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

• Published in: Journal of the American Academy of Dermatology 2007-11, Vol.57 (5), p.767-774
• Main Authors: Olsen, Elise A., MD, Whiting, David, MD, Bergfeld, Wilma, MD, Miller, Jeffrey, MD, Hordinsky, Maria, MD, Wanser, Rita, BS, Zhang, Paul, PhD, Kohut, Bruce, DMD
• Format: Article
• Language: English
• Subjects: Administration, Topical; Adult; Alopecia - drug therapy; Alopecia - pathology; Biological and medical sciences; Dermatology; Double-Blind Method; Hair - pathology; Hair and nails disorders; Humans; Male; Medical sciences; Middle Aged; Minoxidil - administration & dosage; Minoxidil - adverse effects; Minoxidil - therapeutic use; Surveys and Questionnaires; Time Factors; Treatment Outcome
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2007.04.012

Background An alternative to currently marketed topical minoxidil solutions is desirable. Objective 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). Methods 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. Results 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. Limitations There was no collection of efficacy data beyond 16 weeks. Conclusions We believe that 5% MTF is a safe and effective treatment for men with AGA.