Clascoterone 1% is effective for moderately severe acne (number needed to treat = 7 - 11)

Reference

Hebert A, Thiboutot D, Stein Gold L, et al. Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne two phase 3 randomized clinical trials. JAMA Dermatol 2020;156(6):621-630.

Synopsis

This is a report of two phase 3 trials of an anti-androgenic cream to treat acne vulgaris. A total of 1440 patients, 9 years and older, with moderate (83%) or severe (17%) acne were randomized to clascoterone 1% applied twice daily to the entire face for 12 weeks or matching vehicle cream. Patients with 2 or more nodules on their face were excluded. Patients could not use any other acne medications, either topical or systemic. Approximately 62% of the patients were female and 90% were white. Groups were balanced at baseline, and analysis was by intention to treat. The primary outcome was treatment success, defined as a 2-point reduction in the Investigator's Global Assessment score, which ranges from clear (0) to severe (4), and an overall assessment of clear (0) or almost clear (1). This primary outcome was achieved more often in the treatment group both in study 1 (18.4% vs 9.0%; P < .001; number needed to treat [NNT] = 11) and in study 2 (20.3% vs 6.5%; P < .001; NNT = 7). The cream was safe and well-tolerated. The studies were sponsored by the manufacturer and 4 of the co-authors were employed by the manufacturer. They are currently seeking FDA approval for clascoterone.