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

Journal of the American Academy of Dermatology Apr 29, 2020

Eichenfield L, Hebert A, Gold LS, et al. - Researchers conducted the study for analyzing the long-term safety of an androgen receptor inhibitor clascoterone cream, 1%, in patients with acne vulgaris who took part in Phase 3 studies. Clascoterone cream was applied twice daily to the face and/or trunk for up to nine months. Treatment emergent adverse events (TEAE) and local skin reactions (LSR) were assessed at 1, 3, 6, and 9 months and at any unscheduled visit(s). Using SAS®, Windows Version 9.3, all statistical analysis was performed. There were 609 participants screened and enrolled (n = 317 clascoterone, n = 292 vehicle from original studies); n = 347 completed the study (n = 179 clascoterone, n = 168 vehicle). Overall, there were 191 TEAEs in 110 (18.1%) patients. Nasopharyngitis was the most frequently reported TEAE. Erythema, scaling/dryness, and pruritus were the most frequent LSRs on the face and trunk; most were trace/minimal or mild in severity. A low frequency of TEAEs over 9-months of clascoterone treatment has been noted.

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