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Subcutaneous Fat DisorderNCT03033004

Cryolipolisis for Abdomen and Flank Fat Reduction

A study testing Conventional Cryolipolysis, Contrast Cryolipolysis and Reperfusion Cryolipolysis in people with Subcutaneous Fat Disorder, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Subcutaneous Fat Disorder
What is being tested?
Conventional Cryolipolysis, Contrast Cryolipolysis and Reperfusion Cryolipolysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
Jan 2017to Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subjects
  • Body mass index > 29.9 Kg/m2

Who cannot join

  • Pregnancy
  • Diabetes
  • Cancer
  • Vascular diseases
  • Heart diseases
  • Liposuction or other surgical procedures for body contouring
Show all 11Show fewer
  • Active infection
  • Wounds
  • Paroxysmal cold hemoglobinuria
  • Cold urticaria
  • Significant weight changes in the past 3 months or during treatment

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Centro de Estudos e Formação Avançada Ibramed.

    Amparo, São Paulo

Other trials in Brazil

About this study

Official title: Cryolipolisis for Subcutaneous Abodomen 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.

Being tested
Conventional Cryolipolysis, Contrast Cryolipolysis, Reperfusion Cryolipolysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional CryolipolysisDevice

    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 CryolipolysisDevice

    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 CryolipolysisDevice

    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.

Study groups in NCT03033004
Study groupRoleWhat they receive
Conventional CryolipolysisActive comparatorSubjects 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).
Receives: Device: Conventional Cryolipolysis
Contrast CryolipolysisActive comparatorSubjects 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).
Receives: Device: Contrast Cryolipolysis
Reperfusion CryolipolysisActive comparatorSubjects 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).
Receives: Device: Reperfusion Cryolipolysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fat layer thickness changes measured by ultrasound

    Measured: 90 days after randomization

Secondary outcomes (18)

  1. Fat layer thickness changes measured by ultrasound

    Measured: 30 days after randomization

  2. Fat layer thickness changes measured by ultrasound

    Measured: 60 days after randomization

  3. Changes in skin viscoelasticity measured by a cutometer

    Measured: 30 days after randomization

  4. Changes in skin viscoelasticity measured by a cutometer

    Measured: 60 days after randomization

  5. Changes in skin viscoelasticity measured by a cutometer

    Measured: 90 days after randomization

  6. Changes in cholesterol levels

    Cholesterol levels will be measured in mg/dL

    Measured: 21 days after randomization

  7. Changes in triglyceride levels

    Triglyceride levels will be measured in mg/dL

    Measured: 21 days after randomization

  8. Changes in blood levels of alanine aminotransferase (ALT)

    Measured: 21 days after randomization

  9. Changes in blood levels of aspartate transaminase (AST)

    Measured: 21 days after randomization

  10. Changes in fasting blood glucose

    Measured: 21 days after randomization

  11. Changes in circumference measurements

    Measured: 30 days after randomization

  12. Changes in circumference measurements

    Measured: 60 days after randomization

  13. Changes in circumference measurements

    Measured: 90 days after randomization

  14. Changes in body weight

    Measured: 30 days after randomization

  15. Changes in body weight

    Measured: 60 days after randomization

  16. Changes in body weight

    Measured: 90 days after randomization

  17. Subject's satisfaction with regard to treatment measued by a numeric scale ranging from 1 to 3.

    1= unsatisfied; 2= indifferent; 3= satisfied

    Measured: 90 days after randomization

  18. Subject's tolerance with regard to treatment measued by a numeric scale ranging from 1 to 3.

    1 = intolerable; 2= tolerable; 3= comfortable

    Measured: 90 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completionAug 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03033004
Sponsor's protocol ID
CAAE: 61499416.5.0000.5490
Status last verified
Apr 2018
First submitted
10 Jan 2017
Last updated
20 Apr 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Cryolipolysis, Contrast Cryolipolysis and Reperfusion Cryolipolysis in people with Subcutaneous Fat Disorder, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fat layer thickness changes measured by ultrasound (time frame: 90 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03033004.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.

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