A Double-Blind, 12-Week Study to Evaluate the Antiaging Efficacy of a Cream Containing the NFκB Inhibitor 4-Hexyl-1, 3-Phenylenediol and Ascorbic Acid-2 Glucoside in Adult Females

June 2016 | Volume 15 | Issue 6 | Original Article | 750 | Copyright © 2016

Romain Roure MS,a Virginie Nollent Pharm.D,a Liliane Dayan MD,b Etienne Camel Pharm.D,c
Christiane Bertin MSa

aJohnson & Johnson Santé Beauté France, Issy les Moulineaux, France
bIndependent Consultant Dermatologist, Paris, France
cI.E.C. France, Lyon, France

Abstract

The 5 main physical manifestations of aged skin are wrinkles, uneven tone, brown spots, loss of elasticity, and dryness. One mechanism resulting in these physical manifestations is increased activity of the nuclear factor kappa B (NFκB) protein. This 12-week, double-blind, placebo-controlled, randomized split-face study compared the antiaging effect and safety of a face cream containing 4-Hexyl-1, 3-phenylenediol, an NFκB inhibitor, and ascorbic acid-2 glucoside versus placebo in adult females aged 45–70 years old. Subjects (n=42) applied active treatment or placebo to the same half face twice daily at home for 12 weeks. Clinical evaluation was carried out by a dermatologist. Subjects carried out similar self-grading assessments. Colorimetric measurements analyzed skin color, and biomechanical skin properties were evaluated. Clinical grading showed that most wrinkle parameters were significantly improved after 8 weeks of active treatment compared with baseline and placebo (P≤.05), with improvements maintained after 12 weeks. Only Marionette wrinkles did not show a significant improvement. Brown spots (color intensity/number), overall photodamage, and most complexion parameters improved significantly after 8 and 12 weeks compared with baseline and placebo (P≤.05). Self-grading yielded similar results compared with baseline. Self-grading did not demonstrate improvements with active treatment versus placebo, except for skin firmness at 8 and 12 weeks (P≤.05). A significant difference was seen with active treatment compared with placebo in all colorimetric parameters (L*, b*, and ITA°) after 8 weeks, and in spot coloration (b*) after 12 weeks (P<.05). Improvements in skin elasticity were not significantly different between treatments. Overall tolerability of active treatment was judged as good. In conclusion, a cream containing 4-Hexyl-1, 3-phenylenediol and ascorbic acid-2 glucoside improves the clinical appearance of aged skin, validating the potential use of NFκB inhibition as a novel, effective method of topical antiaging.

J Drugs Dermatol. 2016;15(6):750-758.

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INTRODUCTION

Skin aging as a result of chronologic (intrinsic) aging and photodamage (extrinsic) is a complex process that causes a significant change in the appearance and texture of the skin.1 Chronologic aging is mainly associated with a decrease in collagen. This is due to reduced collagen synthesis and increased degradation via an increase in matrix metalloproteinase (MMP) expression, a decrease in the extracellular matrix, and a reduction in elastin.2 Photodamage as a result of continued exposure to ultraviolet radiation increases levels of MMP in the dermis and epidermis, which results in deterioration of collagen and elastin, as well as other components of the dermal extracellular matrix.3 Invisible flaws in the repaired dermal matrix, with repeated cycles of exposure to ultraviolet radiation, eventually result in visible changes to the skin.4 As a result of these physiological modifications of the skin structure that occur with aging, the 5 main physical manifestations of aged skin are wrinkles, uneven tone, brown spots, loss of elasticity, and dryness.5,6

One of the mechanisms resulting in the physical manifestations of aging is increased activity of the nuclear factor kappa B (NFκB) protein. NFκB is a redox-sensitive transcription factor that coordinates regulators of immunity, inflammation, development, cell proliferation, and survival.7 NFκB, when activated by ultraviolet radiation, stimulates neutrophil attraction, bringing neutrophil collagenase (MMP-8) to the irradiation site to further aggravate matrix degradation.8 In vitro inhibition of the NFκB pathway has been shown to reverse the downregulation of elastin and collagen expression caused by NFκB activation.9 For example, 4-Hexyl-1, 3-phenylenediol targets the NFκB pathway, slowing the aging process in the early stages and optimizing cell functions of renewal, regulation, and synthesis.10,11

The aging process, especially due to photodamage, is also believed to be at least partially because of the formation and activity of free radicals, also known as reactive oxygen species.12 The use of antioxidants is considered an effective

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