An Open Label Clinical Trial to Evaluate the Efficacy and Tolerance of a Retinol and Vitamin C Facial Regimen in Women With Mild-to-Moderate Hyperpigmentation and Photodamaged Facial Skin

April 2016 | Volume 15 | Issue 4 | Original Article | 476 | Copyright © April 2016


James H. Herndon Jr. MD,a Lily I. Jiang PhD,a Tatiana Kononov BS MBA,b and Theresa Fox BSb

aThomas J. Stephens and Associates, Richardson, TX
bRevision Skincare, Irving, TX

use of the test materials. The increase in dryness and frequency of AEs is typical for introducing a retinol product to a facial skin care regimen, and the majority of the AEs were resolved with time as the skin became acclimated to regular application of retinol. Some AEs were resolved after modifying the use of the test materials. Additionally, the tolerability of the product was deemed favorable when noting the self-assessment questionnaire results of 72% and 86% of the subjects agreeing that “My skin feels more moisturized” and 81% and 93% of the subjects agreeing that “Overall, the products were mild and did not irritate my skin” at week 8 and week 12, respectively.
The test regimen was well-perceived by the subjects under the conditions of this test for various inquiries regarding facial skin condition, product efficacy, and product attributes. After 12 weeks of usage, 86% of subjects indicated desire to purchase the products.
A limitation of this study includes the lack of a control product.

CONCLUSION

A 12-week single-center clinical usage study was conducted to test a 0.5% retinol treatment and an anti-aging moisturizer with 30% vitamin C in 44 women with mild-to-moderate hyperpigmentation and photodamaged skin. The facial regimen produced a statistically significant decrease (improvement) in clinical grading scores for all parameters assessed including clarity/brightness, fine lines, evenness of skin tone (redness), firmness, global hyperpigmentation (mottled), global hyperpigmentation (discrete), overall photodamage, radiance, skin tone (color) evenness, tactile smoothness, visual smoothness, and wrinkles at weeks 8 and 12 when compared with baseline scores. In addition, the majority of these parameters were also improved at week 4. Moreover, as indicated by responses on the self-assessment questionnaire, the subjects believed in the efficacy of the product and were interested in purchasing it. Digital photography further supported these results. The study illustrated that the combination of efficacious ingredients in each product and using the products in a dual regimen provided a broad anti-aging effect with good tolerability. These results provide medical professionals with information that may benefit patients seeking treatment for hyperpigmentation or photodamaged facial skin.

DISCLOSURES

This study was 100% sponsored by Revision Skincare. The authors have no conflicts of interest to declare.

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AUTHOR CORRESPONDENCE

Tatiana Kononov BS MBA……..................... tkononov@revisionskincare.com
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