A Double-Blind Randomized Controlled Trial Evaluating the Efficacy and Tolerability of a Topical Body Treatment in Combination With Cryolipolysis Procedures

April 2019 | Volume 18 | Issue 4 | Original Article | 342 | Copyright © April 2019

Alan D. Widgerow MBBCh MMed FCS(Plast) FACS,a Amir Moradi MD MBA,b Jeanette Poehler BA CRRCc

aDepartment of Plastic Surgery, University of California, Irvine, CA; Alastin Skincare, Inc., Carlsbad, CA bAmir Moradi MD, MBA, Private Practice, Moradi MD, Vista, CA cJeanette Poehler, BA, CCRC, Moradi MD, Vista, CA

Abstract

Background: Non-surgical fat reduction through cold application, cryolipolysis, is an extremely popular procedure. Apoptosis of the fat cell content may take around 3 months to resolve.

Objective: A topical test product was compared to a bland emollient as an adjunct to the cryolipolysis procedure of the upper arms to determine if the product could hasten outcomes in these patients. The product includes a peptide combination thought to stimulate autophagic breakdown of lipid droplets, thus speeding up the apoptotic process seen after cryolipolysis.

Methods: A randomized, double-blind, comparator-controlled study in 11 patients compared the test product to a bland emollient on the upper arms of patients following cryolipolysis. Subjects were followed at 1, 4, 8, 12, and some at 24-weeks post treatment. Assessments were made through subjective and objective photographic analysis of the treated areas comparing changes in both arms.

Results: The test product appeared to speed up the process of contour improvement with results at 8 weeks matching those attained at 12 weeks by the comparator and long-term results at 24 weeks appearing to maintain this advantage. When measured objectively using pixel analysis, 8 and 24-week contour improvement was statistically better than the comparator. Skin laxity was also improved. In additional assessments using 3D volume analysis, cases showed improved reduction of fat tissue on the treated sides.

Conclusion: This pilot study introduces a potential advance in adjuvant topical therapy aiding the outcome of non-invasive fat reduction procedures.

J Drugs Dermatol. 2019;18(4):342-348.

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INTRODUCTION

Non-invasive body contouring has become an extremely popular procedure in recent years. Devices involved utilize ‘hot” (radiofrequency/laser) or “cold” (cryolipolysis) technologies to achieve breakdown of fat tissue and elimination of the destroyed fat cells over a period of months. The mechanism of fat breakdown involved in cryolipolysis is thought to be through crystallization of the adipocytes and subsequent damage to the cell membrane, apoptosis, and extracellular leakage of lipid content, although this is still speculative.1,2 Absorption of the lipid droplet particles following adipose cell apoptosis can take months, delaying the outcome of the procedure and presenting an unknown risk of free fatty acids and triglycerides accumulating in the extracellular matrix prior to digestion.3 The aim of this study was to ascertain whether the topical application of a formulation purported to improve lipid droplet/debris elimination following cryolipolysis could accelerate this process and produce faster and/or enhanced results.

MATERIALS AND METHODS

A randomized, double-blind, comparator-controlled study was designed to assess the efficacy of a novel topical body treatment with TriHex and additional selected peptides (Alastin TransFORM Body Treatment with TriHex Technology®, Alastin Skincare, Inc., Carlsbad, CA) compared to a bland moisturizer, Cetaphil® lotion, (Galderma Laboratories, Fort Worth, TX) when undergoing cryolipolysis of the upper arm area.Eleven subjects were randomized to receive the topical body treatment with TriHex on one arm and the comparator (bland moisturizer) on the other arm. Eligible subjects were women between 25 and 65 years of age with clearly visible bilateral subcutaneous arm fat appearing as a distinct bulge of fat in the arm at least 14 cm from the elbow, with soft, pliable tissue of sufficient volume for treatment on both sides. Subjects with previous fat reduction procedures or implants in or near the treatment area, previous surgery in the arms, and any contra-indication to device usage, as determined by the physician relating to existing diseases or drug use were excluded from participating in the study. Subjects were instructed to avoid starting a major diet or exercise program and maintain a constant weight (within 5% of the baseline measure).Subjects underwent screening, baseline/treatment visit, and follow-up visits at 1, 4, 8, 12, and 24-weeks post treatment.