Cryolipolisis for Abdomen and Flank Fat Reduction

Subcutaneous Fat Disorder Clinical Trial

Official title:

Cryolipolisis for Subcutaneous Abodomen and Flank Fat Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033004
• Other study ID #: CAAE: 61499416.5.0000.5490
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: April 19, 2018
• Start date: January 2017
• Est. completion date: October 2017

Study information

• Verified date: April 2018
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Lipid Metabolism Disorders
• Subcutaneous Fat Disorder

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Centro de Estudos e Formação Avançada Ibramed.	Amparo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo	Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat layer thickness changes measured by ultrasound		90 days after randomization
Secondary	Fat layer thickness changes measured by ultrasound		30 days after randomization
Secondary	Fat layer thickness changes measured by ultrasound		60 days after randomization
Secondary	Changes in skin viscoelasticity measured by a cutometer		30 days after randomization
Secondary	Changes in skin viscoelasticity measured by a cutometer		60 days after randomization
Secondary	Changes in skin viscoelasticity measured by a cutometer		90 days after randomization
Secondary	Changes in cholesterol levels	Cholesterol levels will be measured in mg/dL	21 days after randomization
Secondary	Changes in triglyceride levels	Triglyceride levels will be measured in mg/dL	21 days after randomization
Secondary	Changes in blood levels of alanine aminotransferase (ALT)		21 days after randomization
Secondary	Changes in blood levels of aspartate transaminase (AST)		21 days after randomization
Secondary	Changes in fasting blood glucose		21 days after randomization
Secondary	Changes in circumference measurements		30 days after randomization
Secondary	Changes in circumference measurements		60 days after randomization
Secondary	Changes in circumference measurements		90 days after randomization
Secondary	Changes in body weight		30 days after randomization
Secondary	Changes in body weight		60 days after randomization
Secondary	Changes in body weight		90 days after randomization
Secondary	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
Secondary	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