Clinical Study to Evaluate the Efficacy and Tolerability of Cosmeceuticals Targeting the Dermal-Epidermal Junction

December 2021 | Volume 20 | Issue 12 | Original Article | 1314 | Copyright © December 2021

Published online December 1, 2021

Ajoa J. Addae BS,a Alisar S. Zahr PhD,a Lily I. Jiang PhD,b Seemal R. Desai MD FAAD,c Tatiana Kononov BS MBAa

aRevision Skincare®, Irving, TX
bSGS Stephens, Inc., Richardson, TX
cDepartment of Dermatology, The University of Texas Southwestern Medical Center & Innovative Dermatology, Dallas, TX

Objective: The dermal-epidermal junction (DEJ), composed of rare proteins, plays a significant role in facial skin aging. A newly enhanced multi-ingredient anti-aging facial moisturizer (MFM) and eye cream (MEC) were formulated to target DEJ-related aging. The objective of this study is to assess the efficacy and tolerability of a dual-product regimen MFM and MEC as a treatment in improving intrinsically and extrinsically aged facial and periorbital skin.
Method: Forty-two female subjects, 42 to 65 years, Fitzpatrick skin type I–VI, with mild to moderate droopy eyelids, moderate crow’s feet wrinkles, and moderate global photodamage completed this institutional review board (IRB)-approved study. Subjects applied the MFM and MEC twice-daily for 12 weeks. Clinical grading of efficacy and tolerability parameters, VISIA®-CR imaging, image analysis of wrinkles, skin pH, Tewameter, and pinch recoil measurements were performed at baseline, weeks 4, 8, and 12. Optical coherence tomography (OCT) imaging was performed at baseline and week 12.
Results: Statistically significant improvement was shown in both clinically graded parameters and bio-instrumentational analyses at all time points. Both products were well tolerated by subjects.
Conclusion: This IRB-approved clinical study demonstrated effectiveness in improving intrinsic and extrinsic signs of the global face and periorbital eye area aging after twelve weeks of twice-daily application.

J Drugs Dermatol. 2021;20(12):1314-1321. doi:10.36849/JDD.6355


Aging of the facial skin is predominantly controlled by both intrinsic factors, such as age-dependent degradation of skin structure, and extrinsic factors such as environmental stressors.1 Intrinsic and extrinsic aging of the facial skin can be visibly observed through outward signs such as fine lines, wrinkles, reduction in radiance, increase in redness, visual and tactile roughness, decrease in firmness, and visible pigmentation.1,2

The dermal-epidermal junction (DEJ), also known as the basement membrane, is a highly specialized structure located at the interface between cells and connective tissue.1,2 This junction is primarily composed of proteins including collagen IV, collagen VII, Laminin 5, fibronectin, and integrin.1,2 Intrinsic and extrinsic aging lead to a breakdown of the DEJ, a reduction in the rare proteins, a flattened appearance with reduced surface area and shortened rete ridges, loss of structural integrity, impaired communication between tissues, impaired skin adhesion, and increased skin fragility.1,2 Thus, the skin functions sub-optimally. Due to these findings, it can be concluded that the DEJ is a structure worthy of investigation and treatment.1,2 Previous reports have also shown that the facial skin is thicker in comparison to that of the periorbital area, which displays some of the body’s first signs of aging.2 As aging progresses, eyelid hooding, crepiness of the periorbital area, and crow’s feet occur.1-3 Therefore, a cosmeceutical treatment specific to the periorbital region must be formulated in such a way that not only addresses the DEJ, but also accounts for its structural difference to that of the global face.

While there is a multitude of literature centered on the deterioration of the DEJ, there still exists a need for cosmeceutical products that stabilize the junction by stimulating the synthesis of proteins at the DEJ. Previously, two cosmeceutical products