guidelines of care on topical treatments of AD and his own clinical experience, he shared his perspective on “what’s tried and true” in care for patients with persistent eczema:

Both bathing and moisturizing leave skin moist. It’s well established that the use of moisturizers/emollients minimizes xerosis and the amount of prescription anti-inflammatory medications, but limited evidence exists to recommend a particular ingredient and formulation, said Dr. Eichenfield, also professor of dermatology and pediatrics at the University of California, San Diego. “Future studies may tell us whether specific moisturizers work better than others, and/or if early interventions may prevent AD, but that remains a big question mark,” he noted. In addition, applications may sometimes “mobilize” topical prescriptive residual absorption and activity.

As for baths, he said, “avoidance of bathing to avoid drying out skin is a practice without evidence basis. Bathing also may have many benefits in active eczema.”

Bleach baths may enhance skin barrier function, reduce itch, and improve eczema, but the practice remains controversial, he continued. Authors of a systematic review and meta-analysis concluded that while bleach baths are effective in reducing the severity of AD, they do not appear to be more effective than water bath alone. Authors of a more recent study found that bleach baths did not normalize dysbiosis, “but that study did not compare outcomes to bathing without bleach,” Dr. Eichenfield noted.“My sense is there is some benefit to regular bathing, especially in children with moderate to severe AD, especially those with colonized or infected eczema.”

He advises clinicians to be aware of other “standard AD interventions” from around the world, including black tea wet dressings and green tea bath therapy.


 

Courtesy University of California, San Diego

Topical corticosteroids. These are “tried and true” for their anti-inflammatory properties and rapid response, relatively low cost, and large range of potency, he said. Potential problems include the burden of topical application and the potential for stinging/burning, atrophy, telangiectasias, adrenal axis suppression, and concerns about withdrawal phenomena. “Being a proponent of topical corticosteroids, but explaining reasonable and appropriate use can be challenging,” Dr. Eichenfield said. “Social media has influenced concerns about topical corticosteroids, with steroid addiction and withdrawal being concerns influencing discomfort with therapies.”

Make sure to measure outcomes. The suggested core outcome measure for recording clinical signs in AD clinical trials is the Eczema Area and Severity Index (EASI) score, he said. In clinical practice, Dr. Eichenfield favors body surface area (BSA) and the Validated Global Assessment scale (v-IGA) to measure signs of moderate to severe AD. “Documenting extent of disease makes a big difference in families understanding how severe their child’s disease is and how it is doing over time.” Alternatively, he recommends the Atopic Dermatitis Control Tool (ADCT) or the Recap of Atopic Eczema (RECAP) as tools assessing long-term disease control.

Familiarize yourself with nonsteroidal anti-inflammatory medications for care regimens. Options include topical calcineurin inhibitors (TCIs) such as tacrolimus and pimecrolimus; phosphodiesterase 4 (PDE-4) inhibitors such as crisaborole and roflumilast; the aryl-hydrocarbon receptor agonist tapinarof; and topical Janus kinase (JAK) inhibitors such as delgocitinib and ruxolitinib as well as others in development. “There is variable status around the world in terms of whether these nonsteroidal options are approved or not,” Dr. Eichenfield said. “Issues of use include cost, availability, side effects, and concerns about potential absorption. I think there’s an evolution in how much we rely on these instead of topical corticosteroids. They’re more commonly used in maintenance regimens rather than for remission induction.”

Dr. Eichenfield encouraged dermatologists to share information about and experiences with evolving treatment options for AD, “because when the studies are done, they are done as monotherapy. We must translate that into clinical practice and figure out how they fit in. Our exchange of information is critical.”

Dr. Eichenfield disclosed conflicts of interest from many pharmaceutical companies, including those with AD treatments.

SAN DIEGO — Whether you completed your dermatology residency training 20 years ago or 2 years ago, recent advances in treatments for atopic dermatitis (AD) have likely influenced your “go to” interventions when treating children with AD, according to Lawrence F. Eichenfield, MD.

“There have been many changes in the understanding of AD and recognition of the variable courses of the disease, and the associated allergic and nonallergic comorbidities,” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego in California, said at the Society for Pediatric Dermatology meeting, held the day before the annual meeting of the American Academy of Dermatology. “With our revolutionary systemic and evolving topical therapies, we are in a new day of pediatric management.”

LucaLorenzelli/Thinkstock

Drawing from 2023 American Academy of Dermatology guidelines of care on topical treatments of AD and his own clinical experience, he shared his perspective on “what’s tried and true” in care for patients with persistent eczema:

Both bathing and moisturizing leave skin moist. It’s well established that the use of moisturizers/emollients minimizes xerosis and the amount of prescription anti-inflammatory medications, but limited evidence exists to recommend a particular ingredient and formulation, said Dr. Eichenfield, also professor of dermatology and pediatrics at the University of California, San Diego. “Future studies may tell us whether specific moisturizers work better than others, and/or if early interventions may prevent AD, but that remains a big question mark,” he noted. In addition, applications may sometimes “mobilize” topical prescriptive residual absorption and activity.

As for baths, he said, “avoidance of bathing to avoid drying out skin is a practice without evidence basis. Bathing also may have many benefits in active eczema.”

Bleach baths may enhance skin barrier function, reduce itch, and improve eczema, but the practice remains controversial, he continued. Authors of a systematic review and meta-analysis concluded that while bleach baths are effective in reducing the severity of AD, they do not appear to be more effective than water bath alone. Authors of a more recent study found that bleach baths did not normalize dysbiosis, “but that study did not compare outcomes to bathing without bleach,” Dr. Eichenfield noted.“My sense is there is some benefit to regular bathing, especially in children with moderate to severe AD, especially those with colonized or infected eczema.”

He advises clinicians to be aware of other “standard AD interventions” from around the world, including black tea wet dressings and green tea bath therapy.


 

Courtesy University of California, San Diego

Topical corticosteroids. These are “tried and true” for their anti-inflammatory properties and rapid response, relatively low cost, and large range of potency, he said. Potential problems include the burden of topical application and the potential for stinging/burning, atrophy, telangiectasias, adrenal axis suppression, and concerns about withdrawal phenomena. “Being a proponent of topical corticosteroids, but explaining reasonable and appropriate use can be challenging,” Dr. Eichenfield said. “Social media has influenced concerns about topical corticosteroids, with steroid addiction and withdrawal being concerns influencing discomfort with therapies.”

Make sure to measure outcomes. The suggested core outcome measure for recording clinical signs in AD clinical trials is the Eczema Area and Severity Index (EASI) score, he said. In clinical practice, Dr. Eichenfield favors body surface area (BSA) and the Validated Global Assessment scale (v-IGA) to measure signs of moderate to severe AD. “Documenting extent of disease makes a big difference in families understanding how severe their child’s disease is and how it is doing over time.” Alternatively, he recommends the Atopic Dermatitis Control Tool (ADCT) or the Recap of Atopic Eczema (RECAP) as tools assessing long-term disease control.

Familiarize yourself with nonsteroidal anti-inflammatory medications for care regimens. Options include topical calcineurin inhibitors (TCIs) such as tacrolimus and pimecrolimus; phosphodiesterase 4 (PDE-4) inhibitors such as crisaborole and roflumilast; the aryl-hydrocarbon receptor agonist tapinarof; and topical Janus kinase (JAK) inhibitors such as delgocitinib and ruxolitinib as well as others in development. “There is variable status around the world in terms of whether these nonsteroidal options are approved or not,” Dr. Eichenfield said. “Issues of use include cost, availability, side effects, and concerns about potential absorption. I think there’s an evolution in how much we rely on these instead of topical corticosteroids. They’re more commonly used in maintenance regimens rather than for remission induction.”

Dr. Eichenfield encouraged dermatologists to share information about and experiences with evolving treatment options for AD, “because when the studies are done, they are done as monotherapy. We must translate that into clinical practice and figure out how they fit in. Our exchange of information is critical.”

Dr. Eichenfield disclosed conflicts of interest from many pharmaceutical companies, including those with AD treatments.

SAN DIEGO — Whether you completed your dermatology residency training 20 years ago or 2 years ago, recent advances in treatments for atopic dermatitis (AD) have likely influenced your “go to” interventions when treating children with AD, according to Lawrence F. Eichenfield, MD.

“There have been many changes in the understanding of AD and recognition of the variable courses of the disease, and the associated allergic and nonallergic comorbidities,” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego in California, said at the Society for Pediatric Dermatology meeting, held the day before the annual meeting of the American Academy of Dermatology. “With our revolutionary systemic and evolving topical therapies, we are in a new day of pediatric management.”

LucaLorenzelli/Thinkstock

Drawing from 2023 American Academy of Dermatology guidelines of care on topical treatments of AD and his own clinical experience, he shared his perspective on “what’s tried and true” in care for patients with persistent eczema:

Both bathing and moisturizing leave skin moist. It’s well established that the use of moisturizers/emollients minimizes xerosis and the amount of prescription anti-inflammatory medications, but limited evidence exists to recommend a particular ingredient and formulation, said Dr. Eichenfield, also professor of dermatology and pediatrics at the University of California, San Diego. “Future studies may tell us whether specific moisturizers work better than others, and/or if early interventions may prevent AD, but that remains a big question mark,” he noted. In addition, applications may sometimes “mobilize” topical prescriptive residual absorption and activity.

As for baths, he said, “avoidance of bathing to avoid drying out skin is a practice without evidence basis. Bathing also may have many benefits in active eczema.”

Bleach baths may enhance skin barrier function, reduce itch, and improve eczema, but the practice remains controversial, he continued. Authors of a systematic review and meta-analysis concluded that while bleach baths are effective in reducing the severity of AD, they do not appear to be more effective than water bath alone. Authors of a more recent study found that bleach baths did not normalize dysbiosis, “but that study did not compare outcomes to bathing without bleach,” Dr. Eichenfield noted.“My sense is there is some benefit to regular bathing, especially in children with moderate to severe AD, especially those with colonized or infected eczema.”

