Cryolipolisis for Abdomen and Flank Fat Reduction

Sponsor

Universidade Cidade de Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT03033004

Collaborator

Universidade Federal de Sao Carlos (Other)

Enrollment

Location

Arms

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subcutaneous Fat Disorder	Device: Conventional Cryolipolysis Device: Contrast Cryolipolysis Device: Reperfusion Cryolipolysis	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Cryolipolisis for Subcutaneous Abodomen and Flank Fat Reduction

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Fat layer thickness changes measured by ultrasound [90 days after randomization]

Secondary Outcome Measures

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 [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]
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. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro de Estudos e Formação Avançada Ibramed.	Amparo	São Paulo	Brazil

Sponsors and Collaborators

Universidade Cidade de Sao Paulo
Universidade Federal de Sao Carlos

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Richard Eloin Liebano, PT, PhD, Universidade Cidade de Sao Paulo

ClinicalTrials.gov Identifier:

NCT03033004

Other Study ID Numbers:

CAAE: 61499416.5.0000.5490

First Posted:

Jan 26, 2017

Last Update Posted:

Apr 20, 2018

Last Verified:

Apr 1, 2018

Additional relevant MeSH terms:

Lipid Metabolism Disorders

Study Results

No Results Posted as of Apr 20, 2018