Efficacy and Tolerability of Topical 0.1% Stabilized Bioactive Retinol for Photoaging: A Vehicle-Controlled Integrated Analysis

April 2024 | Volume 23 | Issue 4 | 209 | Copyright © April 2024


Published online February 13, 2024

Patricia Farris MDa, Diane Berson MDb, Neal Bhatia MDc, David Goldberg MD JDd,e, Edward Lain MD MBAf,g, Kavita Mariwalla MDh, Joshua Zeichner MDe, Dara Miller i, Tony McGuire MSi, Menas Kizoulis i

ªDepartment of Dermatology, Tulane University School of Medicine, New Orleans, LA
bDepartment of Dermatology, Cornell University Weill Medical College, Weill Cornell Medical Center, New York, NY
cTherapeutics Clinical Research, San Diego, CA 
dSkin Laser and Surgery Specialists, A Division of Schweiger Dermatology Group, Hackensack, NJ 
eDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY 
fSanova Dermatology, Austin TX 
gAustin Institute for Clinical Research, Austin, TX 
hMariwalla Dermatology, West Islip, NY
iKenvue Inc., Skillman, NJ 

Abstract


Introduction: Chronic exposure to ultraviolet light photoages skin. Retinol, a precursor molecule to retinoic acid that causes less irritation, is available as a nonprescription, cosmetic retinoid and improves collagen production, skin elasticity, and signs of photoaging. Advances in formulation science have allowed the production of stabilized bioactive retinol formulations. This integrated analysis aims to build on previous studies and further examine the comprehensive efficacy and tolerability of topical 0.1% stabilized bioactive retinol.
Methods: This analysis included 6 vehicle-controlled studies of 0.1% stabilized bioactive retinol in women with mild-to-moderate signs of photodamage. Across all studies, the same dermatologist investigator assessed overall photodamage; wrinkles on the forehead, cheeks, and undereye area; crow's feet wrinkles and fine lines; lack of even skin tone; and brown spots at baseline and weeks 4, 8, and 12 on a numerical scale. Tolerability was also assessed.
Results: Participants (retinol, N=237; vehicle, N=234) had a mean (SD) age of 47.4 (6.6) years. Retinol induced greater improvements from baseline in all signs of photoaging vs vehicle as early as week 4 and through 12 weeks of application. Few participants experienced irritation; all events were mild to moderate and transient. The most common signs of irritation were erythema (n=2) and skin scaling/peeling (n=5).
Conclusions: This pooled analysis of 6 vehicle-controlled clinical studies provides new evidence for the efficacy of 0.1% stabilized bioactive retinol in improving signs of photoaging without causing major irritation. Topical 0.1% stabilized bioactive retinol was well tolerated with only a few reported cases of skin irritation.

J Drugs Dermatol. 2024;23(4):209-215.     doi:10.36849/JDD.8124

INTRODUCTION

Chronic exposure to ultraviolet light compromises the structural integrity of the skin and results in premature signs of aging, including facial fine lines and wrinkles, lack of even skin tone, brown spots, and overall photodamage. Collectively, these changes are referred to as photoaging.1,2

Cosmetic and prescription retinoids are used to improve the visible signs of a variety of dermatoses, including photoaging.3,4 Retinoic acid is the most active form of vitamin A within the cell, and after binding to nuclear receptors, retinoic acid directly or indirectly induces the expression of genes involved in cellular proliferation and differentiation.4-6 Retinoids are widely used to improve the signs of photoaging, and their benefits have been confirmed in numerous well-designed studies.7-10 Unfortunately, prescription retinoids, such as retinoic acid, can lead to skin irritation (including erythema, burning, and scaling), referred to as retinoid dermatitis,11 and they are less accessible than nonprescription, cosmetic retinoids.

Precursors to retinoic acid produce less skin irritation than retinoic acid because they are converted into retinoic acid by rate-limiting enzymatic steps, limiting the amount of 
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