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 © 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

Abstract

A 12-week open-label, single-center clinical usage trial was conducted to determine the effectiveness of a dual product regimen consisting of a 0.5% retinol treatment and an anti-aging moisturizer with 30% vitamin C in women with mild to moderate hyperpigmented and photodamaged facial skin. Clinical grading of several efficacy parameters, tolerability evaluations, subject self-assessment questionnaires, and digital photography were completed at baseline and at weeks 4, 8, and 12. A total of 44 women completed the study. Effective ingredients incorporated into the 0.5% retinol treatment included encapsulated retinol for a retinol concentration of 0.5%, bakuchiol, and Ophiopogon japonicus root extract. The anti-aging moisturizer with 30% vitamin C contained 30% vitamin C in the form of tetrahexyldecyl ascorbate (THD ascorbate), alpha-tocopheryl acetate (vitamin E) and ubiquinone (coenzyme Q10). The facial regimen produced a statistically significant decrease (improvement) in clinical grading scores for all parameters assessed at weeks 8 and 12 when compared with baseline scores. In addition, the majority of these parameters were improved at week 4. The test regimen was well-perceived by the subjects for various inquiries regarding facial skin condition, product efficacy, and product attributes. Several tolerability parameters were assessed with no statistically significant increase except for dryness. A statistically significant increase in clinical grading scores for dryness on the face occurred at weeks 4 and 8 when compared to baseline scores. The increase in dryness is expected when introducing a retinol product to a facial regimen and the dryness did not persist to the week 12 time point.

J Drugs Dermatol. 2016;15(4):476-482.

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INTRODUCTION

Facial skin becomes photodamaged and ages over time, showing signs such as fine lines and wrinkles, reduction in clarity and brightness of the skin, an increase in redness and hyperpigmentation, and increased visual and tactile roughness.1 Fine lines and wrinkles arise due to the collagen breakdown and decreases in the amount of water held in the epidermis.2

A dual product regimen including a 0.5% retinol treatment and an anti-aging moisturizer with 30% vitamin C was developed to treat the skin on the face in order to improve the various signs of aging. The 0.5% retinol treatment contained 0.5% retinol encapsulated in porous microspheres. Use of retinol to improve photodamaged skin is well documented. Retinol has been shown to ameliorate ultraviolet (UV)-induced wrinkles, increase keratinocyte proliferation, induce the synthesis of new collagen in the dermis and inhibit the UV induction of matrix metalloproteinases (MMPs).3-6

The 2 major drawbacks of using retinol in a topical formulation are the lack of stability and the potential for irritation. The 0.5% retinol treatment incorporated retinol encapsulated in porous microspheres to counteract these drawbacks and enhance the stability and reduce the irritation.7 Additionally, the encapsulation also allowed for a sustained release effect of the retinol.8 The 0.5% retinol treatment also included bakuchiol and Ophiopogon japonicus root extract. Bakuchiol, a retinol-like functional compound, is a meroterpene phenol abundant in seeds and leaves of the plant Psoralea corylifolia.9 Bakuchiol has broad-spectrum antioxidant properties.9 It functions as an anti-aging compound through retinol-like regulation of gene expression and possesses anti-inflammatory, and antibacterial properties, among other positive effects.9-13 In addition, Bakuchiol has been shown to have an activity enhancing and a stabilizing effect on retinol.14 Ophiopogon japonicus root extract is hypothesized to improve and reinforce the barrier function of the skin, retaining its natural moisture.15

Vitamin C is known for its beneficial effects in treating aging skin.16 The anti-aging moisturizer with 30% vitamin C contained 30% vitamin C in the form of tetrahexyldecyl ascorbate (THD ascorbate), an efficacious and stable form of vitamin C.17 THD

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