Efficacy and safety of non-invasive body tightening with high-intensity focused ultrasound (HIFU)

Abstract Background Noninvasive skin‐tightening devices have become increasingly popular in response to increasing demand for improvements in skin laxity and tightening with minimal risk and recovery time. Objective We evaluated the efficacy and safety of HIFU for skin tightening in the face and body. Methods A total of 32 Korean subjects enrolled in this prospective clinical trial. The subjects were treated with HIFU to both cheeks, lower abdomen, and thigh. Skin elasticity was measured before and after treatment using a Cutometer (CT575, Courage and Khazaka ® , Cologne, Germany). Three blinded, experienced dermatologists evaluated paired pre‐ and post‐treatment (week 4 and 12) photographs according to the Global Aesthetic Improvement Scale (GAIS). Participants also completed self‐assessments using GAIS. Subjects rated their pain on a numeric rating scale (NRS) immediately, 7 days, 4 weeks, and 12 weeks after treatment. Results Skin elasticity measured via a Cutometer was significantly improved 12 weeks after treatment at all treated sites ( P <.05). Both IGAIS and SGAIS showed significant improvements 12 weeks after treatment. Immediately after treatment the mean NRS score was 3.00±1.586, but no pain was reported at 4 and 12 weeks post‐treatment. No serious adverse effects were observed during the follow‐up period. Conclusion HIFU safely and effectively improves skin elasticity and clinical contouring of the face and body.