The clinical assessments for day 180, 270, and 360 evaluations were the same as those for the first 6 months, and included terminal, vellus, and total hair counts of a pre-specified target area on the scalp based on phototrichogram analysis via macrophotography (Canon Power Shot® G16 with 3GEN Dermlite FOTO Pro Dermoscopy DSRL lens), shed hair counts and standardized 2-dimensional global digital images (IntelliStudio®, Canfield Scientific; Parsippany, NJ). The blinded investigator completed Global Hair Growth and Global Hair Quality Improvement assessments. Subjects completed a Hair Satisfaction and Hair Quality Questionnaire, the Women’s Hair Loss Quality of Life Questionnaire17, and the Menopause Rating Scale Questionnaire18 at each time point.
Comparative Analysis
The open-label extension phase first made comparative analyses of subjects who received active treatment during both study phases for the entire 12-month duration of the study. Comparisons were made at all timelines on days 90, 180, 270, and 360 vs baseline (day 0). The second comparative analyses were made for the group of subjects initially taking placebo. Comparisons were made between the first 6 months of those subjects taking placebo (Phase I: day 0, 90, 180) and the extension phase when the same subjects were taking the active nutraceutical (Phase II: day 180, 270, 360).
ANOVA for independent samples was used to compare demographics and baseline characteristics of each group, Tukey analysis was used to determine differences across time points and Student’s t-tests was used for correlated samples to compare hair counts. A series of Chi-Square tests were performed to determine the significance of the Investigator Global Improvement and Subject Satisfaction assessments. All analyses were 2-tailed, where applicable, with α=0.05. Analyses were performed using a commercial statistical package (GraphPad Prism 8.4.3. San Diego, CA., Released 2020).
RESULTS
All 60 subjects completed the study per protocol through day 360 and completed the day 270 questionnaires; however, live assessments at day 270 could not be performed due to restrictions imposed by the COVID-19 pandemic, so only subjective assessments were collected virtually. Subjects in the active treatment group (n=33) and placebo group (n=27) had mean (SD) ages of 48.3 (10.5) years and 53.14 (5.7) years, respectively. There were no significant differences in subject age or other demographic or clinical characteristics across groups. There were no significant between-group differences in the quantity of alcohol consumed, diet, exercise, or stress, or any other parameters, except for a greater number of subjects taking thyroid medications among subjects in the active treatment group (n=12, 36%) vs. placebo subjects (n=2, 7%); however, a sub-analysis of covariance determined this difference had no impact on the primary endpoint.
A similar number of subjects reported menopausal symptoms in the active supplement (n=15, 48%) and placebo groups (n=12, 44%). Subjects in the active supplement group reported they were perimenopausal (n=7, 24%), menopausal (n=8, 24%) or post-menopausal (n=17, 51%) while subjects in the placebo group were perimenopausal (n=6, 22%), menopausal (n=3, 11%) or post-menopausal (n=18, 67%).
Hair Counts and Global Assessments
Changes Over 12-months of Taking the Active Nutraceutical
Among subjects who received the active supplement for 12
A similar number of subjects reported menopausal symptoms in the active supplement (n=15, 48%) and placebo groups (n=12, 44%). Subjects in the active supplement group reported they were perimenopausal (n=7, 24%), menopausal (n=8, 24%) or post-menopausal (n=17, 51%) while subjects in the placebo group were perimenopausal (n=6, 22%), menopausal (n=3, 11%) or post-menopausal (n=18, 67%).
Hair Counts and Global Assessments
Changes Over 12-months of Taking the Active Nutraceutical
Among subjects who received the active supplement for 12
