3.7% by day 90 and 9.97% by day 180 for the active treatment group compared to -0.2% and -0.2%, respectively, for the placebo group. The vellus hair counts significantly increased for the active treatment group (P<0.05) by day 180 while significantly decreasing for the placebo group subjects (Figure 3), translating into a significant percent change of 10.78% and -3.38%, respectively. The mean target area hair counts for these endpoints are summarized in Table 3.
Secondary Endpoints
Hair shedding count progressively and significantly decreased among active group subjects culminating in a decrease of about one-third (-32.41%) by day 180 relative to baseline (P<0.01). Conversely, the percentage change in shed counts initially increased for placebo group subjects and then decreased at day 180 relative to baseline by -10.08% and did not reach statistical significance (Table 4; Figure 4).
Blinded investigator global hair assessments showed a progressive and significant improvement for the active group compared with the placebo group at day 180 on both hair growth and quality scales. Global hair growth improvement ratings were recorded for 30% of active group subjects at day 90 and for 73% at day 180, while only 11% of placebo group subjects received global hair growth improvement ratings at day 90 and 22% at day 180. The difference in improvement ratings between treatment groups on day 180 was significant (P<0.05; Figure 5). Global hair quality improvement ratings were also significantly different between active (42%) and placebo (15%) groups at day 180 (P<0.05; Figure 6).
Seventy-three percent of subjects in the active group were satisfied (either slightly, moderately, extremely) with their treatment at day 180. Self-Assessment questionnaire revealed that 30% of subjects in the active group reported a 2-point
Hair shedding count progressively and significantly decreased among active group subjects culminating in a decrease of about one-third (-32.41%) by day 180 relative to baseline (P<0.01). Conversely, the percentage change in shed counts initially increased for placebo group subjects and then decreased at day 180 relative to baseline by -10.08% and did not reach statistical significance (Table 4; Figure 4).
Blinded investigator global hair assessments showed a progressive and significant improvement for the active group compared with the placebo group at day 180 on both hair growth and quality scales. Global hair growth improvement ratings were recorded for 30% of active group subjects at day 90 and for 73% at day 180, while only 11% of placebo group subjects received global hair growth improvement ratings at day 90 and 22% at day 180. The difference in improvement ratings between treatment groups on day 180 was significant (P<0.05; Figure 5). Global hair quality improvement ratings were also significantly different between active (42%) and placebo (15%) groups at day 180 (P<0.05; Figure 6).
Seventy-three percent of subjects in the active group were satisfied (either slightly, moderately, extremely) with their treatment at day 180. Self-Assessment questionnaire revealed that 30% of subjects in the active group reported a 2-point