He advises clinicians to be aware of other “standard AD interventions” from around the world, including black tea wet dressings and green tea bath therapy.


 

Courtesy University of California, San Diego

Topical corticosteroids. These are “tried and true” for their anti-inflammatory properties and rapid response, relatively low cost, and large range of potency, he said. Potential problems include the burden of topical application and the potential for stinging/burning, atrophy, telangiectasias, adrenal axis suppression, and concerns about withdrawal phenomena. “Being a proponent of topical corticosteroids, but explaining reasonable and appropriate use can be challenging,” Dr. Eichenfield said. “Social media has influenced concerns about topical corticosteroids, with steroid addiction and withdrawal being concerns influencing discomfort with therapies.”

Make sure to measure outcomes. The suggested core outcome measure for recording clinical signs in AD clinical trials is the Eczema Area and Severity Index (EASI) score, he said. In clinical practice, Dr. Eichenfield favors body surface area (BSA) and the Validated Global Assessment scale (v-IGA) to measure signs of moderate to severe AD. “Documenting extent of disease makes a big difference in families understanding how severe their child’s disease is and how it is doing over time.” Alternatively, he recommends the Atopic Dermatitis Control Tool (ADCT) or the Recap of Atopic Eczema (RECAP) as tools assessing long-term disease control.

Familiarize yourself with nonsteroidal anti-inflammatory medications for care regimens. Options include topical calcineurin inhibitors (TCIs) such as tacrolimus and pimecrolimus; phosphodiesterase 4 (PDE-4) inhibitors such as crisaborole and roflumilast; the aryl-hydrocarbon receptor agonist tapinarof; and topical Janus kinase (JAK) inhibitors such as delgocitinib and ruxolitinib as well as others in development. “There is variable status around the world in terms of whether these nonsteroidal options are approved or not,” Dr. Eichenfield said. “Issues of use include cost, availability, side effects, and concerns about potential absorption. I think there’s an evolution in how much we rely on these instead of topical corticosteroids. They’re more commonly used in maintenance regimens rather than for remission induction.”

Dr. Eichenfield encouraged dermatologists to share information about and experiences with evolving treatment options for AD, “because when the studies are done, they are done as monotherapy. We must translate that into clinical practice and figure out how they fit in. Our exchange of information is critical.”

Dr. Eichenfield disclosed conflicts of interest from many pharmaceutical companies, including those with AD treatments.

SAN DIEGO — Compared with the use of topical minoxidil for hair loss, the used of low-dose oral minoxidil (LDOM) can be considered when topical minoxidil is more expensive or logistically challenging, has plateaued in efficacy, leaves unwanted product residue, causes skin irritation, or exacerbates the inflammatory process.

Those are among the key recommendations that resulted from a modified eDelphi consensus of experts who convened to develop guidelines for LDOM prescribing and monitoring.

“Topical minoxidil is safe, effective, over-the-counter, and FDA-approved to treat the most common form of hair loss, androgenetic alopecia,” one of the study authors, Jennifer Fu, MD, a dermatologist who directs the Hair Disorders Clinic at the University of California, San Francisco, told this news organization following the annual meeting of the American Academy of Dermatology. The results of the expert consensus were presented during a poster session at the meeting. “It is often used off label for other types of hair loss, yet clinicians who treat hair loss know that patient compliance with topical minoxidil can be poor for a variety of reasons,” she said. “Patients report that it can be difficult to apply and complicate hair styling. For many patients, topical minoxidil can be drying or cause irritant or allergic contact reactions.”

Dr. Fu

LDOM has become a popular alternative for patients for whom topical minoxidil is logistically challenging, irritating, or ineffective, she continued. Although oral minoxidil is no longer a first-line antihypertensive agent given the risk of cardiovascular adverse effects at higher antihypertensive dosing (10-40 mg daily), a growing number of small studies have documented the use of LDOM at doses ranging from 0.25 mg to 5 mg daily as a safe, effective option for various types of hair loss.

“Given the current absence of larger trials on this topic, our research group identified a need for expert-based guidelines for prescribing and monitoring LDOM use in hair loss patients,” Dr. Fu said. “Our goal was to provide clinicians who treat hair loss patients a road map for using LDOM effectively, maximizing hair growth, and minimizing potential cardiovascular adverse effects.”


 

Arriving at a Consensus

The process involved 43 hair loss specialists from 12 countries with an average of 6.29 years of experience with LDOM for hair loss, who participated in a multi-round modified Delphi process. They considered questions that addressed LDOM safety, efficacy, dosing, and monitoring for hair loss, and consensus was reached if at least 70% of participants indicated “agree” or “strongly agree” on a five-point Likert scale. Round 1 consisted of 180 open-ended, multiple-choice, or Likert-scale questions, while round 2 involved 121 Likert-scale questions, round 3 consisted of 16 Likert-scale questions, and round 4 included 11 Likert-scale questions. In all, 94 items achieved Likert-scale consensus.

Specifically, experts on the panel found a direct benefit of LDOM for androgenetic alopecia, age-related patterned thinning, alopecia areata, telogen effluvium, traction alopecia, persistent chemotherapy-induced alopecia, and endocrine therapy-induced alopecia. They found a supportive benefit of LDOM for lichen planopilaris, frontal fibrosing alopecia, central centrifugal alopecia, and fibrosing alopecia in a patterned distribution.

“LDOM can be considered when topical minoxidil is more expensive, logistically challenging, has plateaued in efficacy, results in undesirable product residue/skin irritation,” or exacerbates inflammatory processes (ie eczema, psoriasis), they added.

Contraindications to LDOM listed in the consensus recommendations include hypersensitivity to minoxidil, significant drug-drug interactions with LDOM, a history of pericardial effusion/tamponade, pericarditis, heart failure, pulmonary hypertension associated with mitral stenosis, pheochromocytoma, and pregnancy/breastfeeding. Cited precautions of LDOM use include a history of tachycardia or arrhythmia, hypotension, renal impairment, and being on dialysis.

Dr. Fu and colleagues noted that the earliest time point at which LDOM should be expected to demonstrate efficacy is 3-6 months. “Baseline testing is not routine but may be considered in case of identified precautions,” they wrote. They also noted that LDOM can possibly be co-administered with beta-blockers with a specialty consultation, and with spironolactone in biologic female or transgender female patients with hirsutism, acne, polycystic ovary syndrome (PCOS), and with lower extremity and facial edema.

According to the consensus statement, the most frequently prescribed LDOM dosing regimen in adult females aged 18 years and older includes a starting dose of 1.25 mg daily, with a dosing range between 0.625 mg and 5 mg daily. For adult males, the most frequently prescribed dosing regimen is a starting dose of 2.5 daily, with a dosing range between 1.25 mg and 5 mg daily. The most frequently prescribed LDOM dosing regimen in adolescent females aged 12-17 years is a starting dose of 0.625 mg daily, with a dosing range of 0.625 to 2.5 mg daily. For adolescent males, the recommended regimen is a starting dose of 1.25 mg daily, with a dosing range of 1.25 mg to 5 mg daily.

“We hope that this consensus statement will guide our colleagues who would like to use LDOM to treat hair loss in their adult and adolescent patients,” Dr. Fu told this news organization. “These recommendations may be used to inform clinical practice until additional evidence-based data becomes available.”

She acknowledged certain limitations of the effort, including the fact that the expert panel was underrepresented in treating hair loss in pediatric patients, “and therefore failed to reach consensus on LDOM pediatric use and dosing,” she said. “We encourage our pediatric dermatology colleagues to further research LDOM in pediatric patients.”

In an interview, Shari Lipner, MD, PhD, associate professor of clinical dermatology, Weill Cornell Medicine, New York, who was asked to comment, but was not involved with the work, characterized the consensus as a “helpful, concise reference guide for dermatologists.”

Dr. Lipner

The advantages of the study are the standardized methods used, “and the experience of the panel,” she said. “Study limitations include the response rate, which was less than 60%, and the risk of potential side effects are not stratified by age, sex, or comorbidities,” she added.

Dr. Fu disclosed that she is a consultant to Pfizer. Dr. Lipner reported having no relevant disclosures.

SAN DIEGO — Compared with the use of topical minoxidil for hair loss, the used of low-dose oral minoxidil (LDOM) can be considered when topical minoxidil is more expensive or logistically challenging, has plateaued in efficacy, leaves unwanted product residue, causes skin irritation, or exacerbates the inflammatory process.

Those are among the key recommendations that resulted from a modified eDelphi consensus of experts who convened to develop guidelines for LDOM prescribing and monitoring.

“Topical minoxidil is safe, effective, over-the-counter, and FDA-approved to treat the most common form of hair loss, androgenetic alopecia,” one of the study authors, Jennifer Fu, MD, a dermatologist who directs the Hair Disorders Clinic at the University of California, San Francisco, told this news organization following the annual meeting of the American Academy of Dermatology. The results of the expert consensus were presented during a poster session at the meeting. “It is often used off label for other types of hair loss, yet clinicians who treat hair loss know that patient compliance with topical minoxidil can be poor for a variety of reasons,” she said. “Patients report that it can be difficult to apply and complicate hair styling. For many patients, topical minoxidil can be drying or cause irritant or allergic contact reactions.”

Dr. Fu

LDOM has become a popular alternative for patients for whom topical minoxidil is logistically challenging, irritating, or ineffective, she continued. Although oral minoxidil is no longer a first-line antihypertensive agent given the risk of cardiovascular adverse effects at higher antihypertensive dosing (10-40 mg daily), a growing number of small studies have documented the use of LDOM at doses ranging from 0.25 mg to 5 mg daily as a safe, effective option for various types of hair loss.

“Given the current absence of larger trials on this topic, our research group identified a need for expert-based guidelines for prescribing and monitoring LDOM use in hair loss patients,” Dr. Fu said. “Our goal was to provide clinicians who treat hair loss patients a road map for using LDOM effectively, maximizing hair growth, and minimizing potential cardiovascular adverse effects.”


