Clascoterone cream 1% phase 3 results presented at meeting.
The novel topical androgen receptor inhibitor clascoterone (Winlevi; Sun Pharma), gives dermatologists a new tool to combat acne vulgaris and data presented at the American Academy of Dermatology's 2022 Annual Meeting are demonstrating this product to be safe and effective in patients aged 12 and older.
Approved by the FDA in August of 2020, data from two multicenter phase 3 studies on this first-in-class topical were presented this week.
According to a press release from Sun Pharma about the findings, about 19% and 21% of the clascoterone-treated patients had an "investigator global assessment score (IGA) score of 0 or 1 with at least a 2-point reduction in IGA score from baseline," four months into the study, compared with about 9% and 7% of those in the placebo groups (P < 0.01) . Safety profiles were similar among the two groups, according to the release
Sun pharma presents phase 3 data for winlevi® (Clascoterone) cream 1% for the topical treatment of acne vulgaris at the aad annual meeting. Accessed March 30, 2022. https://www.prnewswire.com/news-releases/sun-pharma-presents-phase-3-data-for-winlevi-clascoterone-cream-1-for-the-topical-treatment-of-acne-vulgaris-at-the-aad-annual-meeting-301510376.html