A Multi‐Site, Single‐Blinded, Prospective Pilot Clinical Trial for Non‐Invasive Fat Reduction of the Abdomen and Flanks Using a Monopolar 2 MHz Radiofrequency Device
Michael Somenek, Stephen J. Ronan, Troy A. Pittman
Abstract
BACKGROUND AND OBJECTIVES: Demand for non-invasive body sculpting procedures has been steadily increasing, spurring the development of new energy-based technologies. This study assessed the safety and efficacy of a new monopolar 2 MHz radiofrequency (RF) device for fat reduction of the flanks and abdomen. STUDY DESIGN/MATERIALS AND METHODS: Nineteen subjects from two clinical sites were enrolled in this study and received a single 15-minute treatment with the 2 MHz RF device. Up to six applicators were placed on the abdomen and/or flanks during the treatment. Follow-up assessments were scheduled 12 weeks after treatment. Efficacy evaluations included live ratings and Global Aesthetic Improvement Scale (GAIS) ratings by blinded investigators, ultrasound measurements of fat thickness, and patient-reported outcomes before and after treatment. RESULTS: Investigator assessments showed more than one-point change in the GAIS scale at the 12-week follow-up visit. Ultrasound measurements revealed a significant reduction in fat thickness in both the abdomen (average 24%) and the flanks (22%). The majority of the patients were satisfied with the treatment and mild self-resolving side effects were observed. No serious adverse events were reported. CONCLUSIONS: Treatment of local adiposities with a new monopolar 2 MHz radiofrequency device leads to improvement of body contour with no downtime or side effects. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.