Ji Yeon Hong1, Eun Jung Ko2, Sun Young Choi3, Tae-Rin Kwon1, Jong Hwan Kim1, Soo Yeon Kim4, Beom Joon Kim1. 1. Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea. 2. Department of Dermatology, National Police Hospital, Seoul, Korea. 3. Department of Dermatology, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea. 4. Clinical development team, Classys Inc., Seoul, Korea.
Abstract
BACKGROUND: Demand for noninvasive body contouring has increased. OBJECTIVE: We evaluated the efficacy and safety of a thermal high-intensity focused ultrasound (HIFU) device for abdominal body shaping. PATIENTS AND METHODS: Adults with a body mass index ≤30 kg/m and an abdominal subcutaneous fat tissue thickness ≥2.5 cm were enrolled for HIFU treatment at energy levels of 150 J/cm (first session) and 135 J/cm (second session). The primary end point was a change from baseline waist circumference at post-treatment Week 8. Secondary efficacy end points were: changes in body weight, waist/hip ratio, and fat thickness assessed by ultrasound, caliper, and a fat CT scan. The Global Aesthetic Improvement Scale was evaluated by both investigators and subjects. RESULTS: The primary assessment achieved statistical significance, showing a reduction of 3.43 cm in mean waist circumference. The treatment effect was cumulative, with a steady decrease in waist circumference and fat thickness. The mean pain scores immediately after treatment were 4.45 ± 2.74 on a scale of 1 to 10 with 10 being the most painful, which decreased to 1.10 ± 1.33 after 1 week. CONCLUSION: High-intensity focused ultrasound is an effective and safe treatment modality for reducing waist circumference in nonobese individuals with focal fat accumulation.
BACKGROUND: Demand for noninvasive body contouring has increased. OBJECTIVE: We evaluated the efficacy and safety of a thermal high-intensity focused ultrasound (HIFU) device for abdominal body shaping. PATIENTS AND METHODS: Adults with a body mass index ≤30 kg/m and an abdominal subcutaneous fat tissue thickness ≥2.5 cm were enrolled for HIFU treatment at energy levels of 150 J/cm (first session) and 135 J/cm (second session). The primary end point was a change from baseline waist circumference at post-treatment Week 8. Secondary efficacy end points were: changes in body weight, waist/hip ratio, and fat thickness assessed by ultrasound, caliper, and a fat CT scan. The Global Aesthetic Improvement Scale was evaluated by both investigators and subjects. RESULTS: The primary assessment achieved statistical significance, showing a reduction of 3.43 cm in mean waist circumference. The treatment effect was cumulative, with a steady decrease in waist circumference and fat thickness. The mean pain scores immediately after treatment were 4.45 ± 2.74 on a scale of 1 to 10 with 10 being the most painful, which decreased to 1.10 ± 1.33 after 1 week. CONCLUSION: High-intensity focused ultrasound is an effective and safe treatment modality for reducing waist circumference in nonobese individuals with focal fat accumulation.