The German Double‐Blind Placebo‐Controlled Evaluation of Topical Minoxidil Solution in the Treatment of Early Male Pattern Baldness

ABSTRACT: A double‐blind, 24‐week, placebo‐controlled study was conducted in Germany to evaluate the safety and efficacy of topically applied 2% minoxidil solution in the treatment of male pattern baldness. One hundred sixty‐three patients were evaluable, and applied 1 ml of either the placebo or 2% minoxidil solution twice daily throughout the study. The 2% minoxidil solution was significantly superior to placebo in all primary efficacy parameters (nonvellus hair count, and investigator and patient subjective evaluations of hair regrowth). One patient in each group discontinued treatment after developing scalp dermatitis: both cases were considered to be related to the treatment. No significant changes were observed in vital signs or laboratory parameters. Topical minoxidil 2%solution is safe, and is a more effective treatment than placebo for early male pattern baldness.