A new formulation of minoxidil (DC0120; Pierre-Fabre Dermatologie) with improved cosmetic characteristics is noninferior to a comparator minoxidil product (Alostil; Johnson & Johnson) for the stimulation of hair growth among men with androgenetic alopecia (AGA). Results from the phase 2, multicenter, randomized, placebo-controlled, double-blind study conducted at 4 sites in Germany were published in the Journal of Cosmetic Dermatology.
In each of the participants, 2 10-cm2 areas on the scalp were randomly assigned to receive DC0120, the comparator agent, or 1 of 2 corresponding vehicles, with each applied 2 times daily for 16 weeks. Measurements of nonvellus target area hair count (TAHC) within the treatment area were obtained at baseline and after 8 weeks and 16 weeks, by digital phototrichogram.
A total of 220 individuals with AGA were included in the analysis, with 210 completing the study. Overall, there were 110 patients in the DC0120 arm, 44 in the DC0120-comparator arm, 44 in the comparator-DC0120 vehicle arm, and 22 in the DC0120-vehicle comparator arm. The mean age of the participants was 41.5±10.9 years (range, 19 to 62 years).
Mean change in nonvellus TAHC between baseline and week 16 was +22.0 hairs/cm2 (95% CI, 18.1-25.9) in the DC0120 group vs +20.5 hairs/cm2 (95% CI, 16.6-24.4) in the comparator group. The adjusted mean difference in TAHC changes between the 2 therapies was +1.5 hairs/cm2 (95% CI, –2.3 to 5.2), with the lower 95% CI reported above the noninferiority threshold of –7 hairs/cm2.
The results of the study demonstrated that DC0120 was noninferior to the comparator agent. Compared with the vehicle groups, both minoxidil treatments increased nonvellus TAHC at 8 weeks and 16 weeks. No new safety concerns were revealed.
The investigators concluded that DC0120 is as efficacious and safe as a similar marketed minoxidil agent for the stimulation of hair growth among men with AGA. They do indicate, however, that because the products used in this study were applied to small treatment areas rather than to the entire scalp, the study was not of sufficient size to determine less common adverse events.
Blume-Peytavi U, Issiakhem Z, Gautier S, et al. Efficacy and safety of a new 5% minoxidil formulation in male androgenetic alopecia: a randomized, placebo-controlled, double-blind, noninferiority study [published online April 16, 2018]. J Cosmet Dermatol. doi: 10.1111/jocd.12541