A randomized, controlled multicenter study evaluating focused ultrasound treatment for fat reduction in the flanks

Reference: Gold MH, Coleman WP 4th, Coleman WC 3rd, Weiss R. J Cosmet Laser Ther. 2018 Mar 13:1-5.

Study Details:

• 46 subjects (8 males, 38 females), with mean age 45 ± 10 years, Fitzpatrick Skin Types II–V and body mass index 25 ± 2 (range 22-29)
• 3 biweekly UltraShape treatments with small 12-gram transducer (USculpt) to unilateral flank (control flank untreated) with mean focal treatment zones (FTZ) of 2.7 ± 1 (range 1 to 6)
• 2 blinded dermatologists reviewed the randomized digital clinical images (baseline, 16-week follow-up) for identification of baseline vs. treated & treated vs. untreated
• Skin caliper and ultrasound measurements post-treatment compared to baseline

Study Results:

• 93% (42/45) of treated flanks vs control flanks correctly identified
• 82% (37/45) of post-treatment images vs pre-treatment images correctly identified
•  All study subjects demonstrated significant fat reduction in their treated area, as compared to untreated flanks (p<0.001) measured by ultrasound and skin caliper
• Little or no discomfort, mean pain level of 0.38 ± 0.84 (scale of 0=no pain to 10) 
• Transient erythema and edema associated with treatment, resolving within several days