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


Glynis Ablon MD FAAD,a Sophia Kogan MDb

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

During each clinic visit, 2-dimensional standardized global photographs (7 views) were obtained of the entire head, hair and target region (IntelliStudio®, Canfield Scientific; Parsippany, NJ). Two-dimensional images were used for informational purposes and to assist in grading general hair growth and hair quality assessments. At day 90 and day 180 visits, the blinded investigator completed assessment of Global Hair Growth and Global Hair Quality Improvement (texture, shine, dryness, scalp coverage, hair brittleness, and overall appearance) from baseline. Scoring was based on a 7-point scale with a range of -3 = greatly worsened to +3 = significantly improved.

The Women’s Hair Loss Quality of Life Questionnaire,13 QOL Subject Hair Satisfaction Questionnaire, and Menopause Rating Scale Questionnaire14 self-assessments were administered at all visits, while Self-Assessment Questionnaire, Subject Treatment Satisfaction, and Ease of Use Questionnaire at 3 and 6 months.

Study Endpoints
The primary efficacy endpoint from phototrichogram analyses was the change in the number of terminal, vellus, and total hairs at day 90 and day 180. Secondary endpoints were change in hair shedding counts, change in blinded physician global hair assessments for hair growth and quality, and responses on subject self-assessments.

Statistical Analysis
Descriptive analyses initially examined the distribution and characteristics of variables to summarize the study population. Continuous measures were evaluated across visits and comparing treatment groups using parametric Analysis of Variance (ANOVA) test. Categorical measures were evaluated descriptively and using the non-parametric Fisher’s exact test.

All analyses were two-tailed, where applicable, with P-value of <0.05. Analyses were performed using a commercial statistical package (GraphPad Prism 8.4.3. San Diego, CA. Released 2020).

RESULTS

Subject Demographics and Baseline Characteristics
Seventy female subjects were enrolled and randomized to receive active treatment (n=40) or placebo (n=30). The interim analysis is based on 60 (33 active and 27 placebo) per protocol population who completed the 6-month randomized phase of the study. Subjects had an overall mean age of 55.2 (6.6 SD) years with no significant differences between groups. Demographics and baseline characteristics are summarized in Table 1. Most subjects were post-menopausal (58%) with about one-half (47%) experiencing menopause symptoms, which was comparable between active (48%) and placebo groups (44%). The two most frequently reported menopause symptoms were hot flashes (61%) and irregular menses (43%) (Table 2). Most subjects reported symptom frequency as sporadic but a few experienced symptoms as often as 4–5 times weekly. Subjects reporting hot flashes indicated they tend to occur daily. Among subjects receiving thyroid medication (n=14), most were randomized to the active treatment group (n=12); however, a sub-analysis of covariance performed on the total hair count data determined this difference in thyroid medication had no impact on the primary endpoint.

Primary Endpoints
Among subjects in the active treatment group, terminal hair counts (Figure 1) and total hair counts (Figure 2) progressively and significantly increased on days 90 (P<0.01) and 180 (P<0.01) compared to placebo. The increase in terminal hair counts translated into a significant improvement of 4.3% by day 90 and 10.2% by day 180 from baseline for the active treatment group vs a negligible change of -0.2% and 0.7%, respectively, for the placebo group. Total hair count improvements translated into