A Long-Term Study of the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women

July 2022 | Volume 21 | Issue 7 | 783 | Copyright © July 2022


Published online June 30, 2022

Glynis Ablon MD FAADb, Sophia Kogan MDa, Isabelle Raymond PhDa

aNutraceutical Wellness LLC, New York, NY
bAblon Skin Institute and Research Center, Manhattan Beach, CA

Abstract
The prevalence of female hair loss and hair thinning increases with advancing age and is most common among post-menopausal women. Recent statistics show that by age 60, an estimated 80% of women experience hair loss. A previous publication detailing the results of the 6-month randomized, double-blind, placebo-controlled phase of this study demonstrated the ability of a nutraceutical supplement to significantly improve hair growth and shedding compared to placebo. Here, we present results from a subsequent 6-month, open-label extension phase assessing the continued safety and efficacy of this nutraceutical for promoting and improving hair growth and evaluate potential long-term benefits on quality of life and menopausal symptoms. After a total of 12 months with the active nutraceutical, subjects had progressive improvements in hair growth, quality, and shedding. Quality of life measures and menopausal symptoms also improved over the duration of the study. When transitioned to daily intake of the supplement, subjects previously treated with placebo achieved significant increases in all hair counts, a significant decrease in shedding, and significant improvement in blinded investigator global hair growth and quality assessments. The results of this long-term study demonstrate that continued use of a novel nutraceutical provides significant incremental improvement over the beneficial effects achieved during the initial 6-month randomized, placebo-controlled phase. Continued use may provide ongoing improvements in hair growth and exert a positive effect on secondary symptoms of menopause, and quality of life in perimenopausal, menopausal, and postmenopausal women with selfperceived thinning hair (ClinicalTrials.gov Identifier: NCT04048031).

J Drugs Dermatol. 2022;21(7):776-783. doi:10.36849/JDD.6912

INTRODUCTION

The prevalence of female hair loss and thinning increases with advancing age and is most common among post-menopausal women. Indeed, significant androgenetic hair loss occurs in perimenopausal, menopausal, and postmenopausal women, affecting at least 50% of women by age 50.1-5 The most recently published statistics show that by age 60, an estimated 80% of women experience hair loss.6 Due to its perceived effect on female attractiveness, hair loss can have a significant psychological impact on affected individuals, leading to low self-esteem,7 anxiety, and depression8,9 and generally diminished quality of life.9

The hormonal changes of menopause are associated with a decrease in hair diameter and change in diameter distribution, increased miniaturization,10,11 and decreased growth rate and time spent in the anagen phase.12 Additional age-related changes in hair diameter and density that are independent of menopause, tend to occur at approximately the same time, compounding the perception of hair loss for middle-aged women.12,13

Current therapies often target sole causes, while research shows the underlying pathophysiology of hair loss and thinning to be multifactorial, caused by intrinsic and extrinsic factors including stress, hormonal shifts, inflammation, environmental insults, oxidative stress, nutritional compromise, and the natural aging process.14 Treatment options are limited and mostly offlabel. Minoxidil, the only FDA-approved drug indicated for the treatment of hair thinning and loss in women has potential side effects, and many women find it difficult to incorporate into daily haircare routines.5,15 A nutraceutical formulation developed to provide a multi-targeted approach to thinning hair was evaluated in a randomized placebo-controlled study in women with self-perceived hair thinning.5 Results showed significant and progressive improvements in hair growth and hair quality at 3 and 6-months compared to placebo.