Comparison of a New 5% Minoxidil Foam and Rogaine® in the Treatment of Androgenetic Alopecia in Chinese Men: A Randomized, Double-Blind, Phase III, Equivalence Trial

Abstract

Androgenetic alopecia (AGA) is a common cause of hair loss in adults. We aimed to compare the efficacy and safety of topical generic 5% new minoxidil foam (NMF) versus 5% minoxidil Rogaine® foam in male patients with AGA. A randomized, double-blind, controlled, phase III, equivalence trial in 10 centers in China between December 25, 2019, and June 28, 2021, was performed. In total, 417 men patients (≥18 years) with AGA were randomized to receive 5% NMF (211 patients) or 5% Rogaine® foam (206 patients) 1 g two times daily for 24 weeks. The primary outcome was the changes in nonvellus target area hair counts (TAHC) from baseline to week 24. Equivalence was concluded if the 95% confidence interval (CI) for the treatment difference between the 5% NMF and Rogaine® groups was within (−8.00, 8.00). After 24 weeks of treatment, the mean difference in the change of nonvellus TAHC between the 5% NMF group and the Rogaine® group was −3.85 ± 1.62 hair/cm2 in full-analysis set (FAS) and −3.96 ± 1.68 hair/cm2 in per-protocol set (PPS), and the 95% CI of mean difference was (−7.03, −0.67) in FAS and (−7.26, −0.66) in PPS. No significant differences were found between the two groups in hair diameter, the ratio of terminal hair to vellus hair, the global photographic assessment by investigators, and adverse events (all P > 0.05). 5% NMF is as effective as Rogaine® in increasing hair density and hair diameter in AGA patients and was found to be safe. This trial is registered with CTR20191708.