 

Arriving at a Consensus

The process involved 43 hair loss specialists from 12 countries with an average of 6.29 years of experience with LDOM for hair loss, who participated in a multi-round modified Delphi process. They considered questions that addressed LDOM safety, efficacy, dosing, and monitoring for hair loss, and consensus was reached if at least 70% of participants indicated “agree” or “strongly agree” on a five-point Likert scale. Round 1 consisted of 180 open-ended, multiple-choice, or Likert-scale questions, while round 2 involved 121 Likert-scale questions, round 3 consisted of 16 Likert-scale questions, and round 4 included 11 Likert-scale questions. In all, 94 items achieved Likert-scale consensus.

Specifically, experts on the panel found a direct benefit of LDOM for androgenetic alopecia, age-related patterned thinning, alopecia areata, telogen effluvium, traction alopecia, persistent chemotherapy-induced alopecia, and endocrine therapy-induced alopecia. They found a supportive benefit of LDOM for lichen planopilaris, frontal fibrosing alopecia, central centrifugal alopecia, and fibrosing alopecia in a patterned distribution.

“LDOM can be considered when topical minoxidil is more expensive, logistically challenging, has plateaued in efficacy, results in undesirable product residue/skin irritation,” or exacerbates inflammatory processes (ie eczema, psoriasis), they added.

Contraindications to LDOM listed in the consensus recommendations include hypersensitivity to minoxidil, significant drug-drug interactions with LDOM, a history of pericardial effusion/tamponade, pericarditis, heart failure, pulmonary hypertension associated with mitral stenosis, pheochromocytoma, and pregnancy/breastfeeding. Cited precautions of LDOM use include a history of tachycardia or arrhythmia, hypotension, renal impairment, and being on dialysis.

Dr. Fu and colleagues noted that the earliest time point at which LDOM should be expected to demonstrate efficacy is 3-6 months. “Baseline testing is not routine but may be considered in case of identified precautions,” they wrote. They also noted that LDOM can possibly be co-administered with beta-blockers with a specialty consultation, and with spironolactone in biologic female or transgender female patients with hirsutism, acne, polycystic ovary syndrome (PCOS), and with lower extremity and facial edema.

According to the consensus statement, the most frequently prescribed LDOM dosing regimen in adult females aged 18 years and older includes a starting dose of 1.25 mg daily, with a dosing range between 0.625 mg and 5 mg daily. For adult males, the most frequently prescribed dosing regimen is a starting dose of 2.5 daily, with a dosing range between 1.25 mg and 5 mg daily. The most frequently prescribed LDOM dosing regimen in adolescent females aged 12-17 years is a starting dose of 0.625 mg daily, with a dosing range of 0.625 to 2.5 mg daily. For adolescent males, the recommended regimen is a starting dose of 1.25 mg daily, with a dosing range of 1.25 mg to 5 mg daily.

“We hope that this consensus statement will guide our colleagues who would like to use LDOM to treat hair loss in their adult and adolescent patients,” Dr. Fu told this news organization. “These recommendations may be used to inform clinical practice until additional evidence-based data becomes available.”

She acknowledged certain limitations of the effort, including the fact that the expert panel was underrepresented in treating hair loss in pediatric patients, “and therefore failed to reach consensus on LDOM pediatric use and dosing,” she said. “We encourage our pediatric dermatology colleagues to further research LDOM in pediatric patients.”

In an interview, Shari Lipner, MD, PhD, associate professor of clinical dermatology, Weill Cornell Medicine, New York, who was asked to comment, but was not involved with the work, characterized the consensus as a “helpful, concise reference guide for dermatologists.”

Dr. Lipner

The advantages of the study are the standardized methods used, “and the experience of the panel,” she said. “Study limitations include the response rate, which was less than 60%, and the risk of potential side effects are not stratified by age, sex, or comorbidities,” she added.

Dr. Fu disclosed that she is a consultant to Pfizer. Dr. Lipner reported having no relevant disclosures.

SAN DIEGO — Compared with the use of topical minoxidil for hair loss, the used of low-dose oral minoxidil (LDOM) can be considered when topical minoxidil is more expensive or logistically challenging, has plateaued in efficacy, leaves unwanted product residue, causes skin irritation, or exacerbates the inflammatory process.

Those are among the key recommendations that resulted from a modified eDelphi consensus of experts who convened to develop guidelines for LDOM prescribing and monitoring.

“Topical minoxidil is safe, effective, over-the-counter, and FDA-approved to treat the most common form of hair loss, androgenetic alopecia,” one of the study authors, Jennifer Fu, MD, a dermatologist who directs the Hair Disorders Clinic at the University of California, San Francisco, told this news organization following the annual meeting of the American Academy of Dermatology. The results of the expert consensus were presented during a poster session at the meeting. “It is often used off label for other types of hair loss, yet clinicians who treat hair loss know that patient compliance with topical minoxidil can be poor for a variety of reasons,” she said. “Patients report that it can be difficult to apply and complicate hair styling. For many patients, topical minoxidil can be drying or cause irritant or allergic contact reactions.”

Dr. Fu

LDOM has become a popular alternative for patients for whom topical minoxidil is logistically challenging, irritating, or ineffective, she continued. Although oral minoxidil is no longer a first-line antihypertensive agent given the risk of cardiovascular adverse effects at higher antihypertensive dosing (10-40 mg daily), a growing number of small studies have documented the use of LDOM at doses ranging from 0.25 mg to 5 mg daily as a safe, effective option for various types of hair loss.

“Given the current absence of larger trials on this topic, our research group identified a need for expert-based guidelines for prescribing and monitoring LDOM use in hair loss patients,” Dr. Fu said. “Our goal was to provide clinicians who treat hair loss patients a road map for using LDOM effectively, maximizing hair growth, and minimizing potential cardiovascular adverse effects.”


 

Arriving at a Consensus

The process involved 43 hair loss specialists from 12 countries with an average of 6.29 years of experience with LDOM for hair loss, who participated in a multi-round modified Delphi process. They considered questions that addressed LDOM safety, efficacy, dosing, and monitoring for hair loss, and consensus was reached if at least 70% of participants indicated “agree” or “strongly agree” on a five-point Likert scale. Round 1 consisted of 180 open-ended, multiple-choice, or Likert-scale questions, while round 2 involved 121 Likert-scale questions, round 3 consisted of 16 Likert-scale questions, and round 4 included 11 Likert-scale questions. In all, 94 items achieved Likert-scale consensus.

Specifically, experts on the panel found a direct benefit of LDOM for androgenetic alopecia, age-related patterned thinning, alopecia areata, telogen effluvium, traction alopecia, persistent chemotherapy-induced alopecia, and endocrine therapy-induced alopecia. They found a supportive benefit of LDOM for lichen planopilaris, frontal fibrosing alopecia, central centrifugal alopecia, and fibrosing alopecia in a patterned distribution.

“LDOM can be considered when topical minoxidil is more expensive, logistically challenging, has plateaued in efficacy, results in undesirable product residue/skin irritation,” or exacerbates inflammatory processes (ie eczema, psoriasis), they added.

Contraindications to LDOM listed in the consensus recommendations include hypersensitivity to minoxidil, significant drug-drug interactions with LDOM, a history of pericardial effusion/tamponade, pericarditis, heart failure, pulmonary hypertension associated with mitral stenosis, pheochromocytoma, and pregnancy/breastfeeding. Cited precautions of LDOM use include a history of tachycardia or arrhythmia, hypotension, renal impairment, and being on dialysis.

Dr. Fu and colleagues noted that the earliest time point at which LDOM should be expected to demonstrate efficacy is 3-6 months. “Baseline testing is not routine but may be considered in case of identified precautions,” they wrote. They also noted that LDOM can possibly be co-administered with beta-blockers with a specialty consultation, and with spironolactone in biologic female or transgender female patients with hirsutism, acne, polycystic ovary syndrome (PCOS), and with lower extremity and facial edema.

According to the consensus statement, the most frequently prescribed LDOM dosing regimen in adult females aged 18 years and older includes a starting dose of 1.25 mg daily, with a dosing range between 0.625 mg and 5 mg daily. For adult males, the most frequently prescribed dosing regimen is a starting dose of 2.5 daily, with a dosing range between 1.25 mg and 5 mg daily. The most frequently prescribed LDOM dosing regimen in adolescent females aged 12-17 years is a starting dose of 0.625 mg daily, with a dosing range of 0.625 to 2.5 mg daily. For adolescent males, the recommended regimen is a starting dose of 1.25 mg daily, with a dosing range of 1.25 mg to 5 mg daily.

“We hope that this consensus statement will guide our colleagues who would like to use LDOM to treat hair loss in their adult and adolescent patients,” Dr. Fu told this news organization. “These recommendations may be used to inform clinical practice until additional evidence-based data becomes available.”

She acknowledged certain limitations of the effort, including the fact that the expert panel was underrepresented in treating hair loss in pediatric patients, “and therefore failed to reach consensus on LDOM pediatric use and dosing,” she said. “We encourage our pediatric dermatology colleagues to further research LDOM in pediatric patients.”

In an interview, Shari Lipner, MD, PhD, associate professor of clinical dermatology, Weill Cornell Medicine, New York, who was asked to comment, but was not involved with the work, characterized the consensus as a “helpful, concise reference guide for dermatologists.”

Dr. Lipner

The advantages of the study are the standardized methods used, “and the experience of the panel,” she said. “Study limitations include the response rate, which was less than 60%, and the risk of potential side effects are not stratified by age, sex, or comorbidities,” she added.

Dr. Fu disclosed that she is a consultant to Pfizer. Dr. Lipner reported having no relevant disclosures.

TOPLINE:

Infants with port-wine birthmarks (PWB) achieved near-total or total clearance with weekly pulsed dye laser (PDL) treatments in a case-series of 10 infants.

