Skip to main content
OpenTrials
Completed

NCT Number: NCT03033004

Cryolipolisis for Abdomen and Flank Fat Reduction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Subcutaneous Fat Disorder

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Estudos e Formação Avançada Ibramed.

Amparo, São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Cryolipolysis

Device

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

Device

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

Device

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 outcomes

  1. Fat layer thickness changes measured by ultrasound

    Time frame: 90 days after randomization

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidade Cidade de Sao Paulo

Other

Collaborators

  • Universidade Federal de Sao Carlos

Registry information

Official study title

Cryolipolisis for Subcutaneous Abodomen and Flank Fat Reduction

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2017
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.