Cryolipolisis for Abdomen and Flank Fat Reduction

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Cryolipolisis for Subcutaneous Abodomen and Flank Fat Reduction

Conditions
-----------------
Subcutaneous Fat Disorder

Intervention / Treatment
-----------------
* Device: Conventional Cryolipolysis
* Device: Contrast Cryolipolysis
* Device: Reperfusion Cryolipolysis


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Cryolipolysis<br>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<br>* Treatment will be a cold exposure of the subcutaneous fat for 60 minutes using the Polarys device. Polarys is a commercially available cryolipolitic device.<br>|
| Active Comparator: Contrast Cryolipolysis<br>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<br>* 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.<br>|
| Active Comparator: Reperfusion Cryolipolysis<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |