The Safety and Efficacy of a Proprietary Bioactive Fatty Acids Extract From Saw Palmetto (Serenoa repens) for Promoting Hair Growth and Reducing Hair Loss in Adults With Self-Perceived Thinning Hair: 90-Day Results.

BACKGROUND: Hair loss is a global concern for both men and women. AIMS: This study assessed the efficacy and safety of a proprietary extract of bioactive fatty acids from saw palmetto for treating self-perceived thinning hair in healthy adult male and female subjects. METHODS: In this 6-month, randomized, double-blind, placebo-controlled study, subjects were randomized to receive active treatment (n = 40) or placebo (n = 20). Half of the enrolled subjects were female. Subjects took one oral dose of their assigned treatment daily. Assessments were performed at baseline, Day 56 and Day 90. Preliminary 90-day results are presented here. PATIENTS/METHODS: The active group showed significant improvement in terminal hair count from baseline in anterior (p < 0.0007) and posterior (p < 0.0005) areas. Compared to placebo, the improvement was also significant in the anterior (p < 0.05) and posterior (p < 0.03) areas. Anterior vellus hair count improved significantly versus baseline (p < 0.0005) and placebo (p < 0.01). Posterior vellus hair count showed significant within-group growth (p < 0.05). Total hair count was significantly greater than baseline for anterior (p < 0.001) and posterior (p < 0.0005) and significantly greater for anterior (p < 0.005) and posterior (p < 0.05) compared to placebo. Total terminal hair counts improved 7-fold, and total hair count improved 12-fold compared to placebo. A significant reduction in hair shedding was observed in the active group versus baseline (p < 0.05). No meaningful improvements were observed in the placebo group, and no adverse events were reported. CONCLUSION: These preliminary results indicate the daily administration of a proprietary saw palmetto (Serenoa repens) extract safely and effectively promotes hair growth in men and women with self-perceived thinning hair. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT06920758.