Efficacy and Tolerability of a Novel Topical Treatment for Neck: A Randomized, Double-blind, Regimen-Controlled Study

February 2021 | Volume 20 | Issue 2 | Original Article | 184 | Copyright © February 2021


Published online January 19, 2021

Elizabeth T Makino BS CCRA MBAa, Kuniko Kadoya PhDa, Robin Chung MSa, Lily Jiang PhDb, Mouna Mikati PhDa, Rahul C Mehta PhDa

aSkinMedica - Allergan Aesthetics, an AbbVie Company, Irvine, CA
bSGS Stephens Inc., Richardson,TX

Abstract
The neck plays a telling role as an age indicator. Due to its anatomy and function, neck skin ages differently than facial skin and special considerations need to be taken when providing treatment. A randomized, double-blind, regimen-controlled study was conducted to assess the efficacy and tolerability of a novel topical cosmetic cream (NCC) specifically tailored to address the signs of skin aging of the neck and décolletage. Twice daily application of NCC significantly improved skin sagging/laxity of the neck as well as the appearance of fine and coarse lines/wrinkles, crepiness, tactile roughness, overall skin texture, hyperpigmentation, skin tone evenness, and radiance. NCC also significantly improved the appearance of fine and coarse lines/wrinkles, tactile roughness, hyperpigmentation, skin tone evenness, and radiance of the décolletage. Investigator assessments were corroborated by objective cutometer measurements that demonstrated improved skin firmness and elasticity. In vitro analysis in human 3D skin models show that stimulation of neocollagenesis and neoelastogenesis as well as support of cellular proteostasis through proteasome and autophagy activation are potential mechanisms of action for the observed clinical outcomes.

J Drugs Dermatol. 20(2):184-191. doi:10.36849/JDD.2021.5819

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INTRODUCTION

The face is the primary concern for most patients seeking skin rejuvenation treatments; however, consumer focus is starting to include other body parts, including neck and décolletage. During the aging process, the neck experiences several anatomical changes including loss of elasticity, platysmal banding, and fat accumulation.1 As the most superficial layer of the neck, the skin bears the cumulative burden of years of sun exposure resulting in loss of elasticity and firmness and the appearance of horizontal skin rhytides due to degeneration of dermal collagen and elastic fibers. Exposure to UVA/UVB rays and other environmental aggressors further causes hyperpigmentation, redness, and a telangiectatic mat referred to as poikiloderma of Civatte.2,3 Typical aesthetic concerns of the décolletage include appearance of uneven skin tone, hyperpigmentation, and rough skin texture.

Neck skin is more flexible and extensible than facial skin to allow for head movements, experiences greater loss in elasticity with aging, and is more damage-prone as it is thinner and more delicate. Due to lower sebum secretion, neck skin shows more severe aging patterns and deeper wrinkles than facial skin. Furthermore, neck skin has fewer appendages, which can delay post-procedural healing and outcome.4-7 A topical cream that provides clinically proven skin rejuvenation benefits could offer patients a reliable treatment option prior to or in combination with procedural modalities.

Understanding the key factors implicated in neck skin aging was crucial in formulating the novel topical neck cosmetic cream (NCC) described in the current study, allowing for a rational combination of ingredients designed to improve the signs of aging specific to skin of the neck and décolletage. Ingredients include shiitake mushroom extract and peptides to support extracellular matrix (ECM) quality and structure, Japanese lemon balm to enhance autophagy and promote collagen remodeling, rice extract to activate the proteasome system and maintain proteostasis, paracress extract to reduce muscle micro-contractions and support platysma muscle rejuvenation, and various potent antioxidants, including Dunaliella salina and Physalis angulata, to protect against environmental aggressors and reduce oxidative stress-induced damage.

MATERIALS AND METHODS

Human 3D Skin Model
In vitro studies were conducted using the EpiDermFTTM 3D full thickness human skin model (EFT-400, MatTek Corp). Tissues were cultured with EpiDermFT Assay Media (EFT-400- MM, MatTek Corp). EpiDermFT was irradiated with 200mJ/cm2 ultraviolet (UV) light using UV-B filter UV lamp (Honle, Germany) to indicate an extrinsic aging model, followed by topical application of 25 μL of test product or dH2O (control), and incubated at 37oC and 5% CO2 for 24 hours. After incubation, five tissues of each condition were placed into RNAlater® solution (ThermoFisher Scientific).