Dermata Therapeutics Inc (Nasdaq: DRMA, DRMAW), a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin diseases and conditions, announced on Tuesday that the last patient has completed their last visit in the company's first pivotal Phase 3 Spongilla Treatment for Acne Research (STAR-1) trial of XYNGARI, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne.
Topline data from the study will be announced by the end of March 2025.
The Phase 3 STAR-1 clinical study is intended to assess the efficacy, safety and tolerability of XYNGARI in patients with moderate-to-severe facial acne. It was a randomised (2:1), double-blind and placebo-controlled study that enrolled 520 patients with moderate-to-severe acne, ages nine years and older in the United States and Latin America.
Primary endpoints include the mean change from baseline in inflammatory and noninflammatory lesion counts and the Investigator Global Assessment (IGA) treatment response.
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