NCT03160976

Cryolipolysis on Localized Adiposity

Effects of Cryolipolysis on Localized Adiposity: Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Federal University of Health Science of Porto Alegre · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to analyze the effects of a single session of cryolipolysis on localized adiposity on women's abdomen. This is a randomized controlled clinical trial that will include 28 women who will be randomly allocated into two groups: Control Group or Intervention Group. The following assessments will be performed in both groups: ultrasonography and body composition at baseline and 30, 60 and 90 days after randomization and blood analysis at baseline and 15 and 30 days after randomization. The expected main result at the end of this study is the reduction of the local subcutaneous fat tissue.

Detailed description

Cryolipolysis is a non - invasive method for localized fat reduction wich uses low temperatures to induce an apoptotic and inflammatory response and consequent adipocyte death in the treated area. Although the practice of this technique has been increasing, there are some gaps in the literature about the exact mechanism of action and only a few randomized clinical trials that proves its effectiveness and safety. Then, the aim of this study is to analyse the effects of cryolipolysis on localized fat on women's abdomen. This is a randomized controlled clinical trial that will include 28 women who will be randomized to Control Group (CG) or Intervention Group (IG). The CG will perform the Evaluation Protocol with the following assessments: ultrasonography, thermographic analysis, blood analysis, bioimpedance and measurement of skinfold and abdominal circumference. The IG will receive a single cryolipolysis's session on lower abdomen and the Evaluation Protocol. The follow up for both groups is 90 days. Expected main result at the end of the study is the reduction of the local subcutaneous fat tissue.

Conditions

• Subcutaneous Fat

Interventions

Type	Name	Description
OTHER	Cryolipolysis	First, the demarcation of the lower abdomen area at the same landmarks of the ultrasonography will be done. Secondly, the patient will be positioned on the stretcher in the supine position with a 45 ° elevation of the trunk. In this position, to protect the region to be treated, a glycerine antifreeze membrane will be placed. The treatment parameters will be: temperature of -10 ° C, treatment time of 50 minutes (first 3 minutes of heating at 42°C) and moderate vacuum pressure (60 - 40 Kpas). The applicator will be chosen according to the size of the area of each subject and positioned in the target region. At the end the skinfold will be released automatically, the antifreeze membrane removed and a manual massage will be carried out for five minutes to stimulate local blood reperfusion.

Timeline

• Start date: 2017-05-25
• Primary completion: 2017-08-25
• Completion: 2017-10-25
• First posted: 2017-05-19
• Last updated: 2017-05-24

Locations

1 site across 1 country: Brazil