Topical 2% Minoxidil Solution in Male Pattern Alopecia. The Initial European Experience

ABSTRACT: A double‐blind, 48‐week study was conducted to evaluate the safety and efficacy of topically applied 2% minoxidil solution in the treatment of male pattern baldness. Patients were randomly assigned to receive either 2% minoxidil solution or placebo for the first 24 weeks. After week 24, the placebo patients were crossed over to treatment with 2% minoxidil solution. Of the 428 patients enrolled in the study, 384 were evaluable at the end of the placebo‐controlled period, and 329 were evaluable at the end of the study. At the end of the placebo‐controlled period, the mean nonvellus hair count in the 2% minoxidil group was significantly higher than in the placebo group ( p = 0.0187). The mean increase in nonvellus hair in the 2% minoxidil group from baseline to week 24 was also significantly higher than in the placebo group ( p = 0.0385). From weeks 24 to 48, when both groups were on active drug, there was a statistically significant increase in the nonvellus hair count for both groups using within‐group analysis. The analysis of the patients'and investigators'assessment of hair growth showed significant differences in the distribution of responses between treatments at week 24. In both cases, it was believed that more hair growth