A Phase III, Multicenter, Parallel-Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam Versus Vehicle in Women With Female Pattern Hair Loss

The study was a Phase III, randomized, double-blind, vehicle-controlled trial conducted at 17 international sites to evaluate the efficacy and safety of 5% minoxidil topical foam (MTF) in 404 women with female pattern hair loss (FPHL). Participants used either 5% MTF or vehicle foam once daily for 24 weeks. Results showed that 5% MTF significantly increased hair regrowth by 10.9 hairs/cm² at 12 weeks and 9.1 hairs/cm² at 24 weeks compared to the vehicle (P<.0001). Both subject self-assessment and expert panel review confirmed improved scalp coverage. Additionally, total unit area density (TUAD) increased significantly with 5% MTF. The treatment was well tolerated with minimal side effects. The study concluded that 5% MTF was effective and safe for promoting hair regrowth in women with FPHL.