Selective Non-contact Field Radiofrequency Extended Treatment Protocol: Evaluation of Safety and Efficacy

September 2015 | Volume 14 | Issue 9 | Original Article | 982 | Copyright © 2015

Amir Moradi MDa and Melanie Palm MDb

aPrivate Practice, Vista, CA
bArt of Skin MD, Solana Beach, CA

Abstract

BACKGROUND AND OBJECTIVE: Currently there are many non-invasive radiofrequency (RF) devices on the market that are utilized in the field of aesthetic medicine. At this time, there is only one FDA cleared device on the market that emits RF energy using a non-contact delivery system for circumferential reduction by means of adipocyte disruption. Innovation of treatment protocols is an integral part of aesthetic device development. However, when protocol modifications are made it is important to look at the safety as well as the potential for improved efficacy before initiating change. The purpose of this study was to evaluate the safety and efficacy of a newly designed extended treatment protocol using an operator independent selective non-contact RF device for the improvement in the contour and circumferential reduction of the abdomen and flanks (love handles).
METHODS:Twenty-five subjects enrolled in the IRB approved multi-center study to receive four weekly 45-minute RF treatments to the abdomen and love handles. Standardized digital photographs and circumference measurements were taken at baseline and at the 1- and 3-month follow-up visits. Biometric measurements including weight, hydration and body fat were obtained at baseline and each study visit. A subset of 4 subjects were randomly selected to undergo baseline serum lipid and liver-related blood tests with follow-up labs taken: 1 day post-treatment 1, 1 day post-treatment 4, and at the 1- and 3-month follow-up visits.
RESULTS: Twenty-four subjects (22 female, 2 male), average age of 47.9 years (30-69 years), completed the study. The data of the twenty-four subjects revealed a statistically significant change in circumference P<.001 with an average decrease in circumference of 4.22cm at the 3-month follow-up visit. Lab values for the subset of 4 subjects remained relatively unchanged with only minor fluctuations noted in the serum lipid values in two of the subjects. Three independent evaluators viewed pre-treatment and 3-month post treatment photographs to determine which photo was the after photo. The evaluators were able to correctly identify the post treatment photos with an 88% accuracy rate. Treatments were well tolerated by all subjects. No study related adverse events were reported.
CONCLUSION: This study found that an extended treatment protocol using a selective RF device is a safe and effective method for the reduction of circumference and improved contouring of the abdomen and love handles.

J Drugs Dermatol. 2015;14(9):982-985.

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INTRODUCTION

A wide range of radiofrequency devices for nonsurgical aesthetic treatments is available on today’s market. However, they differ significantly in application, treatment time, efficacy, and patient safety. RF devices are commonly used to treat skin laxity, wrinkle reduction, cellulite, and body contouring.1 The demand for nonsurgical fat reduction has grown significantly over the past years. There are several fat reduction technologies on the market including lasers, high intensity focused ultrasounds, cryolipolysis, and radiofrequencies. 2

The number of fat cells (adipocytes) is the major determinant of fat mass in adults. Even after marked weight loss, the number of fat cells remains constant and only adipocyte volume is changed.3 Certain areas of the body tend to be more resistant in terms of volume reduction even with diet and exercise. A recent study showed that after 6 weeks of abdominal exercise training, there was no significant effect of abdominal exercises in reducing abdominal subcutaneous fat when compared to a control group in which no exercise was performed.4 These findings support the widely held notion that abdominal fat is one of the “stubborn” areas and resistant to change.

The induction of apoptosis has proven to be a viable means to effectively and permanently reduce adipose tissue. Apoptosis is a process of natural cell elimination necessary for maintaining body homeostasis. During this process, dangerous and/or unnecessary cells are removed.5,6 Apoptosis can be achieved when adipocytes are heated to a temperature range of 42-45C and this thermal threshold is maintained for a minimum of 15 minutes.7,8 The device under investigation (BTL Vanquish, BTL Industries Inc., Boston, MA) is proven to cause apoptosis in adipocyte tissue induced by selective RF field generated heat.9,10 The device is capable of reaching the desired treatment temperature (44-45C) in targeted subcutaneous adipose tissue within the first 15 minutes of the treatment and maintaining

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