Cryolipolysis on Localized Adiposity

Federal University of Health Science of Porto Alegre

Status: Unknown

Conditions: Subcutaneous Fat

Treatments: Other: Cryolipolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03160976

ECLA2017

Details and patient eligibility

About

The aim of this study is to analyze the effects of a single session of cryolipolysis on localized adiposity on women's abdomen. This is a randomized controlled clinical trial that will include 28 women who will be randomly allocated into two groups: Control Group or Intervention Group. The following assessments will be performed in both groups: ultrasonography and body composition at baseline and 30, 60 and 90 days after randomization and blood analysis at baseline and 15 and 30 days after randomization. The expected main result at the end of this study is the reduction of the local subcutaneous fat tissue.

Full description

Cryolipolysis is a non - invasive method for localized fat reduction wich uses low temperatures to induce an apoptotic and inflammatory response and consequent adipocyte death in the treated area. Although the practice of this technique has been increasing, there are some gaps in the literature about the exact mechanism of action and only a few randomized clinical trials that proves its effectiveness and safety. Then, the aim of this study is to analyse the effects of cryolipolysis on localized fat on women's abdomen. This is a randomized controlled clinical trial that will include 28 women who will be randomized to Control Group (CG) or Intervention Group (IG). The CG will perform the Evaluation Protocol with the following assessments: ultrasonography, thermographic analysis, blood analysis, bioimpedance and measurement of skinfold and abdominal circumference. The IG will receive a single cryolipolysis's session on lower abdomen and the Evaluation Protocol. The follow up for both groups is 90 days. Expected main result at the end of the study is the reduction of the local subcutaneous fat tissue.

Enrollment: 28 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• Age 18 to 45 or not being on menopause
• Sedentary according to International Physical Activity Questionnaire
• Body Mass Index lower than 27 Kg/m²
• Skinfold: more than 3 centimeters at the lower abdomen

Exclusion criteria

• Cryoglobulinemia
• Cold urticaria
• Paroxysmal cold hemoglobinuria
• Raynaud disease
• Pregnancy and Breastfeeding
• Cancer
• Vascular diseases
• Heart diseases
• Epidermal lesions at the site of application
• Autoimmune diseases
• Osteoporosis
• Metallic implants and pacemaker
• Alterations of sensibility
• Inflammatory process and active infection
• Abdominal hernia
• Abdominal muscle diastasis
• Diabetes
• Anemia
• Previous plastic surgery on the area
• Liver and kidney diseases
• Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Control Group

No Intervention group

Description:

Subjects will only receive the Evaluation Protocol and will be followed for 90 days.

Intervention Group

Active Comparator group

Description:

A single 50 minutes session of cold exposure with a cryolipolysis device. The parameters will be: temperature -10°C and vacuum between 60 Kpas (at beginning) and 40 Kpas (until the end).

Treatment:

Other: Cryolipolysis