One-year Topical Stabilized Retinol Treatment Improves Photodamaged Skin in a Double-blind, Vehicle-controlled Trial

March 2015 | Volume 14 | Issue 3 | Original Article | 271 | Copyright © 2015

Manpreeet Randhawa PhD,a Dianne Rossetti BSc,a James J. Leyden MD,b Jared Fantasia MSc,a
Joshua Zeichner MD,c Gabriela Oana Cula PhD,a Michael Southall PhD,a and Samantha Tucker-Samaras PhDa

aSkin Research Center, Johnson and Johnson Consumer Companies, Inc. Skillman, NJ
bKGL Skin Study Center, Broomall, PA
cDepartment of Dermatology Mount Sinai Hospital, New York, NY

Abstract

BACKGROUND: Retinol, a precursor of retinoic acid, has great potentials as a topical anti-aging molecule; however, only a handful of clinical investigations have been published to date.
OBJECTIVE: This study aimed to assess the efficacy and safety of 0.1% stabilized retinol on photodamaged skin during a one-year treatment.
METHODS: The investigation included two 52-week, double-blind, vehicle-controlled studies. In the main study, 62 subjects applied either a stabilized retinol formulation or its vehicle to the full face. A second exploratory study evaluated histological/histochemical markers in 12 subjects after 52 weeks of either retinol or vehicle use on contralateral dorsal forearms.
RESULTS: The retinol group showed significant photodamage improvement over vehicle at all timepoints during the study. After 52 weeks, retinol had improved crow’s feet fine lines by 44%, and mottled pigmentation by 84%, with over 50% of subjects showing +2 grades of improvement in many parameters. Additionally, at week 52, histochemical data confirmed the clinical results, showing increased expression of type I procollagen, hyaluronan, and Ki67 as compared to vehicle
CONCLUSION: This study confirms that a stabilized retinol (0.1%) formulation can significantly improve the signs of photoaging, and improvements in photodamage continue with prolonged use.

J Drugs Dermatol. 2015;14(3):271-276.

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INTRODUCTION

As people age, they become increasingly concerned with their skin appearance, especially on photoexposed areas. The changes that derive from chronic sun exposure superimposed on intrinsically aged skin are collectively known as photoaging. Clinically, this presents with leathery and yellowish appearance, irregular pigmentation, coarse wrinkles (or severe atrophy depending on the person), lack of skin elasticity, and often neoplasia, which at times may be malignant. 1,2 Histologically, photoaging shows keratinocyte atypia, variability in epidermal thickness and melanocyte distribution, loss of epidermal polarity, loss and alteration of dermal matrix, and, especially, degeneration of elastic fibers (elastosis).2-4

Many topical agents are currently marketed for the improvement of phodamaged skin. Among these, tretinoin (all-trans-retinoic acid) is considered the gold standard and numerous clinical trials have independently confirmed its ability to partially reverse photoaged skin at the clinical, histological, and molecular level. (Leyden 1989, Singh 2006).5,6 The main drawback of tretinoin, however, is the frequency of skin irritation. Additionally, it is available only by prescription, and thus accessible only to a limited population. This has led the industry to research alternatives in the area of active cosmetics (cosmeceuticals) for photoaging.

A precursor of tretinoin, retinol has great potentials as an anti-aging molecule and a long history of use as an antioxidant in cosmetic formulations. Applied to skin, retinol has been shown to penetrate the barrier7 and to induce clinical and histological changes without signs of irritation.8 However, only a handful of clinical studies have been published in peer-reviewed journals on the benefits of retinol in aging9 and photoaging.10 One reason could be that retinol is very unstable; thus, retaining the bioactivity of retinol in commercial products is challenging. Recently, a vehicle-controlled study by Tucker-Samaras et al. found that a formulation of 0.1% stabilized retinol was able to significantly improve facial photodamage after just 8 weeks of use.10

The aim of the current study was to assess the efficacy and safety of 0.1% stabilized retinol in photoaging for longer periods of use (52 weeks) and to document histological and histochemical changes after treatment for 52 weeks.

METHODS

Two 52-week, double-blind, vehicle-controlled studies were designed to evaluate the efficacy and safety of a topical retinol formulation in photoaging. One study (Clinical Study) evaluated clinical improvements after application of either a retinol

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