A 48-week, double-blind, randomized study was conducted in France, West Germany and the UK to compare the safety and efficacy of topical minoxidil 2% (Regaine; registered trade mark of the Upjohn Company) solution with placebo in the treatment of early male-pattern baldness. At week 24, the end of the placebo period, there were 225 evaluable patients, 116 in the treatment group and 109 in the placebo group. The 2% minoxidil group showed superiority to the placebo group with respect to the following parameters at week 24: (1) non-vellus hair counts (p = 0.0084); (2) changes in non-vellus hair counts compared with baseline values (p = 0.0227), and (3) investigators' evaluations of hair growth (p = 0.019). There was no significant difference between minoxidil and placebo treatment with regard to blood pressure, pulse or weight changes. No serious side effects were reported during the study. The greatest number of medical events were dermatological in nature and mainly local and mild in intensity. From week 24 to week 48 all patients received active medication and showed further hair growth. At week 48 the investigators evaluated the new hair growth as moderate or dense in 32.7% of the patients. Our conclusion confirms previous reported studies according to which topical minoxidil seems to offer a safe and efficacious treatment for early male-pattern baldness in some patients. Further studies need to be done to characterize the most likely responders.