Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study

The study compared the efficacy and safety of once-daily 5% minoxidil topical foam (MTF) to twice-daily 2% minoxidil topical solution (MTS) in treating female pattern hair loss. In a randomized, phase III trial involving 322 women, the primary endpoint was the change in target area hair count (TAHC) at 24 weeks. Results showed that 5% MTF increased TAHC by 23.9 ± 2.1 hairs/cm², while 2% MTS increased TAHC by 24.2 ± 2.1 hairs/cm². The treatment difference was -0.3 hairs/cm², with a 95% confidence interval of -6.0 to 5.4, failing to meet the noninferiority criteria. Both treatments were well tolerated, but the noninferiority goal was not achieved.