The per-protocol population was the primary population for all statistical analyses and included all subjects who received treatment and completed the study according to protocol.
The mean of the change from baseline (defined as post-baseline
value minus baseline value) was estimated at post-baseline timepoints. The null hypothesis that the mean change from baseline was 0 was tested using the Wilcoxon Signed Rank Test. All statistical tests were 2-sided at significance level α = 0.05. Statistical analyses were performed using SAS software version
9.30 series (SAS Statistical Institute).
RESULTS
Clinical Grading of Efficacy Parameter
Use of the 0.5% retinol treatment and the anti-aging moisturizer with 30% vitamin C produced a statistically significant decrease (improvement) in clinical grading scores for all parameters assessed at weeks 8 and 12, including: clarity/brightness, fine lines, evenness of skin tone (redness), firmness, global hyperpigmentation (mottled and discrete), overall photodamage,
radiance, skin tone (color) evenness, tactile smoothness, and visual smoothness and wrinkles at weeks 8 and 12 when compared with baseline scores. There was also a statistically significant decrease (improvement) in clinical grading scores for many parameters at the week 4 timepoint, including: clarity/brightness, fine lines, evenness of skin tone (redness), global
