OBJECTIVES: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged ≥12 years. Efficacy data from an open-label extension study are presented.

METHODS: The open-label, multicenter extension study (CB-03-01/27) enrolled male and female patients aged ≥9 years who completed one of the 12-week Phase 3 trials (CB-03-01/25 and CB-03-01/26) in patients with moderate-to-severe acne vulgaris. All patients applied 1% clascoterone cream twice daily to the face for 9 months; in the extension study, patients with truncal acne could also treat affected areas of the shoulders, chest, and/or back. Total time on clascoterone was up to 12 months for patients originally randomized to clascoterone in the Phase 3 trials. A 5-point Investigator’s Global Assessment (IGA; 0, clear; 4, severe) was performed at extension Days 29, 85, 183, and 274; clascoterone treatment could be discontinued if IGA was 0 or 1 (IGA 0/1) and reinstated if/when acne worsened. Efficacy was analyzed in the intention-to-treat (ITT) population.

RESULTS: The ITT population included 609 patients, of whom 251 patients were treated for truncal acne. At baseline/Day 29/85/183/274, the proportion of ITT patients achieving facial IGA 0/1 was 9.9%/8.5%/10.1%/17.3%/29.8% and the proportion of ITT patients achieving truncal IGA 0/1 was 4.8%/17.1%/20.7%/25.9%/31.5%. In the ITT population, 539/417/304/123 patients used clascoterone for a total of 3/6/9/12 months. By total time on clascoterone, 13.1%/18.9%/39.2%/56.1% of ITT patients achieved facial IGA 0/1 and 13.6%/37.6%/43.4%/59.2% of ITT patients achieved truncal IGA 0/1 after 3/6/9/12 months on clascoterone treatment.

CONCLUSIONS: Clascoterone cream 1% maintained a favorable efficacy profile for up to 12 months in patients aged ≥9 years with acne vulgaris.