Evaluation of the Safety and Efficacy of a Non-contact Radiofrequency Device for the Improvement in Contour and Circumferential Reduction of the Inner and Outer Thigh
December 2015 | Volume 14 | Issue 12 | Original Article | 1422 | Copyright © December 2015
David McDaniel MDa and Petra Samková MDb
aMcDaniel Institute of Anti-Aging Research, Virginia Beach, VA
bPetra Clinic, Prague, Czech Republic
Abstract
BACKGROUND AND OBJECTIVE: When evaluating self-image, research confirms that the main focus of dissatisfaction for the majority of women is the size and shape of their bodies, particularly their hips, waist and thighs. The appearance of a woman’s thighs is often distanced from what she views as her ideal shape and size and is largely out of her control due to gender specific fat deposition. The issue of excessive subcutaneous fat deposits in the lateral thigh area is enhanced by the resistivity of local adipocytes to lipolysis. Subjects in this study underwent treatment of the bilateral inner and outer thighs using a non-contact field radiofrequency device (BTL Vanquish Flex Applicator, BTL Industries Inc., Boston, MA). The main objective of this study is to evaluate the safety and efficacy of the device for reducing the circumference of the inner and outer thighs as well as improving the overall contour of the treatment area.
MATERIALS AND METHODS: A total of 30 female subjects age 32 to 59 (average 42.4) were enrolled in the study. After meeting the inclusion/ exclusion criteria each subject received 4 weekly 30-minute bilateral thigh treatments (1 hour total treatment time). As the primary outcomes, circumferential reduction was measured and clinical before and after photographs were taken for assessment. Safety of the device was assessed by means of reported adverse events.
RESULTS: All 30 subjects completed the entire treatment series and 1 month follow-up visit. The average reduction measured on both thighs was 3.86 cm with statistical significance P< 0.05. There was no significant change in weight for any of the subjects. During the course of the study two adverse events occurred, but were deemed unrelated to the treatment.
CONCLUSIONS: Based on the measurements obtained the device under investigation was considered safe and effective in terms of improved contour and circumferential reduction of inner and outer thighs.
J Drugs Dermatol. 2015;14(12):1422-1424.
INTRODUCTION
Many women are very critical about the appearance of their bodies. Research confirms that the main focus of dissatisfaction for the majority of women is the size and shape of their hips, waist and thighs.1 For women, subcutaneous
fat deposits to these areas, specifically the lateral thighs (saddle bags), are more resistant to change, by traditional means of diet and exercise, than fat deposits in other areas of the body.2 This phenomenon is characterized by a higher level of estrogen production in women, which influences an increased number of α-2 adrenergic receptors on the surface of adipocytes in women’s hips and thighs. Presence of these α-2 adrenergic receptors inhibits the lipolytic process and has negative influence
on subcutaneous fat reduction.3 The role of hormones in gender specific fat deposition, from an evolutionary perspective, played a major role in increasing the chances of reproductive success. However, in modern times, with ample access to food and thus ample ability to sustain weight gain, women no longer need to have large fat stores to draw upon during childbearing years.4 What was once an evolutionary necessity is now the bane of many women’s existence. Since diet and exercise alone have
little impact, many seek surgery, such as traditional liposuction or non-invasive methods such as lasers, high intensity focused ultrasounds, cryolipolysis, and radiofrequencies.5,6
The device used in this study, BTL Vanquish, has been cleared by the United States Food and Drug Administration (FDA) as a noninvasive aesthetic treatment for the reduction of abdominal circumference. The device emits radiofrequency energy (RF), which when introduced to biological matter generates friction or movement of the atoms and molecules in response to the tissue's resistance (impedance) to an electric field. Tissue such as adipose tissue has greater resistance to the electric field than skin and muscle, thus resulting in a greater thermal effect in the targeted tissue.7
Two recently published studies have shown that the biochemical
mechanism of action of RF energy causes disruption of adipocyte cells via heat-induced apoptosis with subsequent cell collapse. This has been demonstrated in both the porcine and human model.8,9 In order to successfully induce apoptosis or
