Abstract:Cryolipolysis is worthy of further study because it has been shown to significantly decrease subcutaneous fat and change body contour without causing damage to the overlying skin and surrounding structures or deleterious changes in blood lipids.
“…Findings This nonrandomized interventional cohort study showed that bilateral submental cryolipolysis treatment of 14 participants resulted in a statistically significant reduction in fat thickness (3.77 mm) and skin surface area (1.29 cm 2 ) and yielded high participant satisfaction (93%). Side effects of the procedure were typically mild and included numbness and tingling, which resolved without intervention.…”
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 PARTICIPANTSThe 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 MEASURESParticipant 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) cm 3 (from a reduction of 32.69 cm 3 to an increase of 13.85 cm 3 ), in skin surface area of 1.29 (1.42) cm 2 (from a reduction of 3.18 cm 2 to an increase of 0.99 cm 2 ), 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 RELEVANCEAlthough 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.
“…Findings This nonrandomized interventional cohort study showed that bilateral submental cryolipolysis treatment of 14 participants resulted in a statistically significant reduction in fat thickness (3.77 mm) and skin surface area (1.29 cm 2 ) and yielded high participant satisfaction (93%). Side effects of the procedure were typically mild and included numbness and tingling, which resolved without intervention.…”
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 PARTICIPANTSThe 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 MEASURESParticipant 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) cm 3 (from a reduction of 32.69 cm 3 to an increase of 13.85 cm 3 ), in skin surface area of 1.29 (1.42) cm 2 (from a reduction of 3.18 cm 2 to an increase of 0.99 cm 2 ), 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 RELEVANCEAlthough 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.
“…Clinical studies have been performed to characterize any potential effects on the blood lipid profile, and they have documented that cryolipolysis appears to have no significant impact. In the initial preclinical animal studies, no significant changes in the blood lipid or liver profile were observed following multiple cryolipolysis treatments of large body surface areas [14]. Human clinical studies have also shown no significant changes in lipid profiles or liver function tests following cryolipolysis.…”
Section: Complications: How To Avoid Them and How To Treat Themmentioning
“…Cryolipolysis is a new method of non-invasive fat layer reduction, which has been shown to significantly reduce fat layer thickness without damage to the skin or other surrounding tissues [1,2]. Adipocytes suffer a fatal apoptotic injury when exposed to cold, as demonstrated by studies on cultured samples [3].…”
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