METHODOLOGY:

• Early intervention of PWB in infants can significantly improve outcomes, and some studies suggest shorter intervals between laser treatments may be more effective. While laser treatment with PDL is the gold standard, the optimal treatment interval has not been determined.
• Researchers evaluated the records of 10 infants with PWB who received weekly PDL treatments from 2022 to 2023 at a single center. Treatment was initiated when the infants were 6 months old or younger, with the median age at the first treatment being 4 weeks. Of the 10 infants, eight had Fitzpatrick skin types I-III and two had skin type IV.
• Two dermatologists assessed photographs taken before and after laser treatment, and the primary outcome was the percentage improvement of PWB.

TAKEAWAY:

• Of the 10 patients, six achieved near-total (76%-95%) clearance, and one achieved total (96%-100%) clearance of PWB at a mean of 2 months after the first treatment.
• Marked improvement (51%-75%) in PWB was observed in the remaining three patients, who achieved near-total clearance with additional treatments.
• The median duration of treatment was 2 months (range, 0.2-5.1), and a median of eight treatments (range, 2-20) were needed to achieve near total or total clearance.
• No adverse events were reported, including pigmentary changes, scarring, burns, erosions, or infections.

IN PRACTICE:

The outcomes in the case series, the authors concluded, “are compelling and warrant attention and further investigation into the possibility that this novel and decreased treatment interval of 1 week ... is associated with potential improvement in outcomes and shorter overall treatment duration.”

SOURCE:

This study was led by Shirin Bajaj, MD, of the Laser & Skin Surgery Center of New York, where the infants were treated, and was published online on April 17, 2024, in JAMA Dermatology.

LIMITATIONS:

A small sample size and the lack of a comparison arm limited the ability to draw any conclusions or make treatment recommendations based on the results.

DISCLOSURES:

The authors disclosed no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Infants with port-wine birthmarks (PWB) achieved near-total or total clearance with weekly pulsed dye laser (PDL) treatments in a case-series of 10 infants.

METHODOLOGY:

• Early intervention of PWB in infants can significantly improve outcomes, and some studies suggest shorter intervals between laser treatments may be more effective. While laser treatment with PDL is the gold standard, the optimal treatment interval has not been determined.
• Researchers evaluated the records of 10 infants with PWB who received weekly PDL treatments from 2022 to 2023 at a single center. Treatment was initiated when the infants were 6 months old or younger, with the median age at the first treatment being 4 weeks. Of the 10 infants, eight had Fitzpatrick skin types I-III and two had skin type IV.
• Two dermatologists assessed photographs taken before and after laser treatment, and the primary outcome was the percentage improvement of PWB.

TAKEAWAY:

• Of the 10 patients, six achieved near-total (76%-95%) clearance, and one achieved total (96%-100%) clearance of PWB at a mean of 2 months after the first treatment.
• Marked improvement (51%-75%) in PWB was observed in the remaining three patients, who achieved near-total clearance with additional treatments.
• The median duration of treatment was 2 months (range, 0.2-5.1), and a median of eight treatments (range, 2-20) were needed to achieve near total or total clearance.
• No adverse events were reported, including pigmentary changes, scarring, burns, erosions, or infections.

IN PRACTICE:

The outcomes in the case series, the authors concluded, “are compelling and warrant attention and further investigation into the possibility that this novel and decreased treatment interval of 1 week ... is associated with potential improvement in outcomes and shorter overall treatment duration.”

SOURCE:

This study was led by Shirin Bajaj, MD, of the Laser & Skin Surgery Center of New York, where the infants were treated, and was published online on April 17, 2024, in JAMA Dermatology.

LIMITATIONS:

A small sample size and the lack of a comparison arm limited the ability to draw any conclusions or make treatment recommendations based on the results.

DISCLOSURES:

The authors disclosed no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Infants with port-wine birthmarks (PWB) achieved near-total or total clearance with weekly pulsed dye laser (PDL) treatments in a case-series of 10 infants.

METHODOLOGY:

• Early intervention of PWB in infants can significantly improve outcomes, and some studies suggest shorter intervals between laser treatments may be more effective. While laser treatment with PDL is the gold standard, the optimal treatment interval has not been determined.
• Researchers evaluated the records of 10 infants with PWB who received weekly PDL treatments from 2022 to 2023 at a single center. Treatment was initiated when the infants were 6 months old or younger, with the median age at the first treatment being 4 weeks. Of the 10 infants, eight had Fitzpatrick skin types I-III and two had skin type IV.
• Two dermatologists assessed photographs taken before and after laser treatment, and the primary outcome was the percentage improvement of PWB.

TAKEAWAY:

• Of the 10 patients, six achieved near-total (76%-95%) clearance, and one achieved total (96%-100%) clearance of PWB at a mean of 2 months after the first treatment.
• Marked improvement (51%-75%) in PWB was observed in the remaining three patients, who achieved near-total clearance with additional treatments.
• The median duration of treatment was 2 months (range, 0.2-5.1), and a median of eight treatments (range, 2-20) were needed to achieve near total or total clearance.
• No adverse events were reported, including pigmentary changes, scarring, burns, erosions, or infections.

IN PRACTICE:

The outcomes in the case series, the authors concluded, “are compelling and warrant attention and further investigation into the possibility that this novel and decreased treatment interval of 1 week ... is associated with potential improvement in outcomes and shorter overall treatment duration.”

SOURCE:

This study was led by Shirin Bajaj, MD, of the Laser & Skin Surgery Center of New York, where the infants were treated, and was published online on April 17, 2024, in JAMA Dermatology.

LIMITATIONS:

A small sample size and the lack of a comparison arm limited the ability to draw any conclusions or make treatment recommendations based on the results.

DISCLOSURES:

The authors disclosed no conflicts of interest.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.

This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals. 

Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release. 

“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release. 

The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis. 

The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.

Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.

This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals. 

Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release. 

“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release. 

The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis. 

The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.

Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.

This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals. 

Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release. 

“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release. 

The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis. 

The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.

Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson. 

A version of this article appeared on Medscape.com.

BALTIMORE — Patients who have complications after dermatologic cosmetic procedures are prone to high rates of a host of mental health issues, ranging from anxiety disorder and depression to body dysmorphic disorder (BDD) and posttraumatic stress disorder (PTSD), according to a survey-based study of patients with dermatology-related complications. 

The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.

Taryn Murray, MD

“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
 

Rise in Mental Health Issues

The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results. 

Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.

“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”

Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”

The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).

The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).

Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.

“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
 

Take-Home Lesson

The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”

She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”

She said she hopes her findings lead to more research in the future.

Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”

She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.

The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”

Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.

A version of this article appeared on Medscape.com.

BALTIMORE — Patients who have complications after dermatologic cosmetic procedures are prone to high rates of a host of mental health issues, ranging from anxiety disorder and depression to body dysmorphic disorder (BDD) and posttraumatic stress disorder (PTSD), according to a survey-based study of patients with dermatology-related complications. 

The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.

Taryn Murray, MD

“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
 

Rise in Mental Health Issues

The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results. 

Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.

“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”

Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”

The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).

The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).

Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.

“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
 

Take-Home Lesson

The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”

She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”

She said she hopes her findings lead to more research in the future.

Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”

She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.

The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”

Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.

A version of this article appeared on Medscape.com.

BALTIMORE — Patients who have complications after dermatologic cosmetic procedures are prone to high rates of a host of mental health issues, ranging from anxiety disorder and depression to body dysmorphic disorder (BDD) and posttraumatic stress disorder (PTSD), according to a survey-based study of patients with dermatology-related complications. 

The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.

Taryn Murray, MD

“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
 

Rise in Mental Health Issues

The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results. 

Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.

“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”

Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”

The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).

The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).

Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.

“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
 

Take-Home Lesson

The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”

She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”

She said she hopes her findings lead to more research in the future.

Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”

She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.

The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”

Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.

A version of this article appeared on Medscape.com.

Recent cases of botulism-like illness following neurotoxin injections in nonmedical settings have prompted the American Society for Dermatologic Surgery Association (ASDSA) to call on states to increase oversight of medical care in all settings, including medical spas.

In a press release issued on April 12, the ASDSA referenced investigations in Illinois and Tennessee in which suspected counterfeit neurotoxins were associated with individuals’ symptoms resembling botulism, including several that required hospitalization. These cases “emphasize the patient safety risks associated with receiving medical procedures in unlicensed, unapproved settings without proper oversight of medical care,” the release adds.

The cases also “highlight the need for increased public protection measures, like the recommendations in the ASDSA’s “Medical Spa Safety Act” to ensure patients’ safety,” according to the press release, which notes the increasing demand for facial fillers and neuromodulators in the United States.

Enforcement is needed to ensure that all patients receive US Food and Drug Administration (FDA)-approved products “and not counterfeit products or unsafe treatments,” ASDSA president Seth L. Matarasso, MD, who practices dermatology in San Francisco, said in the press release. “Lack of regulation and enforcement has enabled many to offer medical procedures for cosmetic purposes outside of their training and expertise,” he said.

Key Takeaways

All clinicians need to understand that aesthetic procedures are medical procedures and require a level of due diligence in patient evaluation and care before, during, and after the procedure, Pooja Sodha, MD, director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington, said in an interview.

Dr. Sodha

“FDA-approved medications should only be offered, and these should be obtained through well-defined sources to ensure their safety and purity,” she said.

However, some challenges to the enforcement of safety in medical spa settings persist, Dr. Sodha told this news organization. “To my knowledge, state and federal policies providing clear and up-to-date safety and legal guidelines for aesthetic procedures performed at medical spas by registered nurses, nurse practitioners, physician assistants, and physicians are limited, and in our current medical care structure, national oversight is challenging,” she said.

A pretreatment checklist assessment, she suggested, could be helpful “to ensure patient safety and help to standardize clinical practice in nonmedical settings.”

Other challenges include a lack of clear guidelines for aesthetic providers regarding initial assessment examinations, postprocedure follow-up, and evaluation for any future medical treatment, as well as “continued ambiguity on the exact meaning of physician oversight for those sites that delegate aesthetic services and appropriate and clear guidelines on what procedures require a licensed provider to perform versus oversee the treatment,” she said.
 

