A Focused Monopolar Radiofrequency Causes Apoptosis: A Porcine Model
November 2014 | Volume 13 | Issue 11 | Original Article | 1336 | Copyright © 2014
David McDaniel MD,a Klaus Fritz, MD,b,c Alena Machovcova MD PhD MBA,d,e and Jan Bernardy PhDf
aMcDaniel Institute of Anti-Aging Research, Virginia Beach, VA
bDermatology and Laser Centers Landau, Germany
cUniversity of Osnabrück – Department of Health Sciences
dUniversity Hospital Motol, Department of Dermatology and Venereology, Prague, Czech Republic
eDepartment of Occupational Medicine, 1st Faculty of Medicine at Charles University, Prague, Czech Republic
fVeterinary Research Institute, Brno, Czech Republic
BACKGROUND: The purpose of this study was to demonstrate the effect of monopolar, focused radiofrequency (RF) with embedded cooling on subcutaneous skin structures. Specifically, the study was to prove that the monopolar RF with cooling can selectively heat fat, causing disintegration of adipocytes and programmed cell death (apoptosis) of the subcutaneous fat cells.
METHODS: A non-invasive monopolar RF device with cooling (Exilis Elite, BTL Industries, Framingham, MA) was used to reduce abdominal fat in a porcine model. The study was done on 3 Vietnamese pigs in a certified veterinary facility. The treatment was delivered to an area the size of 20 x 10cm. The treatment duration was 11 minutes, 30 seconds. Biopsy samples were taken before the first treatment, 1 hour post each treatment, as well as 8 and 20 hours post each treatment. Programmed cell death (apoptosis) was monitored using the TUNEL method. The temperature was measured on the skin surface by an infrared thermal imager and built-in IR thermometer, and by an internal probe inserted into various depths of the subcutaneous layer. The internal probe placement was monitored by diagnostic ultrasound examination.
RESULTS: The temperature in the treated adipose tissue was higher compared to the skin surface temperature. The average temperature gradient observed was 3.1°C. Due to the temperature gradient the skin surface remained intact, while subcutaneous layers showed significant changes. The TUNEL method proved large-scale apoptosis of fat cells after each treatment. The apoptotic index increased from 7% before the first treatment to an average of 53.4%, 39.6%, 40.2%, and 44.7% respectively for each treatment. In the three-month follow up the apoptotic index dropped back to 11.7%. Histology, blood biochemistry and hematology samples showed mild to no signs of inflammation in the treated area.
CONCLUSION: The study has shown that use of monopolar, focused radiofrequency can induce substantial apoptotic process in a porcine model. The data suggests that the monopolar, focused radiofrequency device can be used for reduction of fat and body shaping.
J Drugs Dermatol. 2014;13(11):1336-1340.
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The demand for safe and effective devices for non-invasive body shaping and reduction of fat has steadily risen over the last decade. Many modalities have been developed to target adipocytes, including ultrasound, radiofrequency, and various cooling and light based devices.1,2,5
In this study, we evaluated the ability of a monopolar focused radiofrequency device to induce apoptosis in the subcutaneous fat. The device delivers uniform heating at controlled depths to the subcutaneous tissue, due to its adjustable built-in cooling system. The clinical efficacy was intended to safely and efficiently deliver maximum power and speed of high frequency radio waves using an active cascade of hardware and software safety elements.
This study was carried out in a veterinary and a laboratory certified to Good Laboratory Practices (GLP) standards. Animal care was in compliance with the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, and with the law on the Protection of Animals Against Cruelty. The protocol of the study was approved by the Institutional Animal Care and Use Committee (IACUC) and the Committee for Animal Protection of the Ministry of Agriculture of the Czech Republic. Procedures used conformed to accepted practices and to minimize or avoid causing pain, distress, or discomfort to the animals. In those circumstances in which study procedures were likely to cause more than momentary or slight pain or distress, the animals received appropriate analgesics or anesthetics. During anesthesia the life functions and pain perception of treated animals were monitored to assure full insensibility during painful treatment and correct recovery. The number of animals selected for use in this study was considered to be the minimum (OECD Principles) number necessary to meet scientific and regulatory guidelines for this type of study.