Open-Label, Long-Term Extension Study to Evaluate the Safety of Clascoterone (CB-03-01) Cream, 1% BID in Subjects with Acne Vulgaris.
Androgens foster acnegenic pathways.To assess the long-term safety of an androgen receptor inhibitor clascoterone cream, 1%, in subjects who participated in Phase 3 studies.Clascoterone cream was applied twice daily for up to nine months to the face and/or trunk. Treatment Emergent Adverse Events (TEAE) and Local Skin Reactions (LSR) were evaluated at Months 1, 3, 6, and 9, and at any unscheduled visit(s). All statistical analysis was performed using SAS®, Windows Version 9.3.There were 609 screened and enrolled subjects (n=317 clascoterone, n=292 vehicle from original studies); n=347 completed the study (n=179 clascoterone, n=168 vehicle). Overall, 110 (18.1%) subjects experienced 191 TEAEs. The most frequently reported TEAE was nasopharyngitis (n=20). Fourteen subjects had a total of 19 test article related TEAEs. Nine subjects experienced 9 TEAEs leading to discontinuation. Six subjects experienced seven serious TEAEs, none treatment related; one serious TEAE led to study discontinuation. Overall treatment emergent LSRs=18.1% (110/607). The most frequent LSRs on the face and trunk were erythema, scaling/dryness, and pruritus; most were trace/minimal or mild in severity.Long-term efficacy was not a primary endpoint CONCLUSIONS: A low frequency of TEAEs over 9-months of clascoterone treatment was observed.