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

ABSTRACT

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.