A multicenter, randomized, placebo-controlled, double-blind clinical trial of a novel formulation of 5% minoxidil topical foam versus placebo in the treatment of androgenetic alopecia in men.

Abstract

An alternative to currently marketed topical minoxidil solutions is desirable. To assess the efficacy and safety of a new 5% minoxidil topical formulation in a propylene glycol-free foam vehicle in men with androgenetic alopecia (AGA). This was a 16-week, double-blind, placebo-controlled trial of 5% minoxidil topical foam (MTF) in 352 men, 18 to 49 years old. At week 16, 143 subjects continued on an open-label phase to collect 52 weeks of safety information on 5% MTF. At week 16 compared with baseline, there was a statistically significant increase in (1) hair counts in the 5% MTF group versus placebo (P < .0001) and (2) subjective assessment of improved hair loss condition (P < .0001) in the 5% MTF group versus placebo. The 5% MTF was well tolerated over a 52-week period. There was no collection of efficacy data beyond 16 weeks. We believe that 5% MTF is a safe and effective treatment for men with AGA.