Participant Satisfaction, Effectiveness, and Safety With a Novel Dual-Applicator Cryolipolysis System: A Prospective, Multicountry Study.

BACKGROUND

Cryolipolysis is an effective, well-tolerated noninvasive subcutaneous fat reduction treatment.

OBJECTIVE

Assess participant satisfaction, effectiveness, and safety of a dual-applicator cryolipolysis system that can deliver simultaneous treatments.

MATERIALS AND

METHODS

Adult participants received treatment to the abdomen/flanks (midsection). Participants could also receive treatment to upper arms, thighs, and submental area. Primary end point was participant satisfaction with midsection results at 12 weeks after final treatment. Secondary end points included independent photography review, participant satisfaction with additional body areas, and overall satisfaction. Exploratory end points included 3D imaging of midsection volumetric changes and assessments at 4 weeks after initial treatment. Safety was monitored throughout.

RESULTS

Of 110 treated participants, 75% were female. Mean age and body mass index were 43 years and 25.1 kg/m 2 , respectively. Of 96 evaluable participants, 83.3% (80/96) were "satisfied/very satisfied" with midsection results. Reviewers correctly identified 88.0% (81/92) of baseline versus 12 weeks after final treatment midsection images. Mean (SD) subcutaneous fat volume loss was 194.8 (492.3) mL at 12 weeks after final treatment ( p < .001). Visible improvements were noted at 4 weeks after initial treatment by a majority of physician reviewers and participants. Five (4.5%, 5/110) participants reported 7 treatment-emergent adverse device effects.

CONCLUSION

The dual-applicator cryolipolysis system demonstrated high participant satisfaction, effectiveness, and safety.