Dermatology Month in Review: July 2024

The field of dermatology has seen a variety of new developments in the first half of 2024, and the month of July alone has been a significant time for research and other news in this space.

From decisions by the US Food and Drug Administration (FDA) to new research on treatment options for atopic dermatitis, the world of dermatology has seen a wide variety of developments. Here, the HCPLive editorial team highlight some of the biggest stories from July 2024:

FDA News and Updates

Arcutis Submits sNDA for Roflumilast Foam as Treatment for Scalp, Body Psoriasis

Arcutis Biotherapeutics announced the submission of a supplemental new drug application (sNDA) to the FDA for roflumilast (Zoryve) foam 0.3%—a next-generation phosphodiesterase-4 (PDE4) inhibitor intended for patients with scalp and body psoriasis in the age range of 12 and older. The drug is formulated for once-daily use among those with this skin condition, a form known to affect 40% of 9 million Americans with plaque psoriasis.

“Nearly half of all individuals with plaque psoriasis have involvement of the scalp,” Melinda Gooderham, MSc, MD, FRCPC, clinical trial investigator, said in a statement. “Hair-bearing areas present unique treatment challenges that are not easily addressed with creams or ointments. Individuals with plaque psoriasis need steroid-free treatment options that clear plaques anywhere on the body and relieve burdensome symptoms, such as itch and flaking.”

FDA Approves Deuruxolitinib for Treatment of Severe Alopecia Areata

Another example of FDA news covered in July was Sun Pharmaceutical Industries Limited’s announcement of deuruxolitinib’s (Lesqselvi) approval for adults with severe alopecia areata at an 8 mg dose administered twice-per-day. This addition to the alopecia areata treatment armamentarium is an oral selective Janus Kinase (JAK) JAK1 and JAK2 inhibitor. The drug is formulated to disrupt these pathways which are known to contribute to hair loss among severe alopecia areata patients.

“For many people with severe alopecia areata, early intervention with effective treatment is critical,” Natasha Mesinkovska, MD, PhD, associate professor and vice chair for clinical research of dermatology at the University of California, Irvine, said in a statement. “An oral JAK that delivers proven results will be impactful for the alopecia areata community.”

Roflumilast Cream Receives FDA Approval for Atopic Dermatitis

Another event covered in July was Arcutis Biotherapeutics’s announcement ofthe roflumilast cream 0.15% approval by the FDA for individuals in the age range of 6 years and older with moderate-to-severe atopic dermatitis. The drug is a steroid-free, topical option which is a selective phosphodiesterase-4 (PDE4) inhibitor, designed to be non-greasy and quickly-absorbed.

Positive results from INTEGUMENT studies regarding roflumilast treatment once-daily showed that treatment had resulted in rapid clearance of participants’ atopic dermatitis as well as significant reductions in itch within 24 hours. After these findings had been released, the company submitted the drug’s supplemental New Drug Application (sNDA) to the FDA in September 2023.

Atopic Dermatitis News

Delgocitinib Cream Effective Over 16 Weeks for Chronic Hand Eczema

In atopic dermatitis news, LEO Pharma A/S announced the publishing of new phase 3 results from the DELTA 1 and DELTA 2 clinical trials, the conclusions of which showed that delgocitinib cream was superior to vehicle and well tolerated over the course of 16 weeks among chronic hand eczema patients. These findings on the investigational topical pan-JAK inhibitor, published in the Lancet, concerned those with moderate to severe chronic hand eczema which can persist for over 3 months and recur at least 2 times per-year.

“Historically, (chronic hand eczema) has been under researched, so the publication of the DELTA 1 and 2 trials in The Lancet is a positive step towards highlighting the condition, and in turn indicates the increased quality and rate of research in the space,” Robert Bissonnette, MD, lead author, chief executive officer and medical director of Innovaderm Research, said in a statement. “Publication of milestones like this have a valuable role in our efforts to improve the day-to-day reality of those living with (chronic hand eczema).”

Lebrikizumab Shown to Have Comparable Efficacy to Dupilumab for Eczema

In another study covered in July, lebrikizumab was shown to have similar efficacy to dupilumab for a short-term treatment period among adults with atopic dermatitis. These conclusions could potentially allow dermatologists and patients to use additional comparisons during their decisions regarding treatment for the skin condition.

Duplicate and random-effects bayesian network meta-analyses led to these findings, and this research was by a team of investigators led by Aaron M. Drucker, MD, from the University of Toronto department of medicine, sought to compare the most recently FDA-approved biologic with other systemic options.

“This update to our living systematic review and (network meta-analysis) compares the efficacy and safety of systemic immunomodulatory treatments for atopic dermatitis, including lebrikizumab,” Drucker and colleagues noted.

Other Developments

Ruxolitinib Cream Led to Meaningful Repigmentation Across Different Body Regions

In other news covered in July, ruxolitinib for patients with vitiligo led to meaningful repigmentation over 52 weeks across patients’ different bodily regions. These conclusions were the results of a pooled analysis of the TRuE-V1/TRuE-V2 phase 3 studies led by Thierry Passeron, from the Centre Hospitalier Universitaire de Nice at the Université Côte d'Azur in France.

The investigators noted repigmentation’s value as a treatment goal among patients. They also added that repigmentation likelihood is affected by the location of patients’ vitiligo lesions.

“Ruxolitinib cream, a topical Janus kinase (JAK) 1/JAK2 inhibitor and the first approved repigmentation therapy for vitiligo, was statistically superior to vehicle at Week 24 and was well tolerated in two Phase 3 studies of adults and adolescents ≥12 years with nonsegmental vitiligo…” Passeron and colleagues wrote.

Omega-3 Fatty Acid Deficiency Could Be Driver of Acne Severity, Study Finds

Another development in July was a study demonstrating that deficits in omega-3 fatty acids could perform a significant role in acne severity. The findings resulted from a single-site, interventional study, during which participants adhered to a Mediterranean diet.

Omega-3 fatty acid supplementation was linked with quality of life benefits, and the research team concluded that improvements in patients’ inflammatory and noninflammatory lesions were observed among those with mild to moderate acne without the use of acne medications.

The team sought to evaluate the impact of raising EPA/DHA levels into a target range through the use of dietary recommendations as well as oral supplementation of algae-derived EPA/DHA. HS-omega-3 index measurement and the achievement of mean levels to the target range using dietary recommendations were the primary outcomes of interest.