The Safety and Efficacy of a Novel Saw Palmetto ( Serenoa repens ) Extract for Promoting Hair Growth in Adults With Self‐Perceived Thinning Hair: 180‐Day Results

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.