A randomized, single-blind, postmarketing study of multiple energy levels of high-intensity focused ultrasound for noninvasive body sculpting.

BACKGROUND High-intensity focused ultrasound (HIFU) is a nonsurgical, noninvasive body sculpting method. OBJECTIVE To investigate preferences for treatment settings using a HIFU device. MATERIALS AND METHODS HIFU was applied to the anterior abdomen in three passes of decreasing depth (1.6, 1.3, and 1.1 cm) in patients randomized to HIFU energy levels (each of 3 passes [total]) of 47 (141), 52 (156), or 59 (177) J/cm(2). The primary assessment was week 12 post-treatment change from baseline waist circumference at the level of the iliac crest for all treatment groups combined. RESULTS The primary assessment achieved statistical significance (least squares mean 2.51 cm, 95% confidence interval [CI] = -3.14 to -1.88; p < .001), with no significant differences between groups. At week 12, 69% to 86% of patients and 73% to 79% of investigators rated appearance as improved or much improved. The average worst pain (100-mm visual analog scale) experienced during treatment was mild (47 J/cm(2): 17.1 mm, 95% CI = 4.33-29.81 mm; 52 J/cm(2): 24.6 mm, 95% CI = 12.24-36.95 mm; 59 J/cm(2): 30.9 mm, 95% CI = 18.71-43.17 mm). There were no serious adverse events. CONCLUSION HIFU treatment at different energy levels and multiple tissue depths was well tolerated and effective in reducing waist circumference.