Oral and Topical Administration of a Standardized Saw Palmetto Oil Reduces Hair Fall and Improves the Hair Growth in Androgenetic Alopecia Subjects – A 16-Week Randomized, Placebo-Controlled Study

• Published in: Clinical, cosmetic and investigational dermatology Vol. 16; pp. 3251 - 3266
• Main Authors: Sudeep, Heggar Venkataramana, Rashmi, Sriram, Jestin, Thomas V, Richards, Aleksander, Gouthamchandra, Kuluvar, Shyamprasad, Kodimule
• Format: Journal Article
• Language: English
• Published: Dove Medical Press Limited 30.11.2023; Dove Medical Press
• Subjects: Alopecia; androgenetic alopecia; Baldness; Clinical trials; Fatty acids; hair loss; Hormones, Sex; Phytosterols; saw palmetto; Statistics; β-sitosterol; India
• ISSN: 1178-7015; 1178-7015
• DOI: 10.2147/CCID.S435795

Purpose: Androgenetic alopecia (AGA) is the most common type of hair loss in humans, affecting self-esteem and emotional wellbeing. This study aimed to assess the safety and efficacy of [VISPO.sup.TM], a standardized saw palmetto oil (2-3% [beta]- sitosterol), in subjects with mild-to-moderate AGA. Methods: In a double-blind, placebo-controlled, four-arm clinical study, 80 healthy male and female subjects aged 18-50 years were randomly allocated (1:1:1:1) to receive either 400 mg capsules of VISPO or 5 mL of a topical formulation containing 20% VISPO or the respective placebo once daily for 16 weeks. The primary endpoints included hair count (hair comb and hair pull tests) and the selfassessment of perceived efficacy. Objective evaluation was performed using the global photographic assessment score. Hair density, thickness, and anagen/telogen ratio were evaluated using phototrichogram analysis. Results: At the end of the study, oral and topical formulations of VISPO reduced hair fall by up to 29% (p<0.001) and 22.19% (p<0.01) from the baseline, respectively. Hair density increased by 5.17% and 7.61% in the oral and topical VISPO groups, respectively (p<0.001). In addition, oral ingestion of VISPO resulted in a marked reduction in serum dihydrotestosterone (DHT) levels in the subjects compared to placebo (p<0.001). However, the effect of the VISPO formulations on the anagen/telogen ratio was insignificant. No serious adverse effects were observed during the study. Conclusion: VISPO formulations reduced hair fall and promoted hair regrowth and scalp appearance in AGA patients. Keywords: hair loss, androgenetic alopecia, saw palmetto, P-sitosterol, fatty acids