Prospective Multicenter Clinical Trial of a Temperature-Controlled Subcutaneous Microneedle Fractional Bipolar Radiofrequency System for the Treatment of Cellulite

BACKGROUND A bipolar fractional radiofrequency (RF) device was developed to generate cutaneous thermal injuries using a temperature-controlled microneedle electrode array. OBJECTIVE Evaluate safety and efficacy of a novel subcutaneous microneedle RF for treatment of posterolateral thigh cellulite. METHODS The study design was an institutional review board-approved multicenter clinical trial after a per-protocol analysis. Fifty subjects with Nurnberger–Muller Grade II or III cellulite were enrolled at 4 treatment centers and received 1 subcutaneous microneedle RF treatment (67°C/4-second duration). Efficacy was evaluated by blinded grading by 3 dermatologists using randomized, standardized photographs and investigator grading at baseline, 1-, 3-, and 6-month follow-up. As per the Food and Drug Administration, treatment success was defined by ≥1-point improvement on dimple number or severity of undulation irregularities scales by at least 2 of 3 blinded physicians. Study subjects' self-assessments and satisfaction questionnaires and procedural pain levels and adverse events were monitored. RESULTS Blinded physician evaluations revealed a procedural success rate of 93% at 6-month follow-up. Procedural pain level was 3.74 ± 1.96 on a 10-point scale. There were no adverse events. Seventy-five percent of subjects were satisfied with the results at 6-month follow-up. CONCLUSION The results indicate that subcutaneous microneedle RF treatment is safe and effective for long-term treatment of Type II and III cellulite in a single session. Address correspondence and reprint requests to: Macrene Alexiades, MD, PhD, 955 Park Avenue, New York, NY 10021, or e-mail: dralexiades@nyderm.org M. Alexiades, G. Munavalli, and D. Goldberg executed the study protocol, conducted the clinical study, and did not receive any compensation from Syneron Inc. Drs. Shlomit Mann and D. Berube are employed by Syneron Inc. Shlomit Mann performed data compilation and statistical analysis. M. Alexiades and D. Berube prepared the manuscript. © 2018 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.

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