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Randomized Controlled Trial
. 2025 Jan;24(1):e16778.
doi: 10.1111/jocd.16778.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Nutraceutical Supplement With Standardized Botanicals in Males With Thinning Hair

Neal Bhatia  1 , Glynis Ablon  2 , Patricia K Farris  3 , Adina Hazan  4 , Isabelle Raymond  4
Affiliations
Randomized Controlled Trial

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Nutraceutical Supplement With Standardized Botanicals in Males With Thinning Hair

Neal Bhatia et al. J Cosmet Dermatol. 2025 Jan.

Abstract

Background: Hair thinning in men is a prevalent issue for which treatment oftentimes consists of a multi-modal approach. Targeting key root causes of hair thinning, such as hormones, stress, and metabolism through vitamins, minerals, and botanicals, has been shown to be effective in improving hair growth and quality in women. This approach could also be effective in improving hair growth and quality in men with thinning hair.

Aims: This study investigates the safety and efficacy of a nutraceutical in improving hair growth and quality in men with thinning hair.

Methods: This was a 6-month multi-center, double-blind, randomized, placebo-controlled trial. Men aged 21-61 years old with confirmed hair thinning were included. Subjects were randomized to receive the oral supplement or placebo. The study end points included changes in blinded Global Investigator Ratings for hair growth and quality, the Men's Hair Growth Questionnaire (MHGQ), and changes in the Arizona Sexual Experience Scale (ASEX) in the active group compared to baseline and placebo.

Results: Daily intake of the nutraceutical resulted in significantly more subjects in the active group compared to the placebo rated as improved for hair growth and quality in the blinded investigator global assessments. Overall changes and responses to the MHGQ also corroborated blinded investigator ratings. There were no trends in either treatment group for changes in sexual function on the ASEX questionnaire, and the supplement was well tolerated.

Conclusions: Ingestion of a nutraceutical targeting key root causes of male hair thinning significantly improves hair growth and quality in men with no changes in sexual function.

Keywords: MPHL; botanicals; hair thinning; male pattern hair loss; nutraceutical; supplement.

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Conflict of interest statement

Dr. Neal Bhatia is an advisor for Nutrafol and has received research grants from Nutraceutical Wellness Inc. Dr. Glynis Ablon has previously received research grants from Nutraceutical Wellness Inc. Dr. Patricia K. Farris is an advisor for Nutrafol and Nutraceutical Wellness Inc. Drs. Adina Hazan and Isabelle Raymond are employees of Nutraceutical Wellness Inc.

Figures

FIGURE 1
FIGURE 1
Improvements in hair growth and quality at Day 180 by blinded investigator global assessment. Bar graph showing percent of subjects rated as improved, no change, or worsened in (A) growth and (B) quality. (C) Representative subjects of different Norwood–Hamilton (NH) levels showing improvement in scalp coverage in the active subjects but not in the placebo subjects. *p < 0.05; **p < 0.01 compared to placebo.
FIGURE 2
FIGURE 2
Subject responses to the Men's Hair Growth Questionnaire (MHGQ) at Day 180. (A) Percentage of subjects in active and placebo groups responding positively to each question in the MHGQ. (B) Percentage of subjects in active and placebo groups responding negatively to each question in the MHGQ. (C) Difference in responses between active and placebo groups in MHGQ. Bars indicating positive responses (light teal) in positive direction indicate that the active group agreed more than the placebo group. Bars indicating negative responses (dark teal) in the negative direction indicate that the placebo group disagreed more than the active group. *p < 0.05; **p < 0.01; ***p < 0.0005 compared to placebo.
See this image and copyright information in PMC

References

    1. American Hair Loss Association , “Men's Hair Loss,” 2024, accessed August 27, 2024, https://www.americanhairloss.org/mens‐hair‐loss/.
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    1. Farris P. K., Rogers N., McMichael A., and Kogan S., “A Novel Multi‐Targeting Approach to Treating Hair Loss, Using Standardized Nutraceuticals,” Journal of Drugs in Dermatology 16, no. 11 (2017): s141–s148. - PubMed
    1. Stephens T. J., Berkowitz S., Marshall T., Kogan S., and Raymond I., “A Prospective Six‐Month Single‐Blind Study Evaluating Changes in Hair Growth and Quality Using a Nutraceutical Supplement in Men and Women of Diverse Ethnicities,” Journal of Clinical and Aesthetic Dermatology 15, no. 1 (2022): 21–26. - PMC - PubMed

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