A Prospective, Multi-Center Study to Evaluate the Safety and Efficacy of a Vegan Nutraceutical to Improve Hair Growth and Quality in Females Following a Plant-Based Diet

August 2024 | Volume 23 | Issue 8 | 661 | Copyright © August 2024


doi:10.36849/JDD.8421

Raja K. Sivamani MD MS APa-d, Glynis Ablon MD FAADe,f, Yvonne Nong MDb, Jessica Maloh NDb, Adina Hazan PhDg, Isabelle Raymond PhDg

aPacific Skin Institute, Sacramento, CA
bIntegrative Skin Science and Research, Sacramento, CA
cDepartment of Dermatology, University of California-Davis, Sacramento, CA
dCollege of Medicine, California Northstate University, Elk Grove, CA
eAblon Skin Institute & Research Center, Manhattan Beach, CA
fDepartment of Dermatology, University of California Los Angeles (UCLA), Los Angeles, CA
gNutraceutical Wellness LLC, New York, NY

Abstract
Hair thinning affects upwards of 50% of women by age 50, impacting their social-emotional wellbeing. It is a condition now thought to be driven by a multi-factorial etiology, including diet and nutrition. Women following vegan, vegetarian, or other plant-based diets have specific needs for nutrients traditionally sourced from animals, which could affect hair health. To support hair growth and quality in women following a plant-based diet, a novel vegan nutraceutical (Nutrafol Women's Vegan Capsules, Nutraceutical Wellness, Inc., New York, NY) was evaluated for its ability to support hair health. The objectives of this 6-month, multi-site, single-blind prospective clinical study was to evaluate the safety and efficacy of the nutraceutical to improve hair growth and quality in women consuming a plant-based diet. The primary endpoint in this study was an increase in terminal hair count at day 180 compared with baseline, as assessed through phototrichogram analysis. Ninety-five subjects completed the study. Daily intake of the nutraceutical resulted in a significant increase in the number of terminal hairs at day 90 (P<0.01) and day 180 (P<0.01). There was also an increase in total hair counts (P<0.01), the terminal-to-vellus ratio (P<0.01), and a decrease in shedding (P<0.01). Global Investigator Ratings revealed improved hair growth (P<0.00001) and overall quality (P<0.00001). In-person hair strength and brittleness assessments significantly improved as well (P<0.01 for both). A significant proportion of subjects reported improved hair quality, appearance, texture, and volume. Hair problems affecting the quality of life of the subjects were also reported as improved. This study demonstrated significant improvements in hair growth and quality in a plant-based population with a vegan nutraceutical.

ClinicalTrials.gov Identifier: NCT05332743.

J Drugs Dermatol. 2024;23(8):661-668.  doi:10.36849/JDD.8421

INTRODUCTION

Hair loss and thinning are common conditions affecting both men and women that are more recently recognized to be the result of multiple causes.1 Hair loss can have a significant, detrimental impact on self-esteem, psychosocial functioning, and the overall quality of life of affected individuals.2,3 It can also present a substantial financial burden on individuals seeking treatment.4

There are few United States Food and Drug Administration (FDA)-approved medical treatment options for women.4 Conventional options include FDA-approved topical minoxidil, but most women are treated with off-label medications including spironolactone, 5-alpha reductase inhibitors such as finasteride or dutasteride, and, more recently, low dose oral minoxidil.4 While these medications are effective for thinning hair, they may either have low adherence rates due to effects on hair texture and styling or be associated with side effects.4,5 In-office procedures including Platelet-Rich Plasma (PRP) therapy and devices like Low-Level Laser therapy are also common practice, though patients are increasingly turning to more accessible, over-the-counter solutions for thinning hair, including natural therapies and dietary supplements.4,5
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