Efficacy and Safety of 1% Clascoterone Cream in Patients Aged ≥12 Years With Acne Vulgaris

Adelaide A. Hebert, Lawrence F. Eichenfield, Diane Thiboutot, Linda Stein Gold, Snejina Vassileva, Yanita Mihaylova, Martina Cartwright, Luigi Moro, Enrico Fragasso, Jenny Han, Nicholas Squittieri, Alessandro Mazzetti

Research output: Contribution to journalArticlepeer-review

2 Scopus citations


Background: Two randomized phase 3 studies evaluated efficacy and safety of 1% clascoterone cream, a topical androgen receptor inhibitor, in patients aged ≥9 years with moderate-to-severe facial acne vulgaris after 12 weeks of treatment. Objectives: To present a pooled data analysis of the efficacy and safety of 1% clascoterone cream after 12 weeks of treatment in patients aged ≥12 years from the 2 phase 3 trials. Methods: Patients were randomized 1:1 to twice-daily treatment of the whole face with clascoterone or vehicle. Primary efficacy outcomes were proportion of patients achieving treatment success (Investigator’s Global Assessment score of “clear” [0] or “almost clear” [1] with ≥2-point reduction from baseline) and absolute change from baseline (CFB) in noninflammatory lesion count and inflammatory lesion count; secondary efficacy outcomes included absolute CFB in total lesion count at week 12. Safety was assessed from treatment-emergent adverse events and local skin reactions. Results: 709/712 patients age ≥12 years were treated with clascoterone/vehicle. After 12 weeks, clascoterone was efficacious compared with vehicle, based on proportion of patients achieving treatment success (19.9% vs 7.7%) and CFB in noninflammatory lesion count (−20.8 vs −11.9), inflammatory lesion count (−19.7 vs −14.0), and total lesion count (−40.0 vs −26.1; all P<0.0001). Frequencies of local skin reactions were low and similar between treatment arms, with no new safety signals. Conclusions: Clascoterone is efficacious, with a favorable safety profile and low rates of local skin reactions in patients ≥12 years of age with facial acne vulgaris. (Clinicaltrials.gov

Original languageEnglish (US)
Pages (from-to)174-181
Number of pages8
JournalJournal of Drugs in Dermatology
Issue number2
StatePublished - Feb 2023

All Science Journal Classification (ASJC) codes

  • General Medicine


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