A self-perception questionnaire was also completed by each
participant at baseline and weeks two, four, six, eight, ten, and
twelve, the endpoint of the study. The questionnaire measured
perceived product performance and the improvements or
outcomes the participants identified in their skin after use. The
aggregate responses were assessed to determine statistical
significance.
METHODS
The test product was dispensed to the participants at the day 0 appointment. Due to the known potential for irritation with the application of any retinoids, the study participants were advised to introduce the test product slowly into their nighttime regimen to allow for skin accommodation to the retinol. In the first two weeks, they were told to use the test product three times per week (day 0, day 2, day 4, day 7, day 9, day 11) in the evenings only. In weeks three to twelve, the participants were instructed to use the product nightly. No participants experienced irritation or sensitivity to the test product when used as directed; limited use in the first two weeks and every evening in weeks three to twelve of the study.
In addition to the test product, participants were given marketed ancillary products (facial cleanser, a moisturizer, and a broadspectrum sunscreen product) for daily use. The regimen was as follows:
Morning: wash with facial cleanser and apply the sunscreen product. No additional products are to be used.
Evening: wash with facial cleanser and apply retinol test product. Apply moisturizer as needed. No additional products are to be used.
Each participant returned to the test site every two weeks for an assessment by the Study Originator/Supervisor. At these appointments, images and data were captured using the Canfield Visia® imaging technology. This enabled the capture of consistent light images as well as detailed filters that elucidated changes that may not be clinically apparent to the naked eye. Percentages of improvement in comparison to the broader population was also provided through the Visia® technology.
In addition to the test product, participants were given marketed ancillary products (facial cleanser, a moisturizer, and a broadspectrum sunscreen product) for daily use. The regimen was as follows:
Morning: wash with facial cleanser and apply the sunscreen product. No additional products are to be used.
Evening: wash with facial cleanser and apply retinol test product. Apply moisturizer as needed. No additional products are to be used.
Each participant returned to the test site every two weeks for an assessment by the Study Originator/Supervisor. At these appointments, images and data were captured using the Canfield Visia® imaging technology. This enabled the capture of consistent light images as well as detailed filters that elucidated changes that may not be clinically apparent to the naked eye. Percentages of improvement in comparison to the broader population was also provided through the Visia® technology.
RESULTS AND STATISTICAL ANALYSIS
The dermatologist assessment, self-assessment, and instrument filter data were analyzed by first calculating the 12-week change from baseline (t=0). In all cases, the change was calculated such that a larger, more positive difference ("Diff") indicated a better/ more favorable outcome. A two-sided Wilcoxon signed rank test was used to test if the median change in each case was statistically different from zero (ie, no change). A test resulting in a P-value of 0.05 or less indicated a statistically significant change.
Dermatologist Assessment
After the 12-week timepoint, the dermatologist investigator determined through analysis of Visia® images that over half of the participants (7 of 13) to have had a statistically significant improvement (P=0.022) in their overall skin condition and appearance. (Figures 1a, 1b, 2a, and 2b) Additionally, during the course of the study, there was no evidence of product irritation visually observed by clinical staff or reported by participants, demonstrating product tolerability.
Dermatologist Assessment
After the 12-week timepoint, the dermatologist investigator determined through analysis of Visia® images that over half of the participants (7 of 13) to have had a statistically significant improvement (P=0.022) in their overall skin condition and appearance. (Figures 1a, 1b, 2a, and 2b) Additionally, during the course of the study, there was no evidence of product irritation visually observed by clinical staff or reported by participants, demonstrating product tolerability.
