Cryolipolisis for Abdomen and Flank Fat Reduction

Universidade Cidade de Sao Paulo60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Subcutaneous Fat Disorder

Interventions

Conventional CryolipolysisDEVICE

Treatment will be a cold exposure of the subcutaneous fat for 60 minutes using the Polarys device. Polarys is a commercially available cryolipolitic device.

Contrast CryolipolysisDEVICE

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.

Reperfusion CryolipolysisDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Centro de Estudos e Formação Avançada Ibramed.

Amparo, São Paulo, Brazil

Outcomes

Primary Outcomes

Fat layer thickness changes measured by ultrasound

Time frame: 90 days after randomization

Secondary Outcomes

Fat layer thickness changes measured by ultrasound

Time frame: 30 days after randomization

Fat layer thickness changes measured by ultrasound

Time frame: 60 days after randomization

Changes in skin viscoelasticity measured by a cutometer

Time frame: 30 days after randomization

Changes in skin viscoelasticity measured by a cutometer

Time frame: 60 days after randomization

Changes in skin viscoelasticity measured by a cutometer

Time frame: 90 days after randomization

Changes in cholesterol levels

Cholesterol levels will be measured in mg/dL

Time frame: 21 days after randomization

Changes in triglyceride levels

Triglyceride levels will be measured in mg/dL

Time frame: 21 days after randomization

Changes in blood levels of alanine aminotransferase (ALT)

Time frame: 21 days after randomization

Changes in blood levels of aspartate transaminase (AST)

Time frame: 21 days after randomization

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.