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

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 followup 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.

Combination of monopolar 2 MHz radiofrequency and electrical multidirectional stimulation for reducing abdominal circumference and enhancing the muscle definition in subjects with overweight range body mass index

“…A recent trial evaluated the effect of the same monopolar 2 MHz RF device used in this study for adipose tissue reduction in the abdomen and flanks. Using a single 15‐minute RF treatment to the target areas, a significant fat thickness reduction was achieved (24% in the abdomen, 22% in the flanks) at 12 weeks via ultrasound measurement 3 . This is congruent with the findings of this study, wherein a reduction in both AC and skinfold thickness up to 2 months was seen after a single RF session followed by six EMDS treatments.…”

“…When used appropriately, noninvasive devices demonstrate significant clinical efficacy. However, these technologies also exhibit certain limitations and are generally reserved for patients with low BMI and limited areas of adiposity 2,3 …”

“…In monopolar devices, RF waves are passed from a single electrode through the skin and subcutaneous tissue toward a return pad, whereas in bipolar or multipolar RF devices, the energy passes between electrodes within the same handpiece 22–25 . Because of this configuration, energy from a monopolar device is able to penetrate deeper into tissues 3,26,27 …”

“…Previously, surgical intervention through liposuction or abdominoplasties were the mainstay interventions for this problem. However, because of associated surgical risks and significant downtime, the demand has shifted toward effective, noninvasive body contouring options 1–3 …”

“…These devices emit RF energy waves that provide selective volumetric heating of the mid‐dermis up to the subcutaneous tissue layer. This results in both collagen stimulation in the dermis for skin tightening and adipocyte damage in the subcutaneous layer for fat reduction 3 …”