A Randomized, Single-Blind, Postmarketing Study of Multiple Energy Levels of High-Intensity Focused Ultrasound for Noninvasive Body Sculpting

Authors


  • Drs. Solish and Kane received compensation from Medicis (Scottsdale, AZ) for conducting this study. Robert Axford-Gatley and Nicole M. Strangman are employees of Complete Healthcare Communications, Inc. (Chadds Ford, PA), which received compensation from Medicis for editorial assistance.

Address correspondence and reprint requests to: Nowell Solish, MD, FRCP (C), 66 Avenue Road, Suite 1, Toronto, ON M5R 3N8, Canada, or e-mail: n.solish@utoronto.ca

Abstract

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/cm2. 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; < .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/cm2: 17.1 mm, 95% CI = 4.33–29.81 mm; 52 J/cm2: 24.6 mm, 95% CI = 12.24–36.95 mm; 59 J/cm2: 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.

Ancillary