Ultrasound Evaluation of a Single Treatment With a Temperature Controlled Multi-Frequency Monopolar Radio Frequency Device for the Improvement of Localized Adiposity on the Abdomen and Flanks

January 2020 | Volume 19 | Issue 1 | Original Article | 28 | Copyright © January 2020

Published online December 13, 2019

Amy Taub MD,a,b James Bartholomeusz BS bAppScb

aAdvanced Dermatology, LLC, Lincolnshire, IL and Glencoe, IL; Northwestern University Medical School, Chicago, IL bSkinQRI, Lincolnshire, IL

Abstract

BACKGROUND AND OBJECTIVES: Energy modalities used for fat reduction include cryotherapy, focused and unfocused ultrasound, radiofrequency, and laser. Two devices have been proven to reduce fat layer thickness using ultrasound as measurement after a single treatment. We hypothesized that a novel, high frequency monopolar radiofrequency device could increase the fat temperature enough to reduce its thickness as measured by ultrasound, without excessively increasing the temperature of the skin, leading to a safe, tolerable, and clinically relevant reduction of fat.

STUDY DESIGN/MATERIALS AND METHODS: A high frequency monopolar radiofrequency platform was used to treat twelve patients on the abdomen or flanks (truSculpt® 3D, Cutera, Brisbane, CA). Each patient received one treatment session, consisting of 15-minute increments for four areas (60 minutes total). Each area (approximately 144 cm2) was treated with a gliding handpiece technique to a skin temperature of 44-45˚C, correlating to in vivo measurements of the subcutaneous layer of >45˚C. Patients were evaluated at eight- and twelve-weeks following treatment. Clinical efficacy was measured using 360˚ positioned clinical photography. Fat layer reduction was measured with ultrasound. Safety was assessed by the treating physician; patient comfort was assessed during treatment via a 10-point pain scale.

RESULTS: All patients responded to treatment. Ultrasound measurements indicated mean fat layer reduction of 4.6 mm, which correlated with a 24% reduction in fat layer thickness at 12 weeks. A significant improvement was noted between the 8-week and the 12-week follow up. A high level of inter-patient consistency was achieved with most patients (10/12= 83%) having an average fat thickness reduction of >20%. No adverse events were observed, and pain scores during the treatment session ranged from 2 to 4 out of 10.

CONCLUSION: High frequency monopolar radiofrequency device produced consistent and statistically significant fat thickness reduction from a single 60-minute treatment session, with minimal discomfort and no demonstrated side effects. Results are comparable to other hypo- and hyper-thermic fat treatment technologies.

KEY WORDS: fat reduction, radiofrequency, monopolar RF, fat thickness reduction, body sculpting

J Drugs Dermatol. 2020;19(1):28-34. doi:10.36849/JDD.2020.4568

INTRODUCTION

Nearly 170,000 non-surgical fat reduction procedures, or body sculpting procedures, were performed in 2016, a 6% increase over the previous year. The popularity of these non-surgical procedures is growing rapidly, at approximately the rate of liposuction, which was the most popular aesthetic procedure in 2016 for both men and women, with an increase of 5% from 2015 to 2016.1 The 2016 American Society for Dermatologic Surgery survey of 7,322 consumers ranked body sculpting as the third most popular treatment in the US with 50 percent of respondents considering the procedure.2 Various energy modalities are being used for non-surgical fat reduction including cryotherapy, focused and unfocused ultrasound, radiofrequency (RF), and laser.3 Non-invasive RF technology has a unique advantage of selectively heating relatively large volumes of subcutaneous adipose tissue.4 The biophysics of how this technology achieves this effect has been explained in detail by Franco et al.4,5 The heat induced by RF energy is transferred from the electric field causing movement of atoms in the tissue, resulting in friction and collision of the tissue molecules. The RF devices employed for aesthetic