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Safety and efficacy of bilateral submental cryolipolysis with quantified 3-dimensional imaging of fat reduction and skin tightening

JAMA Facial Plastic Surgery Nov 03, 2017

Bernstein EF, et al. - In this clinical study, researchers for the first time investigated the safety and efficacy of cryolipolysis for reduction of lateral and central submental fat. As per observations, cryolipolysis for treatment of the entire submental area using overlapping bilateral treatments and a shorter treatment duration was safe and efficacious. Bilateral submental cryolipolysis was well tolerated and produced visible and significant fat layer reduction.

Methods

  • For this study, 14 participants who were treated from January 22 to June 30, 2016, in the lateral and central submental area to reduce unwanted subcutaneous fat were studied.
  • Researchers used a small-volume cup applicator to administer 2 cryolipolysis treatments, delivered in 45-minute treatment cycles in 2 sessions.
  • For the first treatment session, bilateral treatments with approximately 20% overlap of the treatment area were provided to all the participants.
  • The participants were reassessed at the 6-week follow-up visit to examine 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.

Results

  • The adverse effects of the procedure were typically mild among the 14 participants (12 women and 2 men; mean [SD] age, 50.5 [10.4] years); these included numbness and tingling, which resolved without intervention by the final 12-week follow-up visit.
  • In an independent review of digital photographs, findings showed an 81.0% (95% CI, 65.9%-91.4%; P=.02) correct identification rate (34 of 42 images) of the pretreatment and posttreatment images.
  • A mean (SD) fat layer reduction of 2.3 (0.8) mm (range, 0.7-3.5 mm) was evident with Caliper measurements.
  • In this study, three-dimensional imaging demonstrated 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).
  • As per results of participant surveys, 13 participants (93%) were satisfied with the cryolipolysis treatment.

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