Safety and Efficacy of Bilateral Submental Cryolipolysis With Quantified 3-Dimensional Imaging of Fat Reduction and Skin Tightening.

Importance Cryolipolysis is a popular, well-tolerated nonsurgical procedure that uses controlled cooling to selectively destroy fat cells. Central submental cryolipolysis has been reported to be safe and effective, but many patients would benefit from extending this treatment over the entire submental region. Objective To investigate the safety and efficacy of cryolipolysis for reduction of lateral and central submental fat. Design, Setting, and Participants The study population consisted of 14 participants who were treated from January 22 to June 30, 2016, in the lateral and central submental area to reduce unwanted subcutaneous fat. A small-volume cup applicator was used to administer 2 cryolipolysis treatments, delivered in 45-minute treatment cycles in 2 sessions. For the first treatment session, all participants received bilateral treatments with approximately 20% overlap of the treatment area. At the 6-week follow-up visit, participants were reassessed to determine whether they would benefit from a second treatment and to determine the number of cycles needed to achieve the optimal aesthetic result, and then they were treated a second time. Main Outcomes and Measures Participant surveys assessed tolerability and treatment satisfaction at 12 weeks following the second treatment. Clinicians monitored adverse events to assess safety. Caliper measurements were recorded to assess fat thickness reduction. Treatment efficacy was objectively evaluated using 2-dimensional and 3-dimensional imaging. Results Among the 14 participants (12 women and 2 men; mean [SD] age, 50.5 [10.4] years), the adverse effects of the procedure were typically mild and included numbness and tingling, which resolved without intervention by the final 12-week follow-up visit. An independent review of digital photographs revealed an 81.0% (95% CI, 65.9%-91.4%; P = .02) correct identification rate (34 of 42 images) of the pretreatment and posttreatment images. Caliper measurements demonstrated a mean (SD) fat layer reduction of 2.3 (0.8) mm (range, 0.7-3.5 mm). Three-dimensional imaging revealed a mean (SD) reduction in fat volume of 4.82 (11.42) cm3 (from a reduction of 32.69 cm3 to an increase of 13.85 cm3), in skin surface area of 1.29 (1.42) cm2 (from a reduction of 3.18 cm2 to an increase of 0.99 cm2), and in fat thickness of 3.77 (3.59) mm (from of reduction of 13.10 mm to an increase of 0.47 mm). Results of participant surveys indicated that 13 participants (93%) were satisfied with the cryolipolysis treatment. Conclusions and Relevance Although safe and efficacious central submental cryolipolysis has been reported, this is the first clinical study of cryolipolysis for treatment of the entire submental area using overlapping bilateral treatments and a shorter treatment duration. The study demonstrates that bilateral submental cryolipolysis is well tolerated and produces visible and significant fat layer reduction. Level of Evidence 4.