A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Efficacy of a Nutritional Supplement in Female Androgenic Alopecia

Abstract

Introduction. Androgenetic alopecia (AGA), the most common form of hair loss in women, is characterized by progressive hair thinning and loss of terminal hairs over frontal and parietal regions of the scalp. This study aimed to evaluate the efficacy of the nutritional supplement Pilopeptan® WOMAN 5αR (PPT5α) composed of specific plant extracts, vitamins, and minerals in women with initial to moderate AGA. Methods. This was a prospective, randomized, double-blind, placebo-controlled clinical trial study. Forty-seven women (aged 25–59 years) with AGA grade I/II were randomized to daily receive PPT5α (n = 24) or placebo (n = 23), and the treatment safety, as well as the percentages of terminal hair in frontal and parietal areas from trichoscopic images, was assessed at 0, 3, and 6 months. Secondary outcomes included self-assessed hair parameters and overall treatment satisfaction. Results. A total of 44 women completed the study. At 6 months, patients who received the nutritional supplement showed high percentages of terminal hair both in the frontal (77.6% vs 69.8%, $p=0.02$ ) and parietal (77% vs 64.3%, $p=0.02$ ) areas compared to the placebo group. Self-assessed evaluation of hair parameters showed an improvement in the reduction of hair loss and hair thickness both at the 3-month ( $p=0.004$ and $p=0.012$ ) and 6-month ( $p=0.009$ and $p=0.004$ ) visits. At the 3 month visit, the intervention group also showed higher treatment satisfaction $\left(p=0.01\right)$ . No significant adverse events were reported. Conclusion. These results evidence that the nutritional supplement PPT5α may be beneficial in preventing progression or even improving the condition of AGA in the early stages.