Top 5 Articles of the Month: December 2025

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1. Clascoterone 5% Delivers Strong Phase 3 Hair-Growth Results

Cosmo Pharmaceuticals reported promising topline results from 2 large phase 3 trials evaluating clascoterone 5% topical solution for male androgenetic alopecia (AGA), potentially representing the first new treatment mechanism for the condition in over 30 years. The trials, SCALP 1 and SCALP 2, enrolled 1,465 men and assessed Target Area Hair Count and patient-reported outcomes, showing statistically significant hair growth improvements versus vehicle, with alignment between objective measures and patient perception. Clascoterone works via local androgen receptor inhibition at the follicle, minimizing systemic exposure and avoiding the hormonal side effects of oral treatments. Safety was favorable, with treatment-emergent adverse events similar to vehicle. If approved, the therapy could expand options for men seeking a mechanistically distinct, topical solution for AGA, with regulatory submissions planned following completion of 12-month safety follow-up in Spring 2026.

2. Oral C5aR Inhibitor INF904 Shows Early Efficacy in HS and CSU Phase 2a Trials

InflaRx has reported encouraging topline results from its phase 2a study of INF904, an oral small-molecule C5a receptor antagonist, in patients with hidradenitis suppurativa (HS) and chronic spontaneous urticaria. Across both conditions, INF904 demonstrated early signs of efficacy comparable to established biologics, including reductions in inflammatory lesions, draining tunnels, and disease activity scores, alongside meaningful improvements in patient-reported outcomes such as pain and quality of life. The treatment was well tolerated, with no serious adverse events observed. These preliminary findings support further clinical development of INF904 and highlight the potential of complement pathway inhibition as a new oral therapeutic strategy in chronic inflammatory skin diseases.

3. Alys Pharmaceuticals Doses First Patient in Phase 1/1b Trial of ALY-301 for Chronic Urticaria

Alys Pharmaceuticals has dosed the first patient in a phase 1/1b study of ALY-301, a first-in-class, mast cell–selective c-Kit inhibitor being developed for cold urticaria, a model for chronic urticaria. ALY-301 is a bispecific antibody designed to selectively deplete mast cells while sparing other c-Kit–expressing cells, potentially enabling safe, long-term treatment of mast cell–driven diseases. The randomized, placebo-controlled trial will evaluate safety, tolerability, and pharmacology in both healthy volunteers and patients refractory to antihistamines, marking a key milestone in Alys’s mission to deliver precision-targeted therapies for chronic urticaria and related immune-dermatology conditions.

4. It's Not Genital Warts: A Clinician's Guide to Reassuring Men's Genital Concerns

This commentary humorously and insightfully highlights a key but often overlooked aspect of dermatology: patient reassurance, particularly for men concerned about genital skin lesions. Drawing a playful parallel to House’s iconic “It’s not Lupus,” Dobkin emphasizes the importance of demystifying genital lesions, many of which are benign and easily mistaken for genital warts. Pearly penile papules, Tyson’s glands, acrochordons, and angiokeratomas of Fordyce are common examples that frequently cause unnecessary anxiety. The piece underscores the vulnerability it takes for male patients to discuss these issues and the dermatologist’s role in normalizing the exam, providing reassurance, and fostering trust without judgment. Ultimately, it’s a witty reminder that in dermatology, even sensitive areas are just skin, and reassurance can be as therapeutically valuable as any procedure.

5. Patients with DIMIDs and Pandemic Risks

Research from the T2B! substudy evaluated how COVID-19 and vaccination affected patients with immune-mediated inflammatory diseases (DIMIDs), including atopic dermatitis (AD), psoriasis, and vitiligo. Patients with vitiligo had the highest reported COVID-19 incidence (51.1%), though severe outcomes were rare. Vaccination resulted in high seroconversion rates across all groups, reaching 100% in vitiligo patients after the second dose. Immunosuppressant therapy did not increase infection risk. While most patients tolerated infection and vaccination well, a minority—particularly those with progressive disease at baseline—reported increased DIMID activity afterward. The study underscores the importance of continued monitoring of DIMID progression following COVID-19 and vaccination.