Cryolipolisis for Abdomen and Flank Fat Reduction

Cryolipolisis for Subcutaneous Abodomen and Flank Fat Reduction

Sixty healthy subjects aged between 18 and 50 will be randomly allocated into three treatment groups: Conventional Cryolipolysis, Contrast Cryolipolysis or Recovery Reperfusion Cryolipolysis. The region will be treated according to the individual need, in the region of abdomen and flanks. Assessments of body composition will be performed at baseline and 30, 60 and 90 days after randomization. Blood collections will also be performed at baseline and between 14 and 21 days after randomization for evaluation of lipid profile and liver function.

Study Overview

• Status: Completed
• Conditions: Subcutaneous Fat Disorder
• Intervention / Treatment: Device: Conventional Cryolipolysis; Device: Contrast Cryolipolysis; Device: Reperfusion Cryolipolysis

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Amparo, São Paulo, Brazil
      • Centro de Estudos e Formação Avançada Ibramed.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects
• Body mass index > 29.9 Kg/m2

Exclusion Criteria:

• Pregnancy
• Diabetes
• Cancer
• Vascular diseases
• Heart diseases
• Liposuction or other surgical procedures for body contouring
• Active infection
• Wounds
• Paroxysmal cold hemoglobinuria
• Cold urticaria
• Significant weight changes in the past 3 months or during treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Cryolipolysis; Subjects will receive one treatment session of conventional cryolipolisys. Subcutaneous fat tissue will be cooled with the cryolipolitic device for 60 minutes. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).	Device: Conventional Cryolipolysis; Treatment will be a cold exposure of the subcutaneous fat for 60 minutes using the Polarys device. Polarys is a commercially available cryolipolitic device.
Active Comparator: Contrast Cryolipolysis; Subjects will receive one treatment session of contrast cryolipolisys. Subcutaneous fat tissue will be heated for 10 minutes, cooled for 60 minutes, and heated again for 10 minutes with the cryolipolitic device. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).	Device: Contrast Cryolipolysis; Treatment will consist of a heat exposure of the subcutaneous fat for 10 minutes followed by 60 minutes of cold exposure and 10 minutes of heat exposure again. Cold and heat will be provided by the Polarys device. Polarys is a commercially available cryolipolitic device.
Active Comparator: Reperfusion Cryolipolysis; Subjects will receive one treatment session of Reperfusion Cryolipolysis. Subcutaneous fat tissue will be cooled with the cryolipolitic device for 60 minutes and heated for 10 minutes. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).	Device: Reperfusion Cryolipolysis; Treatment will be a cold exposure of the subcutaneous fat for 60 minutes followed by 10 minutes of heat exposure using the Polarys device. Polarys is a commercially available cryolipolitic device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fat layer thickness changes measured by ultrasound	90 days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat layer thickness changes measured by ultrasound		30 days after randomization
Fat layer thickness changes measured by ultrasound		60 days after randomization
Changes in skin viscoelasticity measured by a cutometer		30 days after randomization
Changes in skin viscoelasticity measured by a cutometer		60 days after randomization
Changes in skin viscoelasticity measured by a cutometer		90 days after randomization
Changes in cholesterol levels	Cholesterol levels will be measured in mg/dL	21 days after randomization
Changes in triglyceride levels	Triglyceride levels will be measured in mg/dL	21 days after randomization
Changes in blood levels of alanine aminotransferase (ALT)		21 days after randomization
Changes in blood levels of aspartate transaminase (AST)		21 days after randomization
Changes in fasting blood glucose		21 days after randomization
Changes in circumference measurements		30 days after randomization
Changes in circumference measurements		60 days after randomization
Changes in circumference measurements		90 days after randomization
Changes in body weight		30 days after randomization
Changes in body weight		60 days after randomization
Changes in body weight		90 days after randomization
Subject's satisfaction with regard to treatment measued by a numeric scale ranging from 1 to 3.	1= unsatisfied; 2= indifferent; 3= satisfied	90 days after randomization
Subject's tolerance with regard to treatment measued by a numeric scale ranging from 1 to 3.	1 = intolerable; 2= tolerable; 3= comfortable	90 days after randomization

Collaborators and Investigators

• Sponsor: Universidade Cidade de Sao Paulo
• Collaborators: Universidade Federal de Sao Carlos

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: CAAE: 61499416.5.0000.5490