Noninvasive fat reduction is claimed by many device manufacturers, but proof of efficacy has been difficult to establish. This prospective study was designed to measure the reduction of fat thickness and actual volume reduction in 20 female patients treated with an external radiofrequency (RF) device. This device combines RF heat, suction coupled vacuum, and oscillating electrical pulses that induce adipocyte death over time. Patients underwent pre- and post-treatment and intercurrent measurements of weight, body mass index, ultrasonic transcutaneous fat thickness, and 2D and 3D Vectra photography with independent calculation of circumferential and volumetric change. Mean transcutaneous ultrasound thickness at reproducible points was 2.78 cm; at 1-month post-treatment, the mean fat thickness was 1.71 cm. At 3-month post-treatment, the mean fat thickness reduction was 39.6%. Vectra circumference measurements were taken at 10-mm intervals, with postural and breathing cycle control. Independent analysis of serial measurements from + 60 to − 70 mm showed mean abdominal circumference measurement of 2.3 cm. Mean abdominal volume loss was 202.4 and 428.5 cc at 1- and 3-month post-treatment, respectively. Scanning electron microscopy confirmed that permanent cell destruction was caused by irreversible electroporation. Pyroptosis appears to be the mechanism of action.
To date, there have been no objective measurements of subcutaneous volume loss following treatments with a noninvasive radiofrequency (RF)-based device. Twenty female patients were treated with a suction-coupled bipolar RF device using external RF energy combined with pulsed electromagnetic RF energy for subcutaneous fat reduction. Parameters followed included weight, Vectra measurements of abdominal circumference and torso volume, and high-definition ultrasound measurements of fat thickness. Measurements were taken before treatment and three times following treatment. Analysis of the measured parameters showed that mean circumference reduction of 2.30 cm was noted at three months post-treatment. Independent volumetric analysis showed a mean subcutaneous volume reduction of 428 cc three months following RF treatment. High-resolution ultrasound fat thickness was reduced by a mean of 39.6% three months following the final BodyFX treatment. Independent and paired-sample t-tests showed a p value of < 0.05. Repeated measures of analysis of covariance (ANCOVA) adjusted for differences in age, as well as height and weight (proxy for body mass index) to minimize individual differences and control for extraneous variables that may affect the pre- and post-treatment results were analyzed. No confounding variables were found. All analyses were conducted using IBM SPSS 21.0.
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