A Randomized, Double-Blind, Controlled Comparative Trial of the Anti-Aging Properties of Non-Prescription Tri-Retinol 1.1% vs. Prescription Tretinoin 0.025%

January 2012 | Volume 11 | Issue 1 | Original Article | 64 | Copyright © 2012

Elizabeth T. Ho BS,a Nathan S. Trookman MD,b Brian R. Sperber MD PhD,b Ronald L. Rizer PhD,c Ralph Spindler PhD,d Sujatha Sonti PhD,a Vincent Gotz MS Pharm,e Rahul Mehta PhDa

aSkinMedica, Inc., Carlsbad, CA bColorado Springs Dermatology Clinic, Colorado Springs, CO cThomas J. Stephens & Associates, Colorado Springs, CO dAMCOL Health and Beauty Solutions, Inc., Hoffman Estates, IL eProPharmaCon LLC, Carlsbad, CA

Abstract

Vitamin A and its derivatives (commonly termed retinoids) are widely used in topical anti-aging products. Certain retinoids such as retinol and its esters are available without a prescription, while others such as tretinoin are available only via prescription. A randomized, double-blind, controlled clinical study was conducted to compare the efficacy and tolerability of a tri-retinol 1.1% gradual release cream vs. tretinoin 0.025% cream in females with mild-to-moderate facial photodamage. Subjects applied the test product to the entire face in the evening after cleansing in a progressively increasing frequency starting twice weekly for the first week, followed by three times weekly during the second week and then daily as tolerated for the third week and beyond. Treatment was continued for a total of three months. Clinical evaluations and standardized digital photographs were performed at baseline and after four, eight, and 12 weeks of treatment. Self-assessment questionnaires were completed by the subjects at four, eight, and 12 weeks to assess perceived efficacy of the test products. Thirty-four subjects (16: tri-retinol and 18: tretinoin) completed the study. Both test products significantly improved signs of photodamage, including fine and coarse periocular wrinkles, skin firmness, skin tone, mottled pigmentation, tactile roughness, overall photodamage and global photodamage improvement. There were no significant differences in efficacy between the two products for these assessments. The adverse effects (which were graded as mild or less) were those typically seen with topical retinoids. Subjects reported >93 percent overall satisfaction with both products at weeks 8 and 12.

J Drugs Dermatol. 2012;11(1):64-69.

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INTRODUCTION

Retinoids are a class of natural and synthetic vitamin A derivatives. As lipophilic compounds, they can diffuse though cellular membranes, bind to nuclear receptors and modulate the expression of epidermal genes (e.g., CRABP2 and HBEGF) involved in cellular proliferation and differentiation.1-2 For decades, tretinoin has been used to successfully treat the signs of skin aging, such as rhytides, xerosis, laxity and dyschromia. These visual signs of aging skin result from both structural and metabolic changes due to the passage of time (intrinsic, chronological or natural aging) and from environmental insults, primarily repeated exposure to ultraviolet radiation (photoaging).3-5 There is strong evidence that chronological aging and photoaging share molecular and biological features, particularly in older individuals, and that retinoids are able to repair both photoaged and intrinsically aged skin.6-8 At a cellular and molecular level, epidermal thinning results from a decrease in keratinocyte turnover and dermal thinning due to a decreased number of fibroblasts, decreased collagen synthesis, and increased degradation of collagen by matrix metalloproteinases.9 The beneficial clinical effects of tretinoin are thought to result from 1) inhibition of matrix metalloproteinase production and 2) stimulation of the synthesis of collagens and fibrillin.8,10-11

Cosmetic anti-aging products are generally presumed to be less effective than the prescription product, tretinoin. A recent review concluded that evidence supporting retinoid-based cosmeceutical anti-aging products is sparse.12 Studies on naturally aged or sun-

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