Body Shaping and Skin Appearance Improvement in the Abdomen and Flanks by Radiofrequency Technology

This study aims to assess the safety and effectiveness of the Symmed radiofrequency (RF)-based device (Termosalud Inc., Gijón, Spain) in body contouring and skin appearance improvement treatments for abdomen/flanks.

Eight sessions of Symmed RF were performed in 15 volunteers' abdomen/flanks. Sessions were conducted every 72/96 h. To evaluate the efficacy and safety of the device, photographs, body contours, and ultrasound scans of dermal echogenicity, and adipose tissue thickness were taken at baseline and after the treatments. Additionally, a blind evaluation of the photographic results was conducted. Data regarding the satisfaction level of the participants was also obtained through a customized survey.

At the follow-up visit, significant reductions of 2% in body circumference and 9% in fat thickness were detected in the abdomen/flanks. These effects were accompanied by a significant 12% increase in dermal echogenicity, related to skin collagen content and organization. Furthermore, the blind evaluation of the photographic results revealed an overall visual improvement. A high satisfaction level was reported by the participants and no severe adverse events were detected.

Symmed treatment is a noninvasive procedure treating skin laxity and reducing abdomen/flanks circumferences safely and effectively.

This clinical trial is not registered in a publicly accessible database, and no clinical trial registration number is available. At the time of the investigation, the intended use for fat reduction through radiofrequency was not classified as a medical application under European legislation (COUNCIL DIRECTIVE 93/42/EEC). In accordance with Spanish and European regulations, only clinical trials evaluating medical devices are required to be registered.