Additional Guidance, Actions Needed

As for additional guidance or actions, “we may be migrating towards a system that designates and assigns clearer licenses and authorizations to perform these services and care for patients,” said Dr. Sodha. A licensing process would entail academic understanding of anatomy, pharmacology, and tissue interactions, as well as practical hands-on training that emphasizes the importance of the preprocedure consultation and postprocedure follow-up and care, she said. “Experience in caring for the unintended outcomes is vital to delivering the best care we can,” she added.

D. Sodha had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

Recent cases of botulism-like illness following neurotoxin injections in nonmedical settings have prompted the American Society for Dermatologic Surgery Association (ASDSA) to call on states to increase oversight of medical care in all settings, including medical spas.

In a press release issued on April 12, the ASDSA referenced investigations in Illinois and Tennessee in which suspected counterfeit neurotoxins were associated with individuals’ symptoms resembling botulism, including several that required hospitalization. These cases “emphasize the patient safety risks associated with receiving medical procedures in unlicensed, unapproved settings without proper oversight of medical care,” the release adds.

The cases also “highlight the need for increased public protection measures, like the recommendations in the ASDSA’s “Medical Spa Safety Act” to ensure patients’ safety,” according to the press release, which notes the increasing demand for facial fillers and neuromodulators in the United States.

Enforcement is needed to ensure that all patients receive US Food and Drug Administration (FDA)-approved products “and not counterfeit products or unsafe treatments,” ASDSA president Seth L. Matarasso, MD, who practices dermatology in San Francisco, said in the press release. “Lack of regulation and enforcement has enabled many to offer medical procedures for cosmetic purposes outside of their training and expertise,” he said.

Key Takeaways

All clinicians need to understand that aesthetic procedures are medical procedures and require a level of due diligence in patient evaluation and care before, during, and after the procedure, Pooja Sodha, MD, director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington, said in an interview.

Dr. Sodha

“FDA-approved medications should only be offered, and these should be obtained through well-defined sources to ensure their safety and purity,” she said.

However, some challenges to the enforcement of safety in medical spa settings persist, Dr. Sodha told this news organization. “To my knowledge, state and federal policies providing clear and up-to-date safety and legal guidelines for aesthetic procedures performed at medical spas by registered nurses, nurse practitioners, physician assistants, and physicians are limited, and in our current medical care structure, national oversight is challenging,” she said.

A pretreatment checklist assessment, she suggested, could be helpful “to ensure patient safety and help to standardize clinical practice in nonmedical settings.”

Other challenges include a lack of clear guidelines for aesthetic providers regarding initial assessment examinations, postprocedure follow-up, and evaluation for any future medical treatment, as well as “continued ambiguity on the exact meaning of physician oversight for those sites that delegate aesthetic services and appropriate and clear guidelines on what procedures require a licensed provider to perform versus oversee the treatment,” she said.
 

Additional Guidance, Actions Needed

As for additional guidance or actions, “we may be migrating towards a system that designates and assigns clearer licenses and authorizations to perform these services and care for patients,” said Dr. Sodha. A licensing process would entail academic understanding of anatomy, pharmacology, and tissue interactions, as well as practical hands-on training that emphasizes the importance of the preprocedure consultation and postprocedure follow-up and care, she said. “Experience in caring for the unintended outcomes is vital to delivering the best care we can,” she added.

D. Sodha had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

Recent cases of botulism-like illness following neurotoxin injections in nonmedical settings have prompted the American Society for Dermatologic Surgery Association (ASDSA) to call on states to increase oversight of medical care in all settings, including medical spas.

In a press release issued on April 12, the ASDSA referenced investigations in Illinois and Tennessee in which suspected counterfeit neurotoxins were associated with individuals’ symptoms resembling botulism, including several that required hospitalization. These cases “emphasize the patient safety risks associated with receiving medical procedures in unlicensed, unapproved settings without proper oversight of medical care,” the release adds.

The cases also “highlight the need for increased public protection measures, like the recommendations in the ASDSA’s “Medical Spa Safety Act” to ensure patients’ safety,” according to the press release, which notes the increasing demand for facial fillers and neuromodulators in the United States.

Enforcement is needed to ensure that all patients receive US Food and Drug Administration (FDA)-approved products “and not counterfeit products or unsafe treatments,” ASDSA president Seth L. Matarasso, MD, who practices dermatology in San Francisco, said in the press release. “Lack of regulation and enforcement has enabled many to offer medical procedures for cosmetic purposes outside of their training and expertise,” he said.

Key Takeaways

All clinicians need to understand that aesthetic procedures are medical procedures and require a level of due diligence in patient evaluation and care before, during, and after the procedure, Pooja Sodha, MD, director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington, said in an interview.

Dr. Sodha

“FDA-approved medications should only be offered, and these should be obtained through well-defined sources to ensure their safety and purity,” she said.

However, some challenges to the enforcement of safety in medical spa settings persist, Dr. Sodha told this news organization. “To my knowledge, state and federal policies providing clear and up-to-date safety and legal guidelines for aesthetic procedures performed at medical spas by registered nurses, nurse practitioners, physician assistants, and physicians are limited, and in our current medical care structure, national oversight is challenging,” she said.

A pretreatment checklist assessment, she suggested, could be helpful “to ensure patient safety and help to standardize clinical practice in nonmedical settings.”

Other challenges include a lack of clear guidelines for aesthetic providers regarding initial assessment examinations, postprocedure follow-up, and evaluation for any future medical treatment, as well as “continued ambiguity on the exact meaning of physician oversight for those sites that delegate aesthetic services and appropriate and clear guidelines on what procedures require a licensed provider to perform versus oversee the treatment,” she said.
 

Additional Guidance, Actions Needed

As for additional guidance or actions, “we may be migrating towards a system that designates and assigns clearer licenses and authorizations to perform these services and care for patients,” said Dr. Sodha. A licensing process would entail academic understanding of anatomy, pharmacology, and tissue interactions, as well as practical hands-on training that emphasizes the importance of the preprocedure consultation and postprocedure follow-up and care, she said. “Experience in caring for the unintended outcomes is vital to delivering the best care we can,” she added.

D. Sodha had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

At least 19 people from nine states have reported serious reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in non-healthcare settings, such as homes and spas, according to an announcement of an investigation into these reports from the Centers for Disease Control and Prevention posted online April 15.

Reactions have included blurry vision, double vision, drooping eyelids, difficult swallowing or breathing, and other symptoms of botulism.

Of the 19 individuals — all of whom identified as female and had a mean age of 39 years — 9 (60%) were hospitalized and 4 (21%) were treated with botulism antitoxin because of concerns that the botulinum toxin could have spread beyond the injection site. Also, five were tested for botulism and their results were negative.

The CDC, several state and local health departments, and the US Food and Drug Administration (FDA) are investigating these reports, according to the announcement.

States reporting these cases include Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington. According to the CDC summary, some of the individuals “received injections with counterfeit products or products with unverified sources. Investigation into the sources of these products is ongoing.” All but one report involved receiving botulinum toxin injections for cosmetic purposes.

Recent cases of botulism-like illnesses possibly related to counterfeit botulinum toxin reported in Illinois and Tennessee, prompted the American Society for Dermatologic Surgery Association (ASDSA) to call on states to increase oversight of medical care in all settings, including medical spas, the ASDSA announced on April 12.

The CDC summary advises clinicians to consider the possibility of adverse effects from botulinum toxin injection, including for cosmetic reasons, when patients present with signs and symptoms consistent with botulism near the injection site. Symptoms of botulism include blurry or double vision, drooping eyelids, difficulty swallowing, difficulty breathing, and muscle weakness.

For people who are considering botulinum toxin for cosmetic or medical reasons, recommendations from the CDC include asking the provider and setting, such as a clinic or spa, if they are licensed and trained to provide these injections, and to ask if the product is approved by the FDA and from a reliable source, and, “if in doubt, don’t get the injection.”

This ‘Should Never Happen’

“The report of people getting botulism from botulinum toxin injections is frightening, and should never happen,” Lawrence J. Green, MD, clinical professor of dermatology, George Washington University, Washington, told this news organization.

Dr. Green

These reports show “how important it is to receive botulinum toxin injections only in a medical office, and from or under the direction of a qualified, trained, and licensed individual, like a board certified dermatologist,” added Dr. Green, who practices in Rockville, Maryland. “Other types of practitioners may not adhere to the same standards of professionalism, especially not always putting patient safety first.”

Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
 

For cases of suspected systemic botulism, the CDC recommends calling the local or state health department for consultation and antitoxin release (as well as information on reporting adverse events). Alternatively, the 24/7 phone number for the CDC clinical botulism service is 770-488-7100.

At least 19 people from nine states have reported serious reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in non-healthcare settings, such as homes and spas, according to an announcement of an investigation into these reports from the Centers for Disease Control and Prevention posted online April 15.

Reactions have included blurry vision, double vision, drooping eyelids, difficult swallowing or breathing, and other symptoms of botulism.

Of the 19 individuals — all of whom identified as female and had a mean age of 39 years — 9 (60%) were hospitalized and 4 (21%) were treated with botulism antitoxin because of concerns that the botulinum toxin could have spread beyond the injection site. Also, five were tested for botulism and their results were negative.

The CDC, several state and local health departments, and the US Food and Drug Administration (FDA) are investigating these reports, according to the announcement.

States reporting these cases include Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington. According to the CDC summary, some of the individuals “received injections with counterfeit products or products with unverified sources. Investigation into the sources of these products is ongoing.” All but one report involved receiving botulinum toxin injections for cosmetic purposes.

Recent cases of botulism-like illnesses possibly related to counterfeit botulinum toxin reported in Illinois and Tennessee, prompted the American Society for Dermatologic Surgery Association (ASDSA) to call on states to increase oversight of medical care in all settings, including medical spas, the ASDSA announced on April 12.

The CDC summary advises clinicians to consider the possibility of adverse effects from botulinum toxin injection, including for cosmetic reasons, when patients present with signs and symptoms consistent with botulism near the injection site. Symptoms of botulism include blurry or double vision, drooping eyelids, difficulty swallowing, difficulty breathing, and muscle weakness.

