A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Women With Self-Perceived Thinning Hair.
2018
: Hair loss is a complex problem that generates significant concern for those who are affected. Patients seeking medical treatments have limited options, and are increasingly turning to natural therapies. A novel nutraceutical product containing a proprietary Synergen Complex® composed of standardized, active botanicals with potent anti-inflammatory, adaptogenic (anti-stress), antioxidant, and dihydrotestosterone-inhibiting properties has been developed to improve hair growth and hair quality. The objective of this 6-month randomized, double-blind, placebo-controlled study was to assess the ability of this oral supplement (Nutrafol® Women's Capsules) to strengthen and promote the growth of hair in adult women with self-perceived thinning. Enrolled subjects were randomized to receive active treatment (n=26) or placebo (n=14). The primary endpoint in this study was a statistically significant increase in the number of terminal and vellus hairs based on phototrichograms obtained through macrophotography analysis. Daily intake of the nutraceutical supplement resulted in a significant increase in the number of terminal and vellus hairs in the target area at day 90 and day 180 vs placebo (P less than 0.009). Blinded Investigator Global Hair Assessments revealed significant improvements in hair growth (P equals 0.016) and overall hair quality (P equals 0.005). A significant percentage of subjects receiving active treatment also reported improvement in hair growth, volume, thickness, and hair growth rate, as well as decreased anxiety and other wellness parameters. There were no reported adverse events. CONCLUSION: This nutraceutical supplement safely and effectively promoted hair growth in women with self-perceived thinning. It provides a multi-targeted therapeutic approach to hair loss by addressing micro-inflammation, stress, and oxidative damage with clinically tested, standardized, and bio-optimized phytoactive ingredients. ClinicalTrials.gov: NCT03206567 J Drugs Dermatol. 2018;17(5):558-565.
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