Sam480 Posted 11 hours ago Author Report Posted 11 hours ago https://www.cosmopharma.com/news/cosmo-announces-breakthrough-phase-iii-topline-results-from-scalp-1-and-scalp-2-for-clascoterone-5-solution-in-male-hair-loss-showing-up-to-539-relative-improvement-in-target-area-hair-count-vs-place Cosmo announces breakthrough Phase III Topline results from Scalp 1 and Scalp 2 for Clascoterone 5% Solution in male hair loss, showing up to 539% relative improvement in Target-Area Hair Count vs placebo; US and EU submissions are underway Ad hoc announcement pursuant to Art. 53 LR 1,465 patients were randomized into the two identical-in-design clinical studies Scalp 1 (NCT05910450) and Scalp 2 (NCT05914805) Both studies reached statistically significant endpoints in TAHC (Target-Area Hair Count), with one reaching 539% relative improvement to placebo and the second study reaching 168% relative improvement to placebo Positive safety profile demonstrated across both studies Positive safety profile demonstrated across both studie Largest Phase III program ever conducted for a Topical Treatment for Male Androgenetic Alopecia (AGA) First novel mechanism of action and first potential innovation in over 30 years in male hair loss Preparations are underway for parallel regulatory submissions in the United States and Europe Quote
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