Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris

Abstract

Background: Androgens foster acnegenic pathways.

Objective: To assess the long-term safety of an androgen receptor inhibitor, clascoterone cream, 1%, in patients who participated in phase 3 studies.

Methods: Clascoterone cream was applied twice daily for up to 9 months to the face or trunk, or both. Treatment-emergent adverse events (TEAEs) and local skin reactions were evaluated at months 1, 3, 6, and 9, and at any unscheduled visit(s). The statistical analysis was performed using SAS Windows 9.3 software (SAS Institute Inc, Cary, NC).

Results: The study screened and enrolled 609 individuals (n = 317 clascoterone, n = 292 vehicle from original studies), and 347 completed the study (n = 179 clascoterone, n = 168 vehicle). Overall, 110 patients (18.1%) experienced 191 TEAEs. The most frequently reported TEAE was nasopharyngitis (n = 20). A total of 19 test article-related TEAEs occurred in 14 patients; of these, 9 experienced 9 TEAEs leading to discontinuation. There were 7 serious TEAEs in 6 individuals, but none were treatment related. One serious TEAE led to study discontinuation. Overall, treatment-emergent local skin reactions occurred in 18.1% (110 of 607). The most frequent local skin reactions on the face and trunk were erythema, scaling/dryness, and pruritus, and most were trace/minimal or mild in severity.

Limitations: Long-term efficacy was not a primary end point.

Conclusion: A low frequency of TEAEs over 9 months of clascoterone treatment was observed.

Keywords: acne; androgen receptor inhibitor; antiandrogen; clascoterone; cream; long-term safety; topical.