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Clinical Trial
. 2023 Nov 11:16:3251-3266.
doi: 10.2147/CCID.S435795. eCollection 2023.

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

Heggar Venkataramana Sudeep  1 , Sriram Rashmi  2 , Thomas V Jestin  3 , Aleksander Richards  4 , Kuluvar Gouthamchandra  1 , Kodimule Shyamprasad  1
Affiliations
Clinical Trial

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

Heggar Venkataramana Sudeep et al. Clin Cosmet Investig Dermatol. .

Abstract

Purpose: Androgenetic alopecia (AGA) is the most common type of hair loss in humans, affecting self-esteem and emotional well-being. This study aimed to assess the safety and efficacy of VISPOTM, a standardized saw palmetto oil (2-3% β-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 self-assessment 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: androgenetic alopecia; fatty acids; hair loss; saw palmetto; β-sitosterol.

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Conflict of interest statement

The investigational product VISPOTM is a proprietary extract manufactured by Vidya Herbs Pvt., Ltd. Heggar Venkataramana Sudeep, Richards Aleksander, Kuluvar Gouthamchandra, and Kodimule Shyamprasad are employed by Vidya Herbs Pvt. Ltd., and Sriram Rashmi s employed by the BGS Global Institute of Medical Sciences, Bangalore, India. Thomas V. Jestin s employed by Leads Clinical Research and Bio Services Private Ltd. (Bangalore, India). The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Participant flow chart.
Figure 2
Figure 2
Effect of VISPO formulations on the changes in hair fall (count) from baseline to the end of study. (A) Hair comb test and (B) hair pull test. The data were analyzed by independent t-test. **p<0.01 and ***p<0.001.
Figure 3
Figure 3
Effect of VISPO formulations on changes in hair growth parameters – Phototrichogram analysis. (A) Hair density, (B) hair thickness and (C) anagen/telogen ratio. The data were analyzed by independent t-test. ***p<0.001.
Figure 4
Figure 4
Representative images showing the changes in scalp hair following 16-week treatment with oral/topical VISPO formulations. (A) Representative photographs showing the vertex region of the scalp. (B) Phototrichogram analysis performed at baseline and at 8 and 16 weeks.
Figure 5
Figure 5
Effect of VISPO formulations on the androgenic markers in serum. (A) 5α-reductase expression and (B) dihydrotestosterone (DHT) level. The data were analyzed by independent t-test. ***p<0.001.
See this image and copyright information in PMC

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