Cryolipolysis for safe and effective inner thigh fat reduction

Brian D Zelickson, A Jay Burns, Suzanne L Kilmer, Brian D Zelickson, A Jay Burns, Suzanne L Kilmer

Abstract

Background and objectives: While cryolipolysis initially received FDA clearance for fat reduction in the abdomen and flanks, there was significant interest in non-surgical fat reduction for other sites, such as the inner and outer thighs. This article reports the results of an inner thigh study which contributed to FDA clearance of cryolipolysis for treatment of thighs.

Study design/material and methods: A flat cup vacuum applicator (CoolFit applicator, CoolSculpting System) was used to treat 45 subjects bilaterally in the inner thighs. Single cycle treatments were delivered at Cooling Intensity Factor (CIF) 41.6 for 60 minutes followed by 2 minutes of manual massage. Follow-up visits were conducted at 8 and 16 weeks. Efficacy was assessed by ultrasound imaging, circumference measurements, and photographs. Safety was assessed by monitoring adverse events. Patient satisfaction was evaluated by questionnaire.

Results: Data is presented for n = 42 patients that completed the 16 week study follow-up and maintained their weight within 5 lbs. of baseline. Independent photo review from three blinded physicians found 91% correct identification of baseline clinical photographs. Ultrasound data indicate fat layer reduction of 2.8 mm. Circumferential measurements indicate mean reduction of 0.9 cm. Patient questionnaires reveal 93% were satisfied with the CoolSculpting procedure; 84% noticed visible fat reduction; 89% would recommend to a friend; and 91% were likely to have a second treatment. There were no device- or procedure-related serious adverse events.

Conclusion: The CoolFit flat cup vacuum applicator was found to deliver safe and effective cryolipolysis treatment to reduce inner thigh fat. Completed 16-week data from 42 subjects show 2.8 mm reduction in fat thickness and 0.9 cm reduction in circumference. Assessment of clinical photographs found 91% correct identification of baseline images. The results of this prospective, multi-center, interventional clinical study contributed to FDA clearance of cryolipolysis for treatment of thighs in April 2014.

Keywords: cryolipolysis; inner thighs; non-invasive body contouring; non-surgical fat reduction; subcutaneous fat.

© 2015 Wiley Periodicals, Inc.

Figures

Figure 1
Figure 1
Comparison of the A) flat cup CoolFit and B) contoured cup CoolCore vacuum applicators.
Figure 2
Figure 2
Cryolipolysis treatment steps for the inner thigh. A) The protective gelpad was placed over the inner thigh. B) The flat cup vacuum applicator was placed over the treatment area and vacuum suction was initiated. C) The patient was seated with the legs slightly bent during treatment. D) Manual massage was administered following device removal.
Figure 3
Figure 3
Baseline (A, B) and 16 week (C, D) post‐treatment photos for subject ZEL‐011. Weight change −1.0 lbs. from baseline. Procedure by Dr. Brian Zelickson.
Figure 4
Figure 4
Baseline (A, B) and 16 week (C, D) post‐treatment photos for subject BUR‐011. Weight change −1.2 lbs. from baseline. Procedure by Dr. Jay Burns.
Figure 5
Figure 5
Baseline (A, B) and 16 week (C, D) post‐treatment photos for subject KIL‐003. No weight change from baseline. Procedure by Dr. Suzanne Kilmer.
Figure 6
Figure 6
Baseline (A, B) and 16 week (C, D) post‐treatment photos for subject ZEL‐008. Weight change −1.0 lbs. from baseline. Procedure by Dr. Brian Zelickson.
Figure 7
Figure 7
Baseline (A) and 16 week (B) post‐treatment ultrasound images for subject ZEL‐008. The same anatomical feature is indicated in the baseline and post‐treatment images to demonstrate fat reduction.
Figure 8
Figure 8
Baseline (A) and 16 week (B) post‐treatment ultrasound images for subject BUR‐011. The same anatomical feature is indicated in the baseline and post‐treatment images to demonstrate fat reduction.

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Source: PubMed

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