BACKGROUND:Hair loss remains 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 (Serenoa repens) for treating self-perceived thinning hair in healthy adult men and women (SEREVELLE, Valensa International; Eustis, FL). METHODS:This 6-month, randomized, double-blind, placebo-controlled study assessed the beneficial effects of daily active treatment (n = 40) vs. placebo (n = 20) on several hair growth parameters. RESULTS:Active treatment of SEREVELLE significantly outperformed placebo on all primary endpoints at Day 180. Mean (SD) change in baseline total terminal hair count was +18.6 (29.6) with active vs. -10.1 (30.5) with placebo (p < 0.001; 283% greater improvement). Total vellus hair count increased +6.6 (15.6) vs. -2.1 (15.7) (p < 0.05; 414% greater improvement). Total hair density rose +25.1 (27.7) vs. -12.2 (38.8) (p < 0.001; 306% greater improvement). Subgroup analyses at Day 180 corroborated these advantages: across populations, between-group differences in mean change favored active for subgroup of men, with total terminal hair count (p = 0.003), total vellus hair count (p < 0.001), and total hair density (p < 0.001). In menopausal women, active produced significant placebo-adjusted gains in total terminal hair count (p < 0.05) and total hair density (p < 0.01), with a nonsignificant numerical advantage for total vellus hair count. There were no treatment-related adverse events. CONCLUSION:The daily use of a proprietary saw palmetto (Serenoa repens) extract safely and effectively promotes hair growth in men and women with self-perceived thinning hair.
