A multicenter controlled study to evaluate multiple treatments with nonthermal focused ultrasound for noninvasive fat reduction
Reference:Coleman WP 3rd, Coleman W 4th, Weiss RA, et al. Dermatol Surg. 2017 Jan;43(1):50-57.
Study Details:
- 150 subjects (19 males and 131 females; mean age 45 years; mean BMI 25.5±2.3) with Fitzpatrick skin types I to VI were randomly assigned to Group 1 (n=118) for a 4-week control phase before undergoing abdominal fat reduction treatments or to Group 2 (n=32) for immediate treatment
- 3 UltraShape treatments with large transducer at 2-week intervals
Study Results:
- Weight remained stable in the 126 participants who completed 3 treatments and follow-ups
- Mean midline abdominal circumference reduction of 2.5 ± 2.1 cm in Group 1
- Mean midline abdominal circumference reduction of 3.5 ± 2.7 cm in Group 2
- No statistically significant covariate effects of gender, race, skin type, BMI, and abdominal fat thickness on midline circumference reduction
- No statistically significant difference between study population (USA participants vs. non-USA participants)
- Mild and transient erythema was observed in 28% of treatments