Clascoterone Cream 1% is Safe and Effective for Papulopustular Rosacea: A Phase 2 Clinical Trial.

Abstract

Background: Papulopustular rosacea (PPR) is a chronic inflammatory facial dermatosis with a need for well-tolerated and effective topical therapies. Clascoterone cream 1% is an androgen receptor inhibitor and a promising novel treatment for PPR.

Methods: In this single-center, single-arm, phase 2 pilot study, adults with PPR applied clascoterone cream 1% twice daily to the face. The primary endpoint was biopsy-proven change in mean sebaceous gland number and diameter over 12 weeks. Secondary endpoints included Dermatology Life Quality Index (DLQI), patient-reported outcomes (PROs), and prevalence of adverse events.

Results: Twenty participants were enrolled, and 18 completed the study. Mean sebaceous gland count decreased significantly (4.94 ± 1.98 to 3.61 ± 2.33; P=0.012). Mean gland diameter also decreased, although not significantly (P=0.182). Mean DLQI scores significantly improved (7.5 ± 5.8 to 3.3 ± 5.6; P=0.029). PRO scores were favorable for papules/pustules (3.2 ± 1.1), facial redness (2.7 ± 1.0), general skin appearance (2.7 ± 1.1), and overall treatment satisfaction (3.1 ± 0.7). The treatment was well tolerated, with no serious adverse events. Mild, transient dryness (n=1) and eye irritation (n=1) resolved without intervention.

Conclusion: Clascoterone cream 1% demonstrated favorable tolerability, safety, and efficacy in PPR, with significant improvements in sebaceous gland count and patient-centered outcomes. These findings support the therapeutic potential of clascoterone cream 1% for the treatment of PPR.  .