OBJECTIVES: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged ≥12 years. Pooled efficacy and safety data stratified by age and sex from two randomized, double-blind, vehicle-controlled Phase 3 studies (CB-03-01/25 and CB-03-01/26) and an open-label long-term extension study (CB-03-01/27) are presented.

METHODS: Patients with moderate-to-severe acne were randomized 1:1 to twice-daily treatment of the face with clascoterone or vehicle for 12 weeks (W); all patients continuing into the open-label extension study applied clascoterone for up to 9 additional months. Efficacy was assessed in the intention-to-treat (ITT) population for proportion of randomized patients achieving an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) with a ≥2-point reduction from baseline. Safety was assessed from treatment-emergent adverse events (TEAEs) in all treated patients.

RESULTS: Of 709/712 patients aged ≥12 years originally randomized to clascoterone/vehicle, 63.9%/60.4% were female, and the mean ± standard deviation (SD) age was 19.8 ± 6.1/19.5 ± 6.1 years; there were only 11/13 male patients aged ≥25 years, and no data are shown for this subgroup. Among patients in the ITT population randomized to clascoterone/vehicle, 17.2%/3.9% (12–17 years; P <0.0001), 24.4%/9.8% (≥18 years; P <0.0001), and 31.5%/10.8% (females ≥25 years; P = 0.002) achieved IGA 0/1 by W12; 45.6%, 54.0%, and 44.4% of extension study patients aged 12–17, ≥18, and females ≥25 years, respectively, achieved IGA 0/1 after 12 months applying clascoterone. Frequency of TEAEs through W12 in clascoterone/vehicle-treated patients was 10.8%/14.2%, 11.5%/11.6%, and 9.6%/12.9% for ages 12–17, ≥18, and females ≥25 years, respectively.

CONCLUSIONS: Clascoterone efficacy and safety were maintained in adolescent and adult patients, including female patients aged ≥25 years.