Status:
UNKNOWN
Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans
Lead Sponsor:
Federal University of Minas Gerais
Collaborating Sponsors:
Allergan Sales, LLC
Conditions:
Lipid Metabolism Disorders
Metabolic Disease
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The sample will comprise 12 adult women (aged 18 to 40 years) and overweight (BMI\> 24.9 kg / m² and \<30.0 kg / m²). The experimental design will consist of four assessments. In the first assessments...
Detailed Description
This is a longitudinal, non-randomized clinical trial to assess the biology of AT after the use of cryolipolysis. The study will be developed at "Clinica Dra Ligia Colucci" in partnership with the Fed...
Eligibility Criteria
Inclusion
- Subject has clearly visible fat in the flanks and/or abdomen, which in the investigator's opinion, may benefit from the treatment.
- Subject has not had weight change fluctuations exceeding 4.5 kg (or 5% of body weight) in the preceding month.
- Subject has a BMI of 24.9 to 30. A BMI is defined as weight in kilograms divided by height in meters squared (kg/m2).
- Subject agrees to maintain weight (ie, within 5% of body weight) by not making any changes in diet or exercise routine during the course of the study.
- Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
Exclusion
- Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment.
- Subject has had a non-invasive fat reduction and/or body contouring procedure in the area(s) of intended treatment within the past 12 months.
- Subject needs to administer, or has a known history of subcutaneous injections into the area(s) of intended treatment (eg, cortisone, heparin, insulin) within the past 6 months.
- Subject is pregnant or intending to become pregnant. Subject is lactating or has been lactating in the past 6-9 months. Subject is unable or unwilling to comply with study requirements. Subject is currently enrolled in a clinical study of any unapproved investigational device, investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
- Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.
- Subject with known history of cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
- Subject with known sensitivity to cold or has any condition with a known response to cold exposure that limits blood flow to the skin such as cold urticaria or Raynaud's disease, or Chilblains (pernio).
- Subject with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol.
- Subject with impaired peripheral circulation in the area to be treated Subject with neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy.
- Subject with impaired skin sensation. Subject with open or infected wounds. Subject with bleeding disorders, or concomitant use of blood thinners, or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- Subject with recent surgery or scar tissue in the area to be treated. Subject has history of hernia in or adjacent to the treatment area(s) site. Subject with skin conditions such as eczema, dermatitis, or rashes in the area to be treated.
- Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
- Subject is taking or has taken diet pills or supplements within the past 6 months.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
- Subject diagnosed with fibrosis.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04819321
Start Date
April 1 2021
End Date
March 1 2022
Last Update
March 26 2021
Active Locations (1)
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1
Departamento de Nutrição Escola de Enfermagem Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130-100