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This is a Pre-Registered Trial study.

December 4, 2025Open Access

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

Key Points

The active group in the clinical trial showed significant improvement in terminal hair count and reduced hair shedding.
Compared to placebo, the placebo-controlled study revealed marked enhancements in hair counts and growth areas at Day 90.
Randomized double-blind methodology was employed in this assessment of a proprietary extract for hair loss treatment.
Improved safety and efficacy might offer a promising solution for individuals experiencing hair loss.

Abstract

ABSTRACT 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

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