For people who are considering botulinum toxin for cosmetic or medical reasons, recommendations from the CDC include asking the provider and setting, such as a clinic or spa, if they are licensed and trained to provide these injections, and to ask if the product is approved by the FDA and from a reliable source, and, “if in doubt, don’t get the injection.”

This ‘Should Never Happen’

“The report of people getting botulism from botulinum toxin injections is frightening, and should never happen,” Lawrence J. Green, MD, clinical professor of dermatology, George Washington University, Washington, told this news organization.

Dr. Green

These reports show “how important it is to receive botulinum toxin injections only in a medical office, and from or under the direction of a qualified, trained, and licensed individual, like a board certified dermatologist,” added Dr. Green, who practices in Rockville, Maryland. “Other types of practitioners may not adhere to the same standards of professionalism, especially not always putting patient safety first.”

Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
 

For cases of suspected systemic botulism, the CDC recommends calling the local or state health department for consultation and antitoxin release (as well as information on reporting adverse events). Alternatively, the 24/7 phone number for the CDC clinical botulism service is 770-488-7100.

At least 19 people from nine states have reported serious reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in non-healthcare settings, such as homes and spas, according to an announcement of an investigation into these reports from the Centers for Disease Control and Prevention posted online April 15.

Reactions have included blurry vision, double vision, drooping eyelids, difficult swallowing or breathing, and other symptoms of botulism.

Of the 19 individuals — all of whom identified as female and had a mean age of 39 years — 9 (60%) were hospitalized and 4 (21%) were treated with botulism antitoxin because of concerns that the botulinum toxin could have spread beyond the injection site. Also, five were tested for botulism and their results were negative.

The CDC, several state and local health departments, and the US Food and Drug Administration (FDA) are investigating these reports, according to the announcement.

States reporting these cases include Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington. According to the CDC summary, some of the individuals “received injections with counterfeit products or products with unverified sources. Investigation into the sources of these products is ongoing.” All but one report involved receiving botulinum toxin injections for cosmetic purposes.

Recent cases of botulism-like illnesses possibly related to counterfeit botulinum toxin reported in Illinois and Tennessee, prompted the American Society for Dermatologic Surgery Association (ASDSA) to call on states to increase oversight of medical care in all settings, including medical spas, the ASDSA announced on April 12.

The CDC summary advises clinicians to consider the possibility of adverse effects from botulinum toxin injection, including for cosmetic reasons, when patients present with signs and symptoms consistent with botulism near the injection site. Symptoms of botulism include blurry or double vision, drooping eyelids, difficulty swallowing, difficulty breathing, and muscle weakness.

For people who are considering botulinum toxin for cosmetic or medical reasons, recommendations from the CDC include asking the provider and setting, such as a clinic or spa, if they are licensed and trained to provide these injections, and to ask if the product is approved by the FDA and from a reliable source, and, “if in doubt, don’t get the injection.”

This ‘Should Never Happen’

“The report of people getting botulism from botulinum toxin injections is frightening, and should never happen,” Lawrence J. Green, MD, clinical professor of dermatology, George Washington University, Washington, told this news organization.

Dr. Green

These reports show “how important it is to receive botulinum toxin injections only in a medical office, and from or under the direction of a qualified, trained, and licensed individual, like a board certified dermatologist,” added Dr. Green, who practices in Rockville, Maryland. “Other types of practitioners may not adhere to the same standards of professionalism, especially not always putting patient safety first.”

Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
 

For cases of suspected systemic botulism, the CDC recommends calling the local or state health department for consultation and antitoxin release (as well as information on reporting adverse events). Alternatively, the 24/7 phone number for the CDC clinical botulism service is 770-488-7100.

SAN DIEGO — The number of solid organ transplant survivors is on the rise, a dermatologist told colleagues, and they face unique challenges from higher risks for skin cancer and skin infections because of their suppressed immune systems.

“There are over 450,000 people with a solid organ transplant living in the United States. If you do the math, that works out to about 40 organ transplant recipients for every dermatologist, so there’s a lot of them out there for us to take care of,” Sean Christensen, MD, PhD, associate professor of dermatology, Yale University, New Haven, Connecticut, said at the annual meeting of the American Academy of Dermatology (AAD). “If we expand that umbrella to include all types of immunosuppression, that’s over 4 million adults in the US.”

Dr. Christensen encouraged dermatologists to be aware of the varying risks for immunosuppressive drugs and best screening practices for these patients, and to take advantage of a validated skin cancer risk assessment tool for transplant patients.

During his presentation, he highlighted five classes of immunosuppressive drugs and their associated skin cancer risks:

• Calcineurin inhibitors (tacrolimus or cyclosporine), which cause severe immune suppression and pose a severe skin cancer risk. They may also cause gingival hyperplasia and sebaceous hyperplasia.
• Antimetabolites (mycophenolate mofetil or azathioprine), which cause moderate to severe immune suppression and pose a severe skin cancer risk.
• Mammalian target of rapamycin inhibitors (sirolimus or everolimus), which cause severe immune suppression and pose a moderate skin cancer risk. They also impair wound healing.
• Corticosteroids (prednisone), which cause mild to severe immune suppression and pose a minimal skin cancer risk.
• A decoy receptor protein (belatacept), which causes severe immune suppression and poses a mild skin cancer risk.

“Most of our solid-organ transplant recipients will be on both a calcineurin inhibitor and an antimetabolite,” Dr. Christensen said. “In addition to the skin cancer risk associated with immunosuppression, there is an additive risk” that is a direct effect of these medications on the skin. “That means our transplant recipients have a severely and disproportionate increase in skin cancer,” he noted.

Up to half of solid-organ transplant recipients will develop skin cancer, Dr. Christensen said. These patients have a sixfold to 10-fold increased risk for basal cell carcinoma (BCC), a 35- to 65-fold increased risk for squamous cell carcinoma (SCC), a twofold to sevenfold increased risk for melanoma, and a 16- to 100-fold increased risk for Merkel cell carcinoma.

Transplant recipients with SCC, he said, have a twofold to threefold higher risk for metastasis (4%-8% nodal metastasis) and twofold to fivefold higher risk for death (2%-7% mortality) from SCC.

As for other kinds of immunosuppression, HIV positivity, treatment with 6-mercaptopurine or azathioprine (for inflammatory bowel disease and rheumatoid arthritis), and antitumor necrosis factor agents (for psoriasis, inflammatory bowel disease, and rheumatoid arthritis) have been linked in studies to a higher risk for nonmelanoma skin cancer.

Dr. Christensen also highlighted graft-versus-host disease (GVHD). “It does look like there is a disproportionate and increased risk of SCC of the oropharynx and of the skin in patients who have chronic GVHD. This is probably due to a combination of both the immunosuppressive medications that are required but also from chronic and ongoing inflammation in the skin.”

Chronic GVHD has been linked to a 5.3-fold increase in the risk for SCC and a twofold increase in the risk for BCC, he added.

Moreover, new medications for treating GVHD have been linked to an increased risk for SCC, including a 3.2-fold increased risk for SCC associated with ruxolitinib, a Janus kinase (JAK) 1 and JAK2 inhibitor, in a study of patients with polycythemia vera and myelofibrosis; and a case report of SCC in a patient treated with belumosudil, a rho-associated coiled-coil-containing protein kinase-2 kinase inhibitor, for chronic GVHD. Risk for SCC appears to increase based on duration of use with voriconazole, an antifungal, which, he said, is a potent photosynthesizer.

Dr. Christensen also noted the higher risk for infections in immunocompromised patients and added that these patients can develop inflammatory disease despite immunosuppression:

Staphylococcus, Streptococcus, and Dermatophytes are the most common skin pathogens in these patients. There’s a significantly increased risk for reactivation of herpes simplex, varicella-zoster viruses, and cytomegalovirus. Opportunistic and disseminated fungal infections, such as mycobacteria, Candida, histoplasma, cryptococcus, aspergillus, and mucormycosis, can also appear.

More than 80% of transplant recipients develop molluscum and verruca vulgaris/human papillomavirus infection. They may also develop noninfectious inflammatory dermatoses.

Risk Calculator

What can dermatologists do to help transplant patients? Dr. Christensen highlighted the Skin and UV Neoplasia Transplant Risk Assessment Calculator, which predicts skin cancer risk based on points given for race, gender, skin cancer history, age at transplant, and site of transplant.

The tool, validated in a 2023 study of transplant recipients in Europe, is available online and as an app. It makes recommendations to users about when patients should have initial skin screening exams. Those with the most risk — 45% at 5 years — should be screened within 6 months. “We can use [the tool] to triage these cases when we first meet them and get them plugged into the appropriate care,” Dr. Christensen said.

He recommended seeing high-risk patients at least annually. Patients with a prior SCC and a heavy burden of actinic keratosis should be followed more frequently, he said.

In regard to SCC, he highlighted a 2024 study of solid organ transplant recipients that found the risk for a second SCC after a first SCC was 74%, the risk for a third SCC after a second SCC was 83%, and the risk for another SCC after five SCCs was 92%.

Dr. Christensen disclosed relationships with Canfield Scientific Inc. (consulting), Inhibitor Therapeutics (advisory board), and Sol-Gel Technologies Ltd. (grants/research funding).

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

SAN DIEGO — The number of solid organ transplant survivors is on the rise, a dermatologist told colleagues, and they face unique challenges from higher risks for skin cancer and skin infections because of their suppressed immune systems.

“There are over 450,000 people with a solid organ transplant living in the United States. If you do the math, that works out to about 40 organ transplant recipients for every dermatologist, so there’s a lot of them out there for us to take care of,” Sean Christensen, MD, PhD, associate professor of dermatology, Yale University, New Haven, Connecticut, said at the annual meeting of the American Academy of Dermatology (AAD). “If we expand that umbrella to include all types of immunosuppression, that’s over 4 million adults in the US.”

