months, the mean number of terminal hairs progressively increased from 68.1 at day 0 to 77.2 at day 360, corresponding to a significant 13.4 % improvement (P<0.0001; Figure 2). The mean vellus hair counts significantly increased by 8.3% from day 0 to day 180 (P<0.05), but then decreased to baseline levels by day 360. The mean number of total hairs progressively increased from 78.4 at day 0 to 87.58 at day 360, representing a significant 11.7% improvement (P<0.0001). The mean baseline hair washing shed count progressively and significantly decreased by 43.2% (16.6 hairs) on day 180 (P<0.01), remaining stable through day 360 (P<0.01 vs baseline; Table 2).
Blinded investigator global hair assessments showed progressive and significant improvement among subjects receiving the active supplement over the entire 360 days. There was a statistically significant increase in Global Hair Growth Improvement ratings from 43% on day 90 to day 180 (P<0.001) and 25% from day 90 to day 360. Global Hair Quality Improvement scores significantly increased by 24% from day 90 to day 180 (P<0.05) and by 37% from day 90 to day 360 (P<0.005). Figure 3 shows improvements in hair growth and quality for representative subjects treated with the active product for 12 months.
Changes Within the Initial Placebo Group
When placebo group subjects were compared directly to the active group during Phase I of the study, there was no evidence of any change in the mean total or mean terminal hair counts and there was a small yet significant decrease in the mean vellus hair counts. The shed counts initially increased and then decreased at day 180 relative to baseline but did not reach statistical significance. Blinded investigator global hair assessments showed a non-significant increase in ratings for Hair Growth (22%) and Hair Quality (15%) Improvements.16
