A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Women With Self-Perceived Thinning Hair openaccess articles

May 2018 | Volume 17 | Issue 5 | Original Article | 558 | Copyright © 2018

Glynis Ablon MD FAADa and Sophia Kogan MDb

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

Abstract

Hair loss is a complex problem that generates significant concern for those who are affected. Patients seeking medical treatments have limited options, and are increasingly turning to natural therapies. A novel nutraceutical product containing a proprietary Synergen Complex® composed of standardized, active botanicals with potent anti-inflammatory, adaptogenic (anti-stress), antioxidant, and dihydrotestosterone-inhibiting properties has been developed to improve hair growth and hair quality. The objective of this 6-month randomized, double-blind, placebo-controlled study was to assess the ability of this oral supplement (Nutrafol® Women’s Capsules) to strengthen and promote the growth of hair in adult women with self-perceived thinning. Enrolled subjects were randomized to receive active treatment (n=26) or placebo (n=14). The primary endpoint in this study was a statistically significant increase in the number of terminal and vellus hairs based on phototrichograms obtained through macrophotography analysis. Daily intake of the nutraceutical supplement resulted in a significant increase in the number of terminal and vellus hairs in the target area at day 90 and day 180 vs placebo (P less than 0.009). Blinded Investigator Global Hair Assessments revealed significant improvements in hair growth (P equals 0.016) and overall hair quality (P equals 0.005). A significant percentage of subjects receiving active treatment also reported improvement in hair growth, volume, thickness, and hair growth rate, as well as decreased anxiety and other wellness parameters. There were no reported adverse events. Conclusion: This nutraceutical supplement safely and effectively promoted hair growth in women with self-perceived thinning. It provides a multi-targeted therapeutic approach to hair loss by addressing micro-inflammation, stress, and oxidative damage with clinically tested, standardized, and bio-optimized phytoactive ingredients. ClinicalTrials.gov: NCT03206567 J Drugs Dermatol. 2018;17(5):558-565.

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INTRODUCTION

Hair loss is a chronic and progressive condition affecting at least 50% of women by age 50.1-4 The most common cause of hair loss, androgenetic alopecia (female pattern hair loss), affects at least 40% of women, and will progress without treatment.2,5 Effectively treating it is important because hair loss can have a significant psychological impact resulting in symptoms of depression3 and diminished quality of life, especially in women.6-8 Women of all ages can be affected and the presentation of thinning in women usually differs from men in that it is diffuse. Even sub-clinical hair thinning and increase in shedding may be an early stage in the gradual process of female pattern hair loss.9 Despite much research on the subject, the complex pathophysiology of hair loss in women is still not fully understood, which is reflected in the currently limited therapeutic options.Traditionally, alopecia has been sub-classified to reflect morphology and etiology, scarring vs non-scarring, hereditary vs acquired, and inflammatory vs non-inflammatory. As a result, the only available therapeutics were developed to address singular targets and mechanisms, such as the case with anti-androgen therapies (finasteride, spironolactone, etc) and vasodilator minoxidil.Unfortunately, many of these medications represent potential reproductive dangers10 and the quality of evidence supporting their use in women is generally poor.11 The application of topical minoxidil, which is the only US Food and Drug Administration (FDA)-approved drug for treatment of hair loss in women, is found to be difficult to incorporate into daily haircare routines. It may also cause growth of facial hair, as well as irritant or allergic dermatitis to vehicles in topical minoxidil preparations.12,13New research indicates however that hair loss is not the result of one singular pathway. Androgens are not the sole player in this much larger picture, and neither is simple nutritional

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