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Cryolipolisis for Abdomen and Flank Fat Reduction

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ClinicalTrials.gov Identifier: NCT03033004
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Universidade Federal de Sao Carlos
Information provided by (Responsible Party):
Richard Eloin Liebano, Universidade Cidade de Sao Paulo

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 2017
Actual Primary Completion Date : August 2017
Actual Study Completion Date : October 2017

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.




Primary Outcome Measures :
  1. Fat layer thickness changes measured by ultrasound [ Time Frame: 90 days after randomization ]

Secondary Outcome Measures :
  1. Fat layer thickness changes measured by ultrasound [ Time Frame: 30 days after randomization ]
  2. Fat layer thickness changes measured by ultrasound [ Time Frame: 60 days after randomization ]
  3. Changes in skin viscoelasticity measured by a cutometer [ Time Frame: 30 days after randomization ]
  4. Changes in skin viscoelasticity measured by a cutometer [ Time Frame: 60 days after randomization ]
  5. Changes in skin viscoelasticity measured by a cutometer [ Time Frame: 90 days after randomization ]
  6. Changes in cholesterol levels [ Time Frame: 21 days after randomization ]
    Cholesterol levels will be measured in mg/dL

  7. Changes in triglyceride levels [ Time Frame: 21 days after randomization ]
    Triglyceride levels will be measured in mg/dL

  8. Changes in blood levels of alanine aminotransferase (ALT) [ Time Frame: 21 days after randomization ]
  9. Changes in blood levels of aspartate transaminase (AST) [ Time Frame: 21 days after randomization ]
  10. Changes in fasting blood glucose [ Time Frame: 21 days after randomization ]
  11. Changes in circumference measurements [ Time Frame: 30 days after randomization ]
  12. Changes in circumference measurements [ Time Frame: 60 days after randomization ]
  13. Changes in circumference measurements [ Time Frame: 90 days after randomization ]
  14. Changes in body weight [ Time Frame: 30 days after randomization ]
  15. Changes in body weight [ Time Frame: 60 days after randomization ]
  16. Changes in body weight [ Time Frame: 90 days after randomization ]
  17. Subject's satisfaction with regard to treatment measued by a numeric scale ranging from 1 to 3. [ Time Frame: 90 days after randomization ]
    1= unsatisfied; 2= indifferent; 3= satisfied

  18. Subject's tolerance with regard to treatment measued by a numeric scale ranging from 1 to 3. [ Time Frame: 90 days after randomization ]
    1 = intolerable; 2= tolerable; 3= comfortable



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033004


Locations
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Brazil
Centro de Estudos e Formação Avançada Ibramed.
Amparo, São Paulo, Brazil
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Universidade Federal de Sao Carlos
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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: January 26, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases