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.
| Autor: | Sudeep HV; Department of Biomedicinal Research, R&D Center for Excellence, Vidya Herbs Pvt Ltd, Bangalore, Karnataka, India., Rashmi S; BGS Global Institute of Medical Sciences, Bangalore, Karnataka, India., Jestin TV; Department of Clinical Research, Leads Clinical Research and Bio Services Private Ltd, Bangalore, Karnataka, India., Richards A; Department of Clinical Studies, R&D, Vidya Herbs, Red Bank New Jersey USA., Gouthamchandra K; Department of Biomedicinal Research, R&D Center for Excellence, Vidya Herbs Pvt Ltd, Bangalore, Karnataka, India., Shyamprasad K; Department of Biomedicinal Research, R&D Center for Excellence, Vidya Herbs Pvt Ltd, Bangalore, Karnataka, India. |
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| Jazyk: | angličtina |
| Zdroj: | Clinical, cosmetic and investigational dermatology [Clin Cosmet Investig Dermatol] 2023 Nov 11; Vol. 16, pp. 3251-3266. Date of Electronic Publication: 2023 Nov 11 (Print Publication: 2023). |
| DOI: | 10.2147/CCID.S435795 |
| Abstrakt: | 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 VISPO TM , 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. Competing Interests: 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. (© 2023 Sudeep et al.) |
| Databáze: | MEDLINE |
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