A Novel Approach Against Male Pattern Hair Loss With Topical Dimethylglycine Sodium Salt (DMG-Na) and Caffeine: Efficacy of a 24-Week, Double-Blind, Randomized, Placebo-Controlled Trial.

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Background: Male pattern hair loss is the most common form of hair loss in men, occurring in specific patterns. Contributing factors include hormonal changes, stress, malnutrition, and insufficient blood microcirculation.Objective: Topical applied dimethylglycine sodium salt (DMG-Na) has been identified to increase skin microcirculation by activating endothelial nitric oxide synthase and inducing nitric oxide production. Given the importance of sufficient microcirculation on hair growth, the goal of this study was to evaluate the effectiveness of topically applied DMG-Na in combination with caffeine against male pattern hair loss.Methods: A 24-week, double-blind, randomized, placebo-controlled trial was conducted on 154 men with male pattern hair loss, treated with a DMG-Na and caffeine-containing shampoo or the corresponding placebo. The primary efficacy parameter was the change in the number of hairs pulled via hair pull test from baseline to 6 months of daily product application. Clinical efficacy was further evaluated via phototrichogram analysis on a subgroup of 30 subjects.Results: The decreased number of hairs pulled during the hair pull test after 6 months of active shampoo application was significantly higher compared to the placebo (-2.8 ± 1.6 vs. 0.6 ± 2.2; p < 0.001), with no reported adverse events. Phototrichogram results showed an increase in the number of hairs, hair density, and percentage of anagen hairs after 6 months of active shampoo usage (p < 0.001).Conclusion: The clinical efficacy of this novel DMG-Na and caffeine-containing shampoo demonstrates significant potential against male pattern hair loss, offering promising results without any undesirable side effects.