Efficacy and Tolerability of a Retinoid Eye Cream for Fine to Moderate Wrinkles of the Periorbital Region

September 2022 | Volume 21 | Issue 9 | 932 | Copyright © September 2022


Published online September 1, 2022

doi:10.36849/JDD.6815

Joely Kaufman MDa, Valerie D. Callender MD FAADb,c, Cherie Young MDc, Patricia Jones MDc, Mitchell Wortzman PhDd, Diane B. Nelson RN MPHd

aSkin Research Institute, Coral Gables, FL
bHoward University College of Medicine, Washington, DC
cCallender Dermatology and Cosmetic Center, Glenn Dale, MD
dSkinBetter Science LLC, Phoenix, AZ

Abstract
Introduction: The periorbital region is susceptible to premature skin aging and among the first areas to manifest age-related changes. Retinoids are highly effective but can be irritating, limiting use in this vulnerable area. A hydrating formulation comprised of a double-conjugated retinoid/alpha hydroxy acid (lactic acid; AHARet-EM) has been developed to address photoaging of the periorbital area. This study evaluated the efficacy, tolerability, and subject satisfaction of nightly application of AHARet-EM, and a regimen that included application of a peptide-rich eye cream (InF-E; AM) and AHARet-EM (PM).
Design: A 12-week, dual-center, open-label study evaluated nightly application of AHARet-EM in subjects 35 to 65 years of age with fine to moderate lines/wrinkles in the periorbital area (3-7 score based on the Fitzpatrick Classification Wrinkle Scale [FCWS]). A subset of subjects applied AHARet-EM (PM) and InF-E (AM). Investigator assessments at baseline and weeks 4, 8, and 12 were based on the 9-point FCWS for lines/wrinkles (1 [Fine Wrinkles] to 9 [Deep Wrinkles]) and a 6-point scale (0 [None] to 5 [Severe]) for texture, erythema, and under-eye darkness, puffiness, and dryness. Subject satisfaction and adverse events (AEs) were captured over 12 weeks.
Results: Twenty-six subjects, Fitzpatrick skin type III-VI, completed the study. Subjects applying AHARet-EM (n=16) demonstrated significant improvements from baseline at week 12 in the appearance of lines/wrinkles (33%; P<.0001), texture (37%, P<.0001), erythema (37%, P=.004), under-eye darkness (41%; P<.001), puffiness (55%, P<.0001) and dryness (94%, P<.0001). Significant improvements from baseline were demonstrated in subjects using the AM/PM regimen (n=10) at week 12 in the appearance of texture (33%; P=.002), erythema (68%; P=.001), under-eye darkness (32%; P=.007), puffiness (64%; P=.01) and dryness (90%; P<.0001). No AEs occurred related/possibly related to use of the study products. High levels of subject satisfaction were reported over 12 weeks.
Conclusion: Nightly application of a hydrating, double-conjugated retinoid eye cream demonstrated significant improvements in the appearance of lines/wrinkles, under-eye darkness, puffiness, and dryness of the periorbital area at week 12. Morning application of a peptide-rich eye cream afforded additional benefits. The study products were non-irritating, and subjects reported high levels of satisfaction throughout the study.

J Drugs Dermatol. 2022;21(9):932-937. doi:10.36849/JDD.6815

INTRODUCTION

Thinner than other regions of the face, possessing fewer oil glands, and subject to repetitive contractions, skin around the eyes is particularly susceptible to environmental factors and accelerated skin aging.1-5 Consequently, the periorbital region is among the first areas to experience intrinsic age-related changes and, thus, one of the first areas for which patients seek treatment advice. Thinning and drying of periorbital skin can manifest as early as the third decade of life.1,3,5,6-8 Anatomical alterations to tissue structures of the face that occur with aging arise from volume loss, deflation, and atrophy of malar fat and soft tissue. Additionally, underlying changes to bony structures, including enlargement of the orbital bony space, results in a more pronounced, concave tear trough deformity. Under-eye hyperpigmentation is a common, sometimes hereditary change that may be related to ethnicity and the result of thinning periorbital skin and can be particularly challenging to ameliorate.9 Extrinsic aging, owing to chronic exposure to ultraviolet radiation and other environmental stresses, compounds the consequences of intrinsic aging and can lead to fine lines and wrinkles, poor skin texture, and skin discoloration.10 As a result of both intrinsic and extrinsic aging of the periorbital region, individuals may develop