Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference

Suzanne L Kilmer, Suzanne L Kilmer

Abstract

Background and objectives: Cryolipolysis is a safe, effective non-surgical procedure to reduce fat. For most cryolipolysis treatments, tissue is pulled between parallel cooling plates with a treatment duration of 60 minutes. A novel contoured cup, medium-sized applicator was developed to increase tissue contact with reduced skin tension and reduced treatment time. This prototype contoured cup was investigated with a standard cryolipolysis applicator to evaluate safety, efficacy, and patient preference.

Study design/material and methods: A prototype CoolCup medium-sized vacuum applicator (CoolSculpting System, ZELTIQ Aesthetics) was used to treat n = 19 subjects in the flanks. Randomly assigned, one flank received standard treatment with the CoolCore applicator (-10°C for 60 minutes). The contralateral flank received treatment from the CoolCup (-11°C for 35 minutes). The clinical study primary efficacy endpoint was 70% correct identification of baseline photographs by independent physician review. Incidence of adverse device effects was monitored. Fat layer reduction was measured by ultrasound and subject surveys were administered 12 weeks post-treatment.

Results: Equivalent efficacy was demonstrated between the CoolCore standard treatment and the prototype CoolCup. Independent review from three blinded physicians found 81% correct identification of baseline photographs for the standard treatment and 79% for the CoolCup. Ultrasound measurements indicated mean fat layer reduction of 4.38 mm for the standard treatment and 4.40 mm for the CoolCup; no statistically significant difference was found when comparing treatment efficacy of the two applicators (P = 0.96). Patient questionnaires revealed 85% preferred CoolCup because of shorter treatment duration and greater comfort. Procedural assessments revealed 45% lower pain scores for CoolCup. Immediate post-treatment clinical assessments revealed 82% less bruising. Typical side effects, such as numbness and erythema, were similar. There were no adverse events.

Conclusion: This clinical study of a prototype medium-sized vacuum applicator with a cooled contoured surface indicates that the CoolCup produces equivalent safety and efficacy to the standard CoolCore cryolipolysis applicator. With a 42% reduction in treatment time, the procedure was found to be more comfortable because of lower vacuum skin tension and shorter treatment duration. Lasers Surg. Med. 49:63-68, 2017. © 2016 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Keywords: contoured cooled cup; cryolipolysis; flanks; non-invasive body contouring; non-surgical fat reduction; subcutaneous fat.

© 2016 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Figures

Figure 1
Figure 1
The CoolCup prototype device was created by modifying a commercially‐available CoolCore parallel plate cryolipolysis vacuum applicator (a) with a machined metal insert (b) to provide full cooling surface contact to the sides and top of the tissue drawn into the cooling cup (c).
Figure 2
Figure 2
Comparison of immediate post‐treatment IR thermography images show uniform cooling from the CoolCup (a) and localized cooling around the parallel plates for the CoolCore (b). Subject KIL‐016.
Figure 3
Figure 3
Comparison of immediate post‐treatment photographs showing firm “butter stick” treatment areas from both applicators. No bruising is evident from the CoolCup (a), whereas bruising was observed for the CoolCore (b). Subject KIL‐010.
Figure 4
Figure 4
Baseline (a) and 12 week post‐treatment (b) photos for a 59‐year‐old female. The left flank was treated with the CoolCup for 35 minutes and the right flank was treated with the standard CoolCore for 60 minutes. Weight change −1.6 lbs. (−1.2%) from baseline. Subject KIL‐013.
Figure 5
Figure 5
Baseline (a) and 12 week post‐treatment (b) photos for a 41‐year‐old female. The left flank was treated with the CoolCup for 35 minutes and the right flank was treated with the standard CoolCore for 60 minutes. Weight change −2.8 lbs. (−1.7%) from baseline. Subject KIL‐015.
Figure 6
Figure 6
Baseline (a) and 12 week post‐treatment (b) photos for a 49‐year‐old female. The left flank was treated with the CoolCup for 35 minutes and the right flank was treated with the standard CoolCore for 60 minutes. Weight change −2.6 lbs. (−1.8%) from baseline. Subject KIL‐009.
Figure 7
Figure 7
A commercial version of the prototype cooled cryolipolysis cup applicator will have interchangeable contours for flat and curved treatment sites.

References

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Source: PubMed

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