A Double-blind, Randomized, ControlledClinical Trial Evaluating the Efficacy and Toleranceof a Novel Phenolic Antioxidant Skin Care SystemContaining Coffea arabica and ConcentratedFruit and Vegetable Extracts
December 2010 | Volume 9 | Issue 12 | Original Article | 1480 | Copyright © December 2010
Debbie M. Palmer DO and Jennifer Silverman Kitchin MD
Objective: This 12-week, double-blinded, randomized, controlled clinical usage study was conducted to evaluate the efficacy and tolerance of a novel topical, multi-ingredient, polyphenol, high antioxidant skin care system (facial wash, day lotion, night crème and eye serum) to reduce the appearance of photoaging. Methods: A total of 40 Caucasian female participants were randomly assigned to apply the test regimen or control regimen for 12 weeks. One group washed with the test antioxidant facial wash twice daily, applied the test antioxidant day lotion each morning and the test antioxidant night creme and eye serum each evening. The second group washed with a control facial wash twice daily and applied a control moisturizer each morning and evening. Clinical evaluations for efficacy were made by a board-certified dermatologist at baseline and after six and 12 weeks of product use. Efficacy was also measured by subjects’ self-assessments and via photography
and instrumentation. Results and Conclusion: Overall, the results of the study showed that the test regimen produced statistically significant improvements in the appearance of photodamaged skin. Most impressive was the significantly greater improvements produced by the test regimen over the control regimen for nearly every grading parameter. The results from this study demonstrate that this high Total ORACsc scoring antioxidant skin care system was well tolerated, with no adverse events reported by the participants during the course of the study, and improved, significantly greater than a control regimen, the appearance of wrinkles, firmness, hyper pigmentation, blotchy redness, tactile roughness and clarity in photodamaged skin. Post-baseline clinical grading scores, silicone replica parameters, cutometer and corneometer scores were statistically compared to baseline using a paired t test at the P≤0.05 significance level.