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Cryolipolisis for Abdomen and Flank Fat Reduction

Primary Purpose

Subcutaneous Fat Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Conventional Cryolipolysis
Contrast Cryolipolysis
Reperfusion Cryolipolysis
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subcutaneous Fat Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centro de Estudos e Formação Avançada Ibramed.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Conventional Cryolipolysis

Contrast Cryolipolysis

Reperfusion Cryolipolysis

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

Fat layer thickness changes measured by ultrasound

Secondary Outcome Measures

Fat layer thickness changes measured by ultrasound
Fat layer thickness changes measured by ultrasound
Changes in skin viscoelasticity measured by a cutometer
Changes in skin viscoelasticity measured by a cutometer
Changes in skin viscoelasticity measured by a cutometer
Changes in cholesterol levels
Cholesterol levels will be measured in mg/dL
Changes in triglyceride levels
Triglyceride levels will be measured in mg/dL
Changes in blood levels of alanine aminotransferase (ALT)
Changes in blood levels of aspartate transaminase (AST)
Changes in fasting blood glucose
Changes in circumference measurements
Changes in circumference measurements
Changes in circumference measurements
Changes in body weight
Changes in body weight
Changes in body weight
Subject's satisfaction with regard to treatment measued by a numeric scale ranging from 1 to 3.
1= unsatisfied; 2= indifferent; 3= satisfied
Subject's tolerance with regard to treatment measued by a numeric scale ranging from 1 to 3.
1 = intolerable; 2= tolerable; 3= comfortable

Full Information

First Posted
January 10, 2017
Last Updated
April 19, 2018
Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Universidade Federal de Sao Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT03033004
Brief Title
Cryolipolisis for Abdomen and Flank Fat Reduction
Official Title
Cryolipolisis for Subcutaneous Abodomen and Flank Fat Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Universidade Federal de Sao Carlos

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subcutaneous Fat Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Cryolipolysis
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Contrast Cryolipolysis
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Reperfusion Cryolipolysis
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Conventional Cryolipolysis
Intervention Description
Treatment will be a cold exposure of the subcutaneous fat for 60 minutes using the Polarys device. Polarys is a commercially available cryolipolitic device.
Intervention Type
Device
Intervention Name(s)
Contrast Cryolipolysis
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Reperfusion Cryolipolysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fat layer thickness changes measured by ultrasound
Time Frame
90 days after randomization
Secondary Outcome Measure Information:
Title
Fat layer thickness changes measured by ultrasound
Time Frame
30 days after randomization
Title
Fat layer thickness changes measured by ultrasound
Time Frame
60 days after randomization
Title
Changes in skin viscoelasticity measured by a cutometer
Time Frame
30 days after randomization
Title
Changes in skin viscoelasticity measured by a cutometer
Time Frame
60 days after randomization
Title
Changes in skin viscoelasticity measured by a cutometer
Time Frame
90 days after randomization
Title
Changes in cholesterol levels
Description
Cholesterol levels will be measured in mg/dL
Time Frame
21 days after randomization
Title
Changes in triglyceride levels
Description
Triglyceride levels will be measured in mg/dL
Time Frame
21 days after randomization
Title
Changes in blood levels of alanine aminotransferase (ALT)
Time Frame
21 days after randomization
Title
Changes in blood levels of aspartate transaminase (AST)
Time Frame
21 days after randomization
Title
Changes in fasting blood glucose
Time Frame
21 days after randomization
Title
Changes in circumference measurements
Time Frame
30 days after randomization
Title
Changes in circumference measurements
Time Frame
60 days after randomization
Title
Changes in circumference measurements
Time Frame
90 days after randomization
Title
Changes in body weight
Time Frame
30 days after randomization
Title
Changes in body weight
Time Frame
60 days after randomization
Title
Changes in body weight
Time Frame
90 days after randomization
Title
Subject's satisfaction with regard to treatment measued by a numeric scale ranging from 1 to 3.
Description
1= unsatisfied; 2= indifferent; 3= satisfied
Time Frame
90 days after randomization
Title
Subject's tolerance with regard to treatment measued by a numeric scale ranging from 1 to 3.
Description
1 = intolerable; 2= tolerable; 3= comfortable
Time Frame
90 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Centro de Estudos e Formação Avançada Ibramed.
City
Amparo
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

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