Safety, Effectiveness, and Participant Satisfaction With Multiple Simultaneous Cryolipolysis Treatments Using a Dual-Applicator Cryolipolysis System.

Abstract

Background: Cryolipolysis is a safe, effective, and noninvasive treatment for subcutaneous fat reduction.

Objective: Assess safety, effectiveness, and participant satisfaction with multiple simultaneous dual-applicator cryolipolysis treatments on the torso.

Materials and methods: Adult participants received multiple simultaneous treatments to the torso (i.e., flanks, abdomen, back/bra area). Primary effectiveness end point was ≥70% correct identification of baseline versus week 12 post-final treatment photographs by ≥2 of 3 independent reviewers; safety end point was frequency of adverse device effects (ADEs). Secondary end points included fat layer thickness reduction and participant satisfaction/comfort.

Results: Mean participant age (N = 35) was 40.4 years, 77.1% were female, and mean body mass index was 24.9 kg/m2. A mean of 20.8 treatment cycles were received over 2 treatment sessions. The primary effectiveness end point was met; 75% of pretreatment images were correctly identified. Mean reduction in fat layer thickness was 0.33 cm. Most ADEs were mild, with no serious events. Mean overall participant satisfaction with the procedure was 82.8%. Mean maximum pain scores were 2.6 and 4.1 (scale of 10) during treatment sessions 1 and 2, respectively.

Conclusion: Multiple simultaneous cryolipolysis treatments on the torso using a dual-applicator system were safe and effective, with high overall participant satisfaction.