Dermatology Month in Review: May 2025

Every month, the HCPLive editorial team publishes a new iteration of our Month in Review series, during which a summary provides several highlights of the most notable news coverage from the month in each medical subfield. Here, the team spotlights some of the most significant stories in the field of dermatology.

The dermatology space in May featured a set of notable US Food and Drug Administration (FDA) approvals—specifically roflumilast foam 0.3% for scalp and body psoriasis and a novel blue light device for actinic keratosis—as well as a variety of new data on treatments for such conditions as psoriasis and alopecia areata. The 2 regulatory milestones, along with emerging clinical research and expert commentary presented throughout the month, marked important steps forward in the management of chronic inflammatory and pre-cancerous skin conditions.

FDA News

FDA Approves Once-Daily Roflumilast (ZORYVE) Foam 0.3% for Scalp and Body Psoriasis

In 1 of the most notable FDA decisions announced in May, roflumilast (Zoryve) foam 0.3% was approved as a once-daily topical therapy for patients with plaque psoriasis who were adults or adolescents a(ged 12 years and older). Clinical data had demonstrated the drug’s efficacy in clearing plaques and providing rapid itch relief, with positive results in phase 2 and 3 analyses.

FDA Approves New Blue Light Tool for Actinic Keratosis

The FDA also approved the premarket application (PMA) for BLU-U Blue Light Photodynamic Therapy (PDT) Illuminators, which features light-emitting diode (LED) light panels rather than the fluorescent tubes implemented in prior models, for actinic keratosis. The May 16 approval announcement for Sun Pharma’s LED BLU-U model, used in combination with aminolevulinic acid HCl (KERASTICK) topical solution, 20%, included a reference to its indication for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, and upper extremities.

Psoriasis Data

Study Supports Adalimumab Biosimilar Interchangeability for Patients with Psoriasis

Adalimumab biosimilar interchangeability was supported by findings reported on in May, along with data supporting the practice of non-medical switches between such biosimilars for those with psoriasis. These findings suggested that the most commonly registered reason for treatment discontinuation was a loss of effect.

New Phase 3 Data on Icotrokinra Suggest Efficacy for Genital, Scalp Psoriasis

Phase 3 data announced in May, released by Protagonist Therapeutics, Inc., showed that icotrokinra—an oral peptide designed to selectively inhibit the interleukin (IL)-23 receptor— for psoriasis resulted in 66% of individuals with scalp psoriasis and 77% of those with genital psoriasis achieving site-specific clear or almost clear skin at the 16-week mark.

Roflumilast Foam 0.3% for Scalp, Body Psoriasis Effective, Safe for Patients

Data from the phase 3 ARRECTOR study demonstrated that roflumilast foam 0.3% showed significant efficacy in treating patients with scalp and body psoriasis, with many of those treated achieving rapid symptom relief and high success rates in their clinical assessments. The phase 3 study involved 432 subjects, demonstrating the foam's safety and tolerability with low adverse event rates.

Alopecia Areata Data

Azathioprine Effective for Patients with Recalcitrant, Severe Alopecia Areata

Additional findings announced in May suggested that azathioprine was an efficacious systemic drug for those living with recalcitrant and severe alopecia areata, with significant efficacy observed and a mean hair regrowth of 92.69% noted over the course of 10 years. The analysis involved 63 participants, with baseline evaluations and regular monitoring done to ensure safety and efficacy.

Systemic Corticosteroids Enhance Baricitinib’s Efficacy for Alopecia Areata

In another story highlighted from May, findings indicated that systemic corticosteroids, along with baricitinib, enhanced the treatment’s efficacy for those living with severe alopecia areata and result in sustained benefits. This was especially observed among partial responders.