An Open Label Clinical Trial of a Multi-Ingredient Anti-Aging Moisturizer Designed to Improve the Appearance of Facial Skin

July 2015 | Volume 14 | Issue 7 | Original Article | 699 | Copyright © 2015

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

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

Abstract

An open label clinical trial was conducted to determine the effectiveness of a multi-ingredient anti-aging moisturizer designed to improve the appearance of facial skin. Parameters studied included fine lines and wrinkles, clarity/brightness, visual roughness, tactile roughness, evenness of skin tone (redness), evenness of skin tone (hyperpigmentation) and overall appearance. Thirty-seven female subjects, ages 35-60 years completed the study. Effective ingredients incorporated into the facial anti-aging moisturizer include: 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). Subjects were instructed to apply the moisturizer twice daily, once in the morning and once in the evening. Subjects were evaluated at baseline and after 4, 8, and 12 weeks of product usage. Clinical evaluations were conducted at each visit. A self-assessment questionnaire was conducted at week 4, week 8, and week 12. The self-assessment questionnaire included product efficacy inquiries and product aesthetic inquiries. Digital photography was conducted at baseline, week 8, and week 12. After 8 weeks of twice daily use, clinical evaluation results show that the multi-ingredient anti-aging moisturizer produced a statistically significant improvement in the scores of all clinical grading parameters assessed compared to baseline. A greater statistically significant improvement was seen at 12 weeks. At week 12, there was a statistically significant percentage of favorable results versus unfavorable results in all product efficacy and product aesthetic self-assessment questionnaire results. Digital photography supported the clinical grading and self-assessment questionnaire results. Additionally, the multi-ingredient anti-aging moisturizer is judged to be mild and well tolerated. Several tolerability parameters were assessed at all time points with no statistically significant increase in any of the scores compared to baseline.

J Drugs Dermatol. 2015;14(7):699-704.

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INTRODUCTION

The condition of the skin on the face deteriorates with age.1 Signs of aging facial skin include: fine lines and wrinkles, reduction in clarity/brightness of the skin, increase in visual and tactile roughness, increase in redness, and increase in hyperpigmentation. A multi-ingredient anti-aging moisturizer was designed to treat the skin on the face in order to improve the signs of aging. Effective ingredients incorporated into the treatment include: 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). The combination of the effective ingredients listed above is expected to have a beneficial impact on the signs of aging skin. Previous studies have demonstrated the effectiveness of these ingredients. Cycloartane-type saponins, phytocompounds found in the Astragalus root, have been shown to promote wound healing through increased fibroblast proliferation and migration.2 Hong et al found that Astragalus embranaceus root had an inhibitory effect on matrix metalloproteinase-1 collagenase expression and procollagen expression on UVB irradiated human dermal fibroblasts.3 Concerning peptides used in skincare, Lintner and Peschard demonstrated that topically delivered peptides with a fatty acid group attachment have biological activity in improving the skin and its properties.4 The specific peptide, palmitoyl tripeptide-38, has shown activity in upregulating collagens I and III, fibronectin, and hylauronic acid in the dermis while also boosting key proteins of the dermal-epidermal junction, collagen IV and laminins.5 Soo Lee’s work demonstrates that ursolic acid may be useful in inhibiting UVA-induced photoaging.6 It is known that Vitamin C is very beneficial for treating aging skin.7,8 THD ascorbate has been shown to be an efficacious and stable form of Vitamin C.9 Ochiai et al showed that THD ascorbate has skin lightening effects.10 Xiao et al demonstrated that THD Ascorbate has protective effects in the presence of UVA radiation.11 Coenzyme Q10 has multiple known topical benefits including antioxidant, energizing and wrinkle inhibitory effects.12,13 Incorporating this described combination of ingredients at efficacious levels into a moisturizing cream base should produce a statistically significant anti-aging result.

OBJECTIVE

To assess the long-term efficacy of a multi-ingredient anti-aging moisturizer in improving the following parameters: 1) fine lines 2) wrinkles 3) clarity/brightness 4) visual roughness 5) tactile roughness 6) evenness of skin tone (redness) 7) even

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