Single Treatment of Grades II and III Cellulite Using a Minimally Invasive 1,440-nm Pulsed Nd:YAG Laser and Side-Firing Fiber: An Institutional Review Board-Approved Study with a 24-Month Follow-Up Period

Abstract

Cellulite represents one of the common topographic alterations to the skin surface and one of the structural changes to the subdermal fat and septal band of the posterolateral thighs. Currently, no treatment exists to address this entity with a multifactorial genesis that produces long-term beneficial outcomes. This clinical study evaluated the safety and efficacy of the 1,440-nm laser and the duration of the clinical benefits during 2 years. Initially, 25 healthy women with thigh cellulite were enrolled in this prospective institutional review board (IRB)-approved study. For grade II cellulite, the laser fiber delivered up to 1,000 J of energy to the undersurface of the entire involved skin. For grade III cellulite, the laser fiber distributed 1,300 to 1,500 J of energy to melt the subdermal fat, subcise the taut septal bands, and heat the reticular dermis. Baseline and posttreatment analyses included standardized high-resolution photography, skin elasticity measurements, ultrasound scanning for dermal thickness, histology, investigator global assessment scores, and recording of adverse events. Of the 24 subjects who underwent treatment, only 20 were available for the 6-month follow-up assessment. Objective measurements at 2 years demonstrated an increase over the baseline mean skin elasticity (34 %) and mean dermal thickness (11 %), as well as an increase in the average percentage of dermal thickening determined by ultrasound imaging. Independent investigator global assessments were rated higher for grade II subjects than for grade III subjects throughout the 2-year follow-up period. Mild adverse events disappeared by the third month. This IRB-conducted clinical trial, as part of a multicenter study for Food and Drug Administration approval, demonstrated the safety and efficacy of a single minimally invasive treatment for grades II and III thigh cellulite during a 2-year follow-up period. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .