Efficacy of an Oral Supplement in Women with Self-Perceived Thinning Hair: Results from a 6-Month Double-Blind, Placebo-Controlled Clinical Study
Glynis Ablon, MD, FAAD, Ablon Skin Institute Research Center, Manhattan Beach, CA
BACKGROUND
An oral food supplement has been developed to promote existing hair growth for women suffering from temporary thinning hair (Viviscal®
Hair Nourishment System; Lifes2good,
Inc., Chicago, IL). The following double-blind, placebo controlled study was designed to assess the ability of Viviscal to promote hair growth when administered daily to women with self-perceived thinning hair over a 6-month period.
SUBJECTS The study enrolled 15 women that were 21-75 years old with Fitzpatrick I-IV photo skin types. All subjects were in generally good health but had self-perceived thinning hair associated with poor diet, stress, abnormal menstrual cycle or other hormonal influences. The enrolled subjects agreed to maintain their present lifestyle including their current diet, medications, and exercise routines during the study and expressed their willingness to maintain a consistent hair cut, hair color and hair shampooing frequency throughout the 6- month study period. Women of child-bearing potential agreed to use a medically approved form of birth control during the study.
PROCEDURES Enrolled subjects were evaluated at baseline and after 90 ±7 days and 180 ±7 days of treatment. The Investigator selected an approximately 4 cm2
area of scalp at the junction of the
frontal and lateral hairlines for assessment. This area was identified using a 3-point system of measurements from the medial canthus, lateral canthus, and preauricular skin pit. This area of scalp was photographed using a digital camera.
Other assessments included a physical examination, scalp examination, and vital signs. Women of childbearing potential were required to provide a negative urine pregnancy test. Enrolled subjects were then randomized to undergo treatment with Viviscal (N=10) or placebo (N=5) in double-blind fashion. Subjects were instructed to take one tablet each morning and evening with water following a meal.
EFFICACY MEASURES Hair counts in the target area were performed at each clinic visit. The primary measure of efficacy was the change in the number of terminal and vellus hairs in each target area. A secondary measure of efficacy was the change in responses to a subject Self-Assessment Questionnaire.
SAFETY MEASURES
At each clinic visit, subjects underwent a brief physical exam including vital signs and were questioned about any possible adverse events.
STATISTICAL ANALYSIS The primary endpoint measures obtained at each evaluation were compared to baseline using a paired t-test. Comparisons between Viviscal and placebo treatments were made using ANOVA. Secondary endpoint parameters were compared using top-box analysis. Differences were considered significant at the level of p≤0.05.
ETHICS This protocol was approved by a local Institutional Review Board and each subject provided signed informed consent and photographic release forms prior to participating in study- related activities. This study was performed in accordance with the guidelines for the protection of human research subjects as described in 21 CFR Part 50 and according to the standards for Good Clinical Practices and the practice standards of Ablon Skin Institute Research Center.
RESULTS
The mean (SD) age of the women in the Viviscal and placebo treatment groups were 49.9 (8.5) and 47.6 (17.0) years, respectively, and were not significantly different. All subjects were Caucasian and one subject claimed Hispanic ethnicity.
At baseline, the mean number of terminal hairs among placebo-treated subjects was 256.0 (24.1) and remained at 245.0 (22.4) and 242.2 (26.9) after 90 and 180 days, respectively (Table 1). In contrast, the mean number of terminal hairs in the Viviscal-treated subjects was 271.0 (24.2) at baseline, increasing to 571 (65.7) and 609.6 (66.6) after 90 and 180 days, respectively (for each, p < 0.001 vs. placebo) (Figure 1). The mean number of vellus hairs among placebo- treated subjects was 57.0 (32.1) at baseline and 68.0 (21.4) and 65.8 (16.6) after 90 and 180 days, respectively. The mean number of vellus hairs among Viviscal-treated subjects was 46.5 (17.7) at baseline and 48.0 (16.2) and 46.5 (14.4) after 90 and 180 days, respectively. The change in hair growth following 180 days of treatment is evident in two patients shown in Figures 2 and 3.
Compared to placebo, the subjects treated with Viviscal for 90 days reported significant improvements in several parameters in the Self-Assessment Questionnaire including Overall Hair Volume (p=0.007), Scalp Coverage (p=0.002) and Thickness of Hair Body (p=0.003) (Table 2). After 180 days of treatment, Viviscal-treated subjects also reported significant improvements in Hair Shine (p<0.05), Skin Moisture Retention (p<0.05) and Skin Smoothness (p<0.05).
CONCLUSION
The daily administration of a proprietary nutritional supplement significantly increased hair growth after 90 and 180 days. Self-perceived improvements after 90 days were increased after 180 days of additional treatment, suggesting continued improvements may occur with ongoing treatment. No adverse events were reported. These results may represent the first description of increased hair growth in women associated with the use of a nutritional supplement. Based on these promising results, additional studies designed to further assess the use of Viviscal to increase hair thickness and hair counts in larger patient populations are currently under way.
ACKNOWLEDGMENT This study was sponsored by Lifes2good, Inc., Chicago, IL, USA.
DAY 90
DAY 90
Table 1. Changes in the Number of Terminal and Vellus Hairs, Mean (SD) Viviscal (N=10) Placebo (N=5)
Day 0
Terminal Hairs
FIGURE 1. Change in the Number of Terminal Hairs
600 500 400 300 200 100
0 Baseline * = p < 0.001 vs. placebo; ANOVA Day 90 Day 180 *
Viviscal Placebo
*
Vellus Hairs
Day 90 271.0 (24.2) 571.0 (65.7)a 46.5 (17.7) Day 180 609.5 (66.6)a 48.0 (16.2) 46.5 (14.4) ap<0.0001, each vs. placebo; repeated measures ANOVA Day 0 Day 90 Day 180 256.0 (24.1) 245.0 (22.4) 242.2 (26.9) 57.0 (32.1) 68.0 (21.4) 65.8 (16.6)
Table 2. Changes in Self-Assessment Questionnaire, Mean (SD) Viviscal (N=10)
Overall Hair Volume Scalp Coverage
Thickness of Hair Body Hair Shine
Skin Moisture Retention Skin Smoothness
ap = 0.007, b p = 0.002, c p = 0.003, d p < 0.0001, e
90 Days 2.8 (0.9)a 2.6 (0.8)b 2.9 (0.7)c 2.9 (1.1) 3.6 (0.8) 3.5 (0.7)
180 Days 1.8 (0.8)d 1.5 (0.9)d 2.0 (0.9)d 2.1 (1.3)e 3.0 (0.8)e 3.0 (0.8)e
p < 0.05, each vs. placebo; ANOVA.
Placebo (N=5)
90 Days 180 Days 4.2 (0.4) 4.2 (0.4) 4.2 (0.4) 3.6 (0.9) 4.0 (0.0) 4.0 (0.0)
3.8 (0.4) 4.0 (0.0) 4.0 (0.0) 3.6 (0.9) 4.0 (0.0) 4.0 (0.0)
FIGURE 2. Images of Patient Scalp at Baseline, 90 and 180 Days of Treatment
FIGURE 3. Images of Patient Scalp at Baseline, 90 and 180 Days of Treatment
DAY 0
DAY 0
DAY 180
DAY 180
Numeb r o f Teriman l Hairs
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