Safety and Biopsy Outcomes of a Topical Treatment (SM04554) for Male Androgenetic Alopecia: Results from a Phase 2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Trial

A clinical trial evaluated the safety and efficacy of SM04554, a topical treatment for male androgenetic alopecia (AGA). The trial involved 49 males aged 18-65 who were treated daily for 90 days with 0.15%, 0.25% SM04554 or vehicle. The results showed that SM04554 was safe and well-tolerated, and increased follicle counts and hair bulb Ki-67 suggested that treatment with SM04554 may promote follicular neogenesis and potentially be efficacious for AGA.