ness of skin tone (hyperpigmentation) 8) overall appearance. Additionally, to assess the perception of the product efficacy and product aesthetic attributes by users through a self-assessment
questionnaire.
Material and Methods
A multi-ingredient anti-aging moisturizer was formulated to address the multiple signs of aging of the facial skin. This formulation
included Astragalus membranaceus root extract, a peptide blend including palmitoyl tripeptide-38, standardized rosemary leaf extract (ursolic acid), tetrahexyldecyl ascorbate (THD ascorbate) and ubiquinone (coenzyme Q10), in a moisturizing
oil-in-water emulsion base. A 12-week efficacy study was completed by 37 female subjects in the age range of 35–60 years. Qualified subjects exhibited mild to moderate facial wrinkles and uneven skin tone. The demographic information is shown in Figure 1. The subjects were instructed to apply the treatment evenly to the face twice daily, once in the morning and once in the evening. Subject visits to the testing facility occurred
at baseline, week 4, week 8 and week 12. Subject diaries were collected at each visit and reviewed for compliance and comments. Additionally, units of the test materials were collected,
each visually inspected, and weighed for study compliance. Clinical evaluations of each subject were conducted during all visits by an expert grader using the scale shown in Figure 2. A self-assessment questionnaire was also conducted at week 4, week 8, and week 12, which included both product efficacy and product aesthetic inquiries.
For clinical grading efficacy, mean percentage change and percentage
of subjects improved or worsened were calculated and reported at the post-baseline time points. Treatment comparisons
were made in terms of change from baseline at all post-baseline time points. The null hypothesis that the mean change from baseline is zero was tested using the Wilcoxon signed-rank test. All statistical tests were performed at significance
level alpha=0.05. Statistical analyses were performed using SAS software version 9.30 series (SAS Statistical Institute).
Electronic data capture (EDC) methods were used to record clinical grading efficacy. The EDC used is compliant with FDA regulations.
For self-assessment questionnaires, subjects completed a sponsor-provided self- assessment questionnaire that included product efficacy inquiries regarding subjects’ perceptions of skin condition parameters as well as product aesthetic inquiries
regarding subjects’ perceptions of the product attribute parameters. Inquiries were completed at each post-baseline time point and were tabulated and the frequency and percentage
of all response options was reported for each question and time point. A binomial (sign) test was performed to test if the proportion of the combined designated favorable responses was equal to the combined designated negative responses for applicable questions.
Digital photography was used to document each subject’s condition during the baseline, week 8, and week 12 visit. Each subject had a total of 3 full-face images taken under visible light and cross-polarized light using the VISIA CR photo-station (Canfield
Imaging Systems, Fairfield, NJ) with a Canon Mark II 5D digital SLR camera (Canon Incorporated, Tokyo, Japan). The 3 full-face images consisted of a right side view, left side view,
