Top 10 Articles of the Year: 2025

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1. Pelage's PP405 Demonstrates Efficacy in Phase 2a Trial for Androgenetic Alopecia

Pelage Pharmaceuticals announced positive results from a phase 2a trial of PP405, a topical therapy for androgenetic alopecia, showing it is safe, well-tolerated, and biologically active. The randomized, double-blind study of 78 adults demonstrated that PP405 not only increased hair density—31% of men with significant hair loss saw over 20% improvement at 8 weeks—but also promoted new hair growth in previously bald areas, with no systemic absorption detected. Unlike current treatments that target secondary causes, PP405 works directly on hair follicle stem cells, offering potential hair regeneration. Pelage plans to begin phase 3 trials in 2026 to further evaluate the therapy.

2. 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.

3. The Unprecedented Phase 1 Results of ET-02 for the Treatment of Androgenic Alopecia

Eirion Therapeutics announced highly promising results from its first-in-human clinical trial of ET-02, a topical treatment for androgenic alopecia, demonstrating strong safety and unprecedented efficacy, with visible hair regrowth observed as early as 5 weeks.

In an interview with Dermatology Times, CEO Jon Edelson, MD, emphasized that ET-02 produced 6 times more hair growth than placebo and surpassed 5% minoxidil’s 4-month results in just one month. Unlike current treatments that stimulate hair follicles or stem cells, ET-02 aims to correct underlying stem cell dysfunction, potentially restoring normal hair growth and even preventing future hair loss.

4. L'Oréal Issues Voluntary Recall of Benzoyl Peroxide Products Over Benzene Concerns

In March of this year, L’Oréal announced it is recalling all lots of its acne treatment Effaclar Duo in the US due to concerns over benzene contamination. The product, sold under the La Roche-Posay brand, contains benzoyl peroxide (BPO).

Valisure, an independent testing laboratory, first reported benzene contamination in several BPO-containing acne products more than a year ago, urging the US Food and Drug Administration (FDA) to take action.

5. Acne Burden is Growing in Young Women Across the World, New Study Finds

Recent data has analyzed global trends in acne burden in young women of reproductive age over the last 31 years. The burden has risen in all age groups and will continue to grow, with a forecast up to 2040. Results were extracted from Global Burden of Disease (GBD) data between 1990 and 2021.

“The growing availability of high-quality datasets, such as the GBD Study, provides unprecedented opportunities to assess disease distribution, trends, and determinants across populations. While acknowledging the limitations of modeled estimates—particularly in data-scarce regions—GBD remains the most comprehensive source for understanding global health patterns,” the researchers wrote.

6. DFD-29: The Journey to FDA Approval and a New Era in Rosacea Management

The FDA approval in November 2024 of 40-mg minocycline hydrochloride (Emrosi; Journey Medical Corporation), formerly known and hereafter referred to as DFD-29, marked a significant step forward in the treatment of rosacea.

The approval of these 40-mg extended-release capsules represents the first time an oral, systemic therapy has been given the green light in the US to address both erythema and inflammatory lesions—2 hallmark symptoms of rosacea. Here, Dermatology Times looks back at DFD-29’s journey to approval and its future role in the rosacea treatment landscape.

7. 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.

8. 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.

9. FDA Alerts Clinicians to Serious Complications with Radiofrequency Microneedling Devices

The FDA has issued a safety alert regarding radiofrequency (RF) microneedling devices used in aesthetic dermatology, highlighting reports of serious complications including burns, scarring, subcutaneous fat loss, nerve injury, and disfigurement. While most treatments are tolerated, risks increase with operator inexperience, aggressive treatment parameters, or use in sensitive areas. The agency emphasizes that RF microneedling is a medical procedure, not a cosmetic treatment, and encourages clinicians to carefully select patients, adhere to device-specific guidelines, and report adverse events via MedWatch. Patients are advised to seek treatment from licensed, trained providers and to be aware of potential risks. The FDA is investigating causes of complications and working with manufacturers to improve safety and post-market surveillance.

10. Guttman-Yassky Discusses APG777 as a Potential Breakthrough in AD

At the recent EADV Congress, Emma Guttman-Yassky, MD, PhD, discussed the investigational biologic APG777 (Apogee Therapeutics) and its potential in managing atopic dermatitis (AD). Targeting IL-13, a key cytokine in AD, APG777 may offer durable disease control with less frequent dosing than current biologics, improving patient adherence and reducing treatment burden. While early results are promising, further long-term studies are needed to confirm efficacy, safety, and optimal dosing. If validated, APG777 could become an important addition to AD treatment, offering both clinical benefit and practical advantages.