Subcutaneous Fat Disorder
Conditions
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.
Interventions
DEVICEConventional 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.
DEVICEContrast 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.
DEVICEReperfusion 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.
Sponsors
Universidade Cidade de Sao Paulo
Universidade Federal de Sao Carlos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fat layer thickness changes measured by ultrasound | 90 days after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in skin viscoelasticity measured by a cutometer | 30 days after randomization | — |
| Changes in cholesterol levels | 21 days after randomization | Cholesterol levels will be measured in mg/dL |
| Changes in triglyceride levels | 21 days after randomization | Triglyceride levels will be measured in mg/dL |
| Changes in blood levels of alanine aminotransferase (ALT) | 21 days after randomization | — |
| Changes in blood levels of aspartate transaminase (AST) | 21 days after randomization | — |
| Fat layer thickness changes measured by ultrasound | 30 days after randomization | — |
| Changes in circumference measurements | 30 days after randomization | — |
| Changes in body weight | 30 days after randomization | — |
| Subject's satisfaction with regard to treatment measued by a numeric scale ranging from 1 to 3. | 90 days after randomization | 1= unsatisfied; 2= indifferent; 3= satisfied |
| Subject's tolerance with regard to treatment measued by a numeric scale ranging from 1 to 3. | 90 days after randomization | 1 = intolerable; 2= tolerable; 3= comfortable |
| Changes in fasting blood glucose | 21 days after randomization | — |
Countries
Brazil
Outcome results
None listed