Dr. Christensen encouraged dermatologists to be aware of the varying risks for immunosuppressive drugs and best screening practices for these patients, and to take advantage of a validated skin cancer risk assessment tool for transplant patients.

During his presentation, he highlighted five classes of immunosuppressive drugs and their associated skin cancer risks:

• Calcineurin inhibitors (tacrolimus or cyclosporine), which cause severe immune suppression and pose a severe skin cancer risk. They may also cause gingival hyperplasia and sebaceous hyperplasia.
• Antimetabolites (mycophenolate mofetil or azathioprine), which cause moderate to severe immune suppression and pose a severe skin cancer risk.
• Mammalian target of rapamycin inhibitors (sirolimus or everolimus), which cause severe immune suppression and pose a moderate skin cancer risk. They also impair wound healing.
• Corticosteroids (prednisone), which cause mild to severe immune suppression and pose a minimal skin cancer risk.
• A decoy receptor protein (belatacept), which causes severe immune suppression and poses a mild skin cancer risk.

“Most of our solid-organ transplant recipients will be on both a calcineurin inhibitor and an antimetabolite,” Dr. Christensen said. “In addition to the skin cancer risk associated with immunosuppression, there is an additive risk” that is a direct effect of these medications on the skin. “That means our transplant recipients have a severely and disproportionate increase in skin cancer,” he noted.

Up to half of solid-organ transplant recipients will develop skin cancer, Dr. Christensen said. These patients have a sixfold to 10-fold increased risk for basal cell carcinoma (BCC), a 35- to 65-fold increased risk for squamous cell carcinoma (SCC), a twofold to sevenfold increased risk for melanoma, and a 16- to 100-fold increased risk for Merkel cell carcinoma.

Transplant recipients with SCC, he said, have a twofold to threefold higher risk for metastasis (4%-8% nodal metastasis) and twofold to fivefold higher risk for death (2%-7% mortality) from SCC.

As for other kinds of immunosuppression, HIV positivity, treatment with 6-mercaptopurine or azathioprine (for inflammatory bowel disease and rheumatoid arthritis), and antitumor necrosis factor agents (for psoriasis, inflammatory bowel disease, and rheumatoid arthritis) have been linked in studies to a higher risk for nonmelanoma skin cancer.

Dr. Christensen also highlighted graft-versus-host disease (GVHD). “It does look like there is a disproportionate and increased risk of SCC of the oropharynx and of the skin in patients who have chronic GVHD. This is probably due to a combination of both the immunosuppressive medications that are required but also from chronic and ongoing inflammation in the skin.”

Chronic GVHD has been linked to a 5.3-fold increase in the risk for SCC and a twofold increase in the risk for BCC, he added.

Moreover, new medications for treating GVHD have been linked to an increased risk for SCC, including a 3.2-fold increased risk for SCC associated with ruxolitinib, a Janus kinase (JAK) 1 and JAK2 inhibitor, in a study of patients with polycythemia vera and myelofibrosis; and a case report of SCC in a patient treated with belumosudil, a rho-associated coiled-coil-containing protein kinase-2 kinase inhibitor, for chronic GVHD. Risk for SCC appears to increase based on duration of use with voriconazole, an antifungal, which, he said, is a potent photosynthesizer.

Dr. Christensen also noted the higher risk for infections in immunocompromised patients and added that these patients can develop inflammatory disease despite immunosuppression:

Staphylococcus, Streptococcus, and Dermatophytes are the most common skin pathogens in these patients. There’s a significantly increased risk for reactivation of herpes simplex, varicella-zoster viruses, and cytomegalovirus. Opportunistic and disseminated fungal infections, such as mycobacteria, Candida, histoplasma, cryptococcus, aspergillus, and mucormycosis, can also appear.

More than 80% of transplant recipients develop molluscum and verruca vulgaris/human papillomavirus infection. They may also develop noninfectious inflammatory dermatoses.

Risk Calculator

What can dermatologists do to help transplant patients? Dr. Christensen highlighted the Skin and UV Neoplasia Transplant Risk Assessment Calculator, which predicts skin cancer risk based on points given for race, gender, skin cancer history, age at transplant, and site of transplant.

The tool, validated in a 2023 study of transplant recipients in Europe, is available online and as an app. It makes recommendations to users about when patients should have initial skin screening exams. Those with the most risk — 45% at 5 years — should be screened within 6 months. “We can use [the tool] to triage these cases when we first meet them and get them plugged into the appropriate care,” Dr. Christensen said.

He recommended seeing high-risk patients at least annually. Patients with a prior SCC and a heavy burden of actinic keratosis should be followed more frequently, he said.

In regard to SCC, he highlighted a 2024 study of solid organ transplant recipients that found the risk for a second SCC after a first SCC was 74%, the risk for a third SCC after a second SCC was 83%, and the risk for another SCC after five SCCs was 92%.

Dr. Christensen disclosed relationships with Canfield Scientific Inc. (consulting), Inhibitor Therapeutics (advisory board), and Sol-Gel Technologies Ltd. (grants/research funding).

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

SAN DIEGO — The number of solid organ transplant survivors is on the rise, a dermatologist told colleagues, and they face unique challenges from higher risks for skin cancer and skin infections because of their suppressed immune systems.

“There are over 450,000 people with a solid organ transplant living in the United States. If you do the math, that works out to about 40 organ transplant recipients for every dermatologist, so there’s a lot of them out there for us to take care of,” Sean Christensen, MD, PhD, associate professor of dermatology, Yale University, New Haven, Connecticut, said at the annual meeting of the American Academy of Dermatology (AAD). “If we expand that umbrella to include all types of immunosuppression, that’s over 4 million adults in the US.”

Dr. Christensen encouraged dermatologists to be aware of the varying risks for immunosuppressive drugs and best screening practices for these patients, and to take advantage of a validated skin cancer risk assessment tool for transplant patients.

During his presentation, he highlighted five classes of immunosuppressive drugs and their associated skin cancer risks:

• Calcineurin inhibitors (tacrolimus or cyclosporine), which cause severe immune suppression and pose a severe skin cancer risk. They may also cause gingival hyperplasia and sebaceous hyperplasia.
• Antimetabolites (mycophenolate mofetil or azathioprine), which cause moderate to severe immune suppression and pose a severe skin cancer risk.
• Mammalian target of rapamycin inhibitors (sirolimus or everolimus), which cause severe immune suppression and pose a moderate skin cancer risk. They also impair wound healing.
• Corticosteroids (prednisone), which cause mild to severe immune suppression and pose a minimal skin cancer risk.
• A decoy receptor protein (belatacept), which causes severe immune suppression and poses a mild skin cancer risk.

“Most of our solid-organ transplant recipients will be on both a calcineurin inhibitor and an antimetabolite,” Dr. Christensen said. “In addition to the skin cancer risk associated with immunosuppression, there is an additive risk” that is a direct effect of these medications on the skin. “That means our transplant recipients have a severely and disproportionate increase in skin cancer,” he noted.

Up to half of solid-organ transplant recipients will develop skin cancer, Dr. Christensen said. These patients have a sixfold to 10-fold increased risk for basal cell carcinoma (BCC), a 35- to 65-fold increased risk for squamous cell carcinoma (SCC), a twofold to sevenfold increased risk for melanoma, and a 16- to 100-fold increased risk for Merkel cell carcinoma.

Transplant recipients with SCC, he said, have a twofold to threefold higher risk for metastasis (4%-8% nodal metastasis) and twofold to fivefold higher risk for death (2%-7% mortality) from SCC.

As for other kinds of immunosuppression, HIV positivity, treatment with 6-mercaptopurine or azathioprine (for inflammatory bowel disease and rheumatoid arthritis), and antitumor necrosis factor agents (for psoriasis, inflammatory bowel disease, and rheumatoid arthritis) have been linked in studies to a higher risk for nonmelanoma skin cancer.

Dr. Christensen also highlighted graft-versus-host disease (GVHD). “It does look like there is a disproportionate and increased risk of SCC of the oropharynx and of the skin in patients who have chronic GVHD. This is probably due to a combination of both the immunosuppressive medications that are required but also from chronic and ongoing inflammation in the skin.”

Chronic GVHD has been linked to a 5.3-fold increase in the risk for SCC and a twofold increase in the risk for BCC, he added.

Moreover, new medications for treating GVHD have been linked to an increased risk for SCC, including a 3.2-fold increased risk for SCC associated with ruxolitinib, a Janus kinase (JAK) 1 and JAK2 inhibitor, in a study of patients with polycythemia vera and myelofibrosis; and a case report of SCC in a patient treated with belumosudil, a rho-associated coiled-coil-containing protein kinase-2 kinase inhibitor, for chronic GVHD. Risk for SCC appears to increase based on duration of use with voriconazole, an antifungal, which, he said, is a potent photosynthesizer.

Dr. Christensen also noted the higher risk for infections in immunocompromised patients and added that these patients can develop inflammatory disease despite immunosuppression:

Staphylococcus, Streptococcus, and Dermatophytes are the most common skin pathogens in these patients. There’s a significantly increased risk for reactivation of herpes simplex, varicella-zoster viruses, and cytomegalovirus. Opportunistic and disseminated fungal infections, such as mycobacteria, Candida, histoplasma, cryptococcus, aspergillus, and mucormycosis, can also appear.

More than 80% of transplant recipients develop molluscum and verruca vulgaris/human papillomavirus infection. They may also develop noninfectious inflammatory dermatoses.

Risk Calculator

What can dermatologists do to help transplant patients? Dr. Christensen highlighted the Skin and UV Neoplasia Transplant Risk Assessment Calculator, which predicts skin cancer risk based on points given for race, gender, skin cancer history, age at transplant, and site of transplant.

The tool, validated in a 2023 study of transplant recipients in Europe, is available online and as an app. It makes recommendations to users about when patients should have initial skin screening exams. Those with the most risk — 45% at 5 years — should be screened within 6 months. “We can use [the tool] to triage these cases when we first meet them and get them plugged into the appropriate care,” Dr. Christensen said.

He recommended seeing high-risk patients at least annually. Patients with a prior SCC and a heavy burden of actinic keratosis should be followed more frequently, he said.

In regard to SCC, he highlighted a 2024 study of solid organ transplant recipients that found the risk for a second SCC after a first SCC was 74%, the risk for a third SCC after a second SCC was 83%, and the risk for another SCC after five SCCs was 92%.

Dr. Christensen disclosed relationships with Canfield Scientific Inc. (consulting), Inhibitor Therapeutics (advisory board), and Sol-Gel Technologies Ltd. (grants/research funding).

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

KOH analysis of the scales from the scalp areas revealed no fungal elements. Given the observed erythema and scaling, a punch biopsy was conducted. Histopathological examination of the biopsy sample displayed interface inflammation affecting both the infundibular and lower portions of hair follicles. The presence of folliculosebaceous units transitioning from intermediate to terminal size follicles was noted. A perifollicular, peri eccrine, superficial, and deep perivascular lymphoplasmacytic infiltrate was identified, alongside increased dermal mucin, findings consistent with a diagnosis of discoid lupus erythematosus.

Subsequent laboratory investigations were largely unremarkable, except for an elevated ANA titer (1:320, with a speckled pattern). The patient was initiated on a treatment regimen comprising intralesional triamcinolone and oral hydroxychloroquine (Plaquenil).

Dr. Matiz

Discussion

Pediatric discoid lupus erythematosus (DLE) is a rare but chronic autoimmune condition, representing one of the most prevalent forms of cutaneous lupus erythematosus. It predominantly affects adults, yet pediatric cases account for 5%-7% of DLE diagnoses, with a significant predominance in females. Pediatric scalp DLE is particularly concerning due to its potential for causing scarring and permanent hair loss, which can significantly impact the psychological wellbeing of affected children.

The pathogenesis of DLE is multifactorial, involving genetic predispositions, environmental factors like UV light exposure, and immunological mechanisms leading to skin damage.

In children, DLE typically presents as well-demarcated, erythematous plaques with scale and follicular plugging, primarily affecting the scalp. Lesions may also exhibit changes in pigmentation, atrophy, and telangiectasia. The scalp involvement often leads to scarring alopecia, which can be distressing for pediatric patients. Unlike systemic lupus erythematosus (SLE), DLE is usually limited to the skin without systemic involvement. The progression of DLE to systemic lupus erythematosus in children has been previously described to be 22.2%. In a recent report of 201 pediatric cases of DLE, 12% of the cases progressed to systemic lupus erythematosus (SLE) and 14.5% had concurrent SLE. The onset of symptoms before the age of 10 years was the only statistically significant predictor for progression to SLE. Pruritus is a common symptom and may be correlated with disease activity.

The differential diagnosis for this patient encompassed a variety of conditions, including tinea capitis, alopecia areata, trichotillomania, and lichen planopilaris, each considered based on clinical presentation but ultimately excluded through clinical, microscopic, and biopsy findings.

Conclusion

The prognosis for pediatric scalp DLE can be favorable with timely and appropriate management, underscoring the importance of early diagnosis and intervention to prevent scarring and hair loss. However, ongoing surveillance is crucial for monitoring potential progression to systemic lupus erythematosus, albeit a low-risk transformation.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

References

1. George PM and Tunnessen WW. Childhood discoid lupus erythematosus. Arch Dermatol. 1993;129(5):613-617.

2. Hawat T et al. Pediatric discoid lupus erythematosus: Short report. Dermatol Ther. 2022 Jan;35(1):e15170. doi: 10.1111/dth.15170.

3. Arkin LM et al. Practice-based differences in paediatric discoid lupus erythematosus. Br J Dermatol. 2019 Oct;181(4):805-810. doi: 10.1111/bjd.17780.

KOH analysis of the scales from the scalp areas revealed no fungal elements. Given the observed erythema and scaling, a punch biopsy was conducted. Histopathological examination of the biopsy sample displayed interface inflammation affecting both the infundibular and lower portions of hair follicles. The presence of folliculosebaceous units transitioning from intermediate to terminal size follicles was noted. A perifollicular, peri eccrine, superficial, and deep perivascular lymphoplasmacytic infiltrate was identified, alongside increased dermal mucin, findings consistent with a diagnosis of discoid lupus erythematosus.

Subsequent laboratory investigations were largely unremarkable, except for an elevated ANA titer (1:320, with a speckled pattern). The patient was initiated on a treatment regimen comprising intralesional triamcinolone and oral hydroxychloroquine (Plaquenil).

Dr. Matiz

Discussion

Pediatric discoid lupus erythematosus (DLE) is a rare but chronic autoimmune condition, representing one of the most prevalent forms of cutaneous lupus erythematosus. It predominantly affects adults, yet pediatric cases account for 5%-7% of DLE diagnoses, with a significant predominance in females. Pediatric scalp DLE is particularly concerning due to its potential for causing scarring and permanent hair loss, which can significantly impact the psychological wellbeing of affected children.

The pathogenesis of DLE is multifactorial, involving genetic predispositions, environmental factors like UV light exposure, and immunological mechanisms leading to skin damage.

In children, DLE typically presents as well-demarcated, erythematous plaques with scale and follicular plugging, primarily affecting the scalp. Lesions may also exhibit changes in pigmentation, atrophy, and telangiectasia. The scalp involvement often leads to scarring alopecia, which can be distressing for pediatric patients. Unlike systemic lupus erythematosus (SLE), DLE is usually limited to the skin without systemic involvement. The progression of DLE to systemic lupus erythematosus in children has been previously described to be 22.2%. In a recent report of 201 pediatric cases of DLE, 12% of the cases progressed to systemic lupus erythematosus (SLE) and 14.5% had concurrent SLE. The onset of symptoms before the age of 10 years was the only statistically significant predictor for progression to SLE. Pruritus is a common symptom and may be correlated with disease activity.

The differential diagnosis for this patient encompassed a variety of conditions, including tinea capitis, alopecia areata, trichotillomania, and lichen planopilaris, each considered based on clinical presentation but ultimately excluded through clinical, microscopic, and biopsy findings.

Conclusion

The prognosis for pediatric scalp DLE can be favorable with timely and appropriate management, underscoring the importance of early diagnosis and intervention to prevent scarring and hair loss. However, ongoing surveillance is crucial for monitoring potential progression to systemic lupus erythematosus, albeit a low-risk transformation.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

References

1. George PM and Tunnessen WW. Childhood discoid lupus erythematosus. Arch Dermatol. 1993;129(5):613-617.

2. Hawat T et al. Pediatric discoid lupus erythematosus: Short report. Dermatol Ther. 2022 Jan;35(1):e15170. doi: 10.1111/dth.15170.

3. Arkin LM et al. Practice-based differences in paediatric discoid lupus erythematosus. Br J Dermatol. 2019 Oct;181(4):805-810. doi: 10.1111/bjd.17780.

KOH analysis of the scales from the scalp areas revealed no fungal elements. Given the observed erythema and scaling, a punch biopsy was conducted. Histopathological examination of the biopsy sample displayed interface inflammation affecting both the infundibular and lower portions of hair follicles. The presence of folliculosebaceous units transitioning from intermediate to terminal size follicles was noted. A perifollicular, peri eccrine, superficial, and deep perivascular lymphoplasmacytic infiltrate was identified, alongside increased dermal mucin, findings consistent with a diagnosis of discoid lupus erythematosus.

Subsequent laboratory investigations were largely unremarkable, except for an elevated ANA titer (1:320, with a speckled pattern). The patient was initiated on a treatment regimen comprising intralesional triamcinolone and oral hydroxychloroquine (Plaquenil).

Dr. Matiz

Discussion

Pediatric discoid lupus erythematosus (DLE) is a rare but chronic autoimmune condition, representing one of the most prevalent forms of cutaneous lupus erythematosus. It predominantly affects adults, yet pediatric cases account for 5%-7% of DLE diagnoses, with a significant predominance in females. Pediatric scalp DLE is particularly concerning due to its potential for causing scarring and permanent hair loss, which can significantly impact the psychological wellbeing of affected children.

The pathogenesis of DLE is multifactorial, involving genetic predispositions, environmental factors like UV light exposure, and immunological mechanisms leading to skin damage.

In children, DLE typically presents as well-demarcated, erythematous plaques with scale and follicular plugging, primarily affecting the scalp. Lesions may also exhibit changes in pigmentation, atrophy, and telangiectasia. The scalp involvement often leads to scarring alopecia, which can be distressing for pediatric patients. Unlike systemic lupus erythematosus (SLE), DLE is usually limited to the skin without systemic involvement. The progression of DLE to systemic lupus erythematosus in children has been previously described to be 22.2%. In a recent report of 201 pediatric cases of DLE, 12% of the cases progressed to systemic lupus erythematosus (SLE) and 14.5% had concurrent SLE. The onset of symptoms before the age of 10 years was the only statistically significant predictor for progression to SLE. Pruritus is a common symptom and may be correlated with disease activity.

The differential diagnosis for this patient encompassed a variety of conditions, including tinea capitis, alopecia areata, trichotillomania, and lichen planopilaris, each considered based on clinical presentation but ultimately excluded through clinical, microscopic, and biopsy findings.

Conclusion

The prognosis for pediatric scalp DLE can be favorable with timely and appropriate management, underscoring the importance of early diagnosis and intervention to prevent scarring and hair loss. However, ongoing surveillance is crucial for monitoring potential progression to systemic lupus erythematosus, albeit a low-risk transformation.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

References

1. George PM and Tunnessen WW. Childhood discoid lupus erythematosus. Arch Dermatol. 1993;129(5):613-617.

2. Hawat T et al. Pediatric discoid lupus erythematosus: Short report. Dermatol Ther. 2022 Jan;35(1):e15170. doi: 10.1111/dth.15170.

3. Arkin LM et al. Practice-based differences in paediatric discoid lupus erythematosus. Br J Dermatol. 2019 Oct;181(4):805-810. doi: 10.1111/bjd.17780.