Restoration of Aging Body Skin: Evidence-Based Development of a Topical Formulation for Improving Body Skin Quality

September 2023 | Volume 22 | Issue 9 | 887 | Copyright © September 2023


Published online August 28, 2023

doi:10.36849/JDD.7292

Elizabeth T. Makino BS CCRA MBAa, Lily I. Jiang PhDb, Summer F. Acevedo PhDb, Audrey Nguyen BSa, Tsing Cheng PhDa, Kuniko Kadoya PhDa, Rahul C. Mehta PhDa

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

Abstract
Background: Age-related changes in body skin are emerging as important therapeutic targets. A novel topical firming and toning body lotion (FTB) has been developed to target multiple pathways involved in body skin rejuvenation.
Methods: FTB was evaluated in a randomized, double-blind, vehicle-controlled, 12-week study in women (N=54) with mild to moderate lack of firmness on the upper arms and mild to moderate cellulite on the thighs. Investigator clinical assessments, instrumentation evaluations, and patient questionnaires were performed. Histological assessment of ex vivo human skin treated with FTB and gene expression analysis in 3-dimensional human skin models following application of FTB or product comparators were conducted.
Results: At week 12, FTB treatment significantly improved (vs baseline) firmness, sagging, smoothness, texture, cellulite, and crepiness on investigator-, instrument-, and photographically assessed outcomes. Participants reported significant improvements in self-perceived efficacy and overall satisfaction with the appearance of their skin following FTB treatment vs vehicle control. Adverse events were mild or moderate in severity. FTB supported new collagen and elastic fiber formation in ex vivo skin. FTB increased skin rejuvenation–associated gene expression vs comparator products.
Conclusions: FTB provided significant improvements in the upper arms and thighs compared with baseline and vehicle control across multiple investigator and instrumentation evaluations. Most participants reported greater efficacy and treatment satisfaction with FTB vs vehicle. FTB treatment stimulated dermal extracellular matrix renewal and induced expression of genes involved in skin rejuvenation pathways. This study provides clinical and preclinical evidence supporting the use of FTB to improve body skin quality. 

Citation: Makino ET, Jiang LI, Acevedo SF, et al. Restoration of aging body skin: evidence-based development of a topical formulation for improving body skin quality. J Drugs Dermatol. 2023;22(9):887-897. doi:10.36849/JDD.7292

INTRODUCTION

A large proportion of research and clinical attention in aesthetic medicine is devoted to the restoration and repair of age-related changes in the skin. In recent years, these efforts have increasingly expanded into the care of body skin, broadening the field's historical near-exclusive focus on the face and décolletage.1 The increased interest in and use of minimally invasive body sculpting techniques, in which directed energy is used for the reduction of adipose tissue, may be partially responsible for this wider focus.2

Intrinsic age-related changes characteristic of body skin include loss of extracellular matrix (ECM) proteins, increased stratum corneum thickness, and reduction and redistribution of subcutaneous fat deposits.1,3 Although these genetically and physiologically driven changes are observed throughout the body surface with increased age, their severity, age of onset, and rate of progression vary substantially from site to site.3 

The predominant extrinsic factor in skin aging is exposure to ultraviolet (UV) light, with tobacco use and environmental toxins (eg, air pollution) also playing significant roles.4 

Much of the therapeutic attention to aging body skin centers on 3 specific skin quality issues: sagging (laxity), primarily driven by fat redistribution and loss of ECM integrity3,5; crepiness (fine wrinkling), driven by UV light and toxin exposure and laxity; and cellulite (gynoid lipodystrophy), driven by fat protrusion through the ECM and exacerbated by fluid accumulation and laxity.6-8 
 
Our evidence-based approach to the development of topical products designed to improve age-related changes in skin quality is based on the identification of biological pathways contributing to specific skin attributes.1,8,9 We have evaluated and selected bioactive botanicals capable of modulating specific 
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