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.
