A Randomized, Double-Blind, Placebo-Controlled Study of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women With Thinning Hair

January 2021 | Volume 20 | Issue 1 | Original Article | 55 | Copyright © January 2021


Published online December 30, 2020

Glynis Ablon MD FAADa, Sophia Kogan MDb

aAblon Skin Institute and Research Center, Manhattan Beach, CA
bNutraceutical Wellness Inc., New York, NY

Abstract
Hair loss is a complex and multi-factorial problem that is associated with significant psychological morbidity in women. Menopausal women represent a significant percentage of those affected, since the menopausal hormonal transition can be a contributing factor. A novel nutraceutical supplement has been specifically formulated with phytoactives to improve hair growth and quality in menopausal women (Nutrafol® Women’s Balance Capsules).

The objective of this 6-month, randomized, double-blind, placebo-controlled study was to assess the safety and efficacy of this oral supplement to promote hair growth in perimenopausal, menopausal, and postmenopausal women with self-perceived thinning. Subjects were randomized to the study supplement (n=40) or placebo (n=30). The primary endpoint was a statistically significant increase in the number of terminal and vellus hairs based on phototrichogram analysis. Daily intake of the nutraceutical supplement resulted in progressive and significant increase in terminal and total hair counts on days 90 (P<0.01) and 180 (P<0.01) compared to placebo. The vellus hair counts significantly increased for the active treatment group (P<0.05) by day 180 while significantly decreasing for the placebo group subjects. Hair shedding progressively and significantly decreased for the active group compared to placebo, culminating in a reduction of 32.41% by day 180 (P<0.01). The study supplement was well-tolerated.

ClinicalTrials.gov Identifier: NCT04048031
J Drugs Dermatol. 20(1):55-61. doi:10.36849/JDD.2021.5701

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INTRODUCTION

Hair loss occurs in women almost as frequently as men, affecting at least 50% of women by age 50.1-5 A recent review on psychological and aesthetic impact of age-related hair changes in women showed hair loss to demonstrably affect a woman’s perceived age and psychosocial wellbeing.6 Increasing with age and menopause,7 the most commonly diagnosed alopecia is female pattern hair loss (FPHL), also known as androgenetic alopecia (AGA), which affects an estimated 40% of women over 60.8 The complex pathophysiology of FPHL is not yet fully elucidated, but is now considered to be only partly related to androgens, with growing evidence suggesting it’s multifactorial.9 Some attribute the increase in FPHL and generalized diffuse hair loss in postmenopausal women to normal physiological changes of menopause and aging.7,10 Hormonal changes in menopause include a rapid decline of ovarian estrogens and a relative increase in androgens.7,11

Consequently, hormonal changes of menopause are associated with decreased growth rate, percentage of hairs and time spent in anagen, a decrease in hair diameter and change in diameter distribution,11 as well as increased miniaturization.7,10 There are likewise age-related changes in hair diameter and density that are independent of menopause, but occur at approximately the same time, compounding the perception of hair loss for middle-aged women.6,11 Hair loss and thinning in women is polygenic and multi-factorial, with contribution from environmental factors such as aging, stress, and inflammation.4,6,9 Nevertheless, there is a paucity of controlled studies assessing interventions for hair thinning in menopausal women. Options are limited and have been developed to address singular targets, as exemplified by androgen-inhibiting therapies (eg, finasteride, spironolactone, etc), which are often used off-label for women after childbearing years.6,9 So far, results from studies on finasteride and spironolactone have been inconsistent, showing varied efficacy in post-menopausal women.6,9 Currently, the only FDA-approved drug for treatment of hair loss in women is topical minoxidil, which has potential side effects and many women find difficult to incorporate into daily haircare routines.5,12