A Clinical Evaluation of a Next Generation, Non-Invasive, Selective Radiofrequency, Hands-Free, Body-Shaping Device
December 2016 | Volume 15 | Issue 12 | Original Article | 1557 | Copyright © December 2016
Nicole Hayre MD,a Melanie Palm MD,b and Peter Jenkin MDc
aCosmetic Dermatology Center, McLean,VA bArt of Skin, MD, Solana Beach, CA cDermatology Associates, Seattle,WA
Abstract
OBJECTIVE: The aim of this study was to compare clinical outcomes of a noninvasive selective radiofrequency (RF) eld device (BTL Vanquish METM, BTL Industries Inc., Boston MA) with its predecessor (VanquishTM, BTL Industries Inc., Boston MA). The BTL Vanquish METM system has been thoroughly redesigned for more efficient, predictable and homogenous energy delivery to the targeted tissue.
MATERIALS AND METHODS: In this multi-center study, 36 subjects with BMIs under 30 were randomly assigned to be treated in Group A (BTL Vanquish METM) or Group B (VanquishTM) in order to obtain a side by side comparison of the devices’ ef cacies. Each subject re- ceived 4 weekly 45-minute treatments with the device determined by their group assignments. Measurements of subject’s abdominal fat were taken prior to the first treatment and again four weeks after finishing the final treatment.
RESULTS: The primary outcome was abdominal fat thickness reduction as measured by ultrasound one month following each subject’s final treatment. Thirty four subjects completed the study. Two patients did not complete their treatments due to the reasons unrelated to the study (one from each group). Subjects in Group A treated with BTL Vanquish METM had an abdominal fat thickness reduction of 4.17 mm, or 29.46%, while subjects in Group B treated with VanquishTM had an abdominal fat thickness reduction of only 2.72 mm, or 15.21%. The 4 weekly treatments with BTL Vanquish METM in Group A produced a 53% higher reduction (4.17 mm vs 2.72 mm) of abdominal fat layer thickness than those in Group B. The standard deviation of ultrasound measurements in Groups A and B were 1.42mm and 2.21mm, respectively.
Assuming a homogenous response across the entire treatment area, the volume of fat reduced was calculated by multiplying the average measured reduction in fat layer by the surface area of the treatment applicator (2100 cm2; 325.5 square inches). It was calculated that Group A patients lost an average of 0.876 liter (0.23 liquid gallon) of fat, while Group B patients lost 0.571 liter (0.15 liquid gallon) of fat.
DISCUSSIONS AND CONCLUSIONS: The mean difference between the tested groups was statistically significant proving better outcomes in the Vanquish METM than its predecessor. Furthermore, the reduction in standard deviation of fat reduction measurements in Group A vs Group B is evidence that the Vanquish METM provides more consistent performance.
J Drugs Dermatol. 2016;15(12):1557-1561.
INTRODUCTION
Radiofrequency energy generates electric current which irradiates the targeted tissue. When this electric current meets resistance in the tissue, it produces heat. It is the heat generated which induces the desired changes in the body. This method has emerged as an effective, noninvasive, aesthetic treatment modality for body contouring and fat reduction. The medical use of RF is based on an oscillating electrical field that forces collisions between charged molecules and ions, causing molecular friction, which is then transformed into heat. Selective RF technology allows for noninvasive and preferential heating of large volumes of subcutaneous adipose tissue. By choosing the electric field’s conductivity and relative permittivity, it is possible to selectively achieve greater heating of fat. Under normal conditions, the orientation of dipoles in the adipose tissue is random. Polarization forces these dipoles to rotate and orientate in one direction. Dielectric polarization induces each electrical dipole to rotate against the polarization of the electrical field. With a rapidly alternating electromagnetic field, the electrical dipoles oscillate back and forth, creating molecular friction. This causes the fatty tissue to heat up, which is the principle mechanism of action of selective RF fields on fat. The contactless selective radiofrequency device is designed to deliver noncontact transcutaneous selective RF, generate heat specifically in subcutaneous adipose tissue, and to induce adipocyte apoptosis with only minimal effect on skin and muscle. Muscle and skin have different conductivity and relative permittivity than fat; water in skin contributes to its low impedance while subcutaneous adipose tissue has high impedance. The applicator-generator circuitry is engineered to selectively deliver the energy to the adipose tissue layer. The contactless selective
