Active rewarming after cryolipolysis on the lower Abdomen- a randomized prospective blinded comparison of fat layer reduction in active rewarmed and not active rewarmed tissue
- Conditions
- E65Localized adiposity
- Registration Number
- DRKS00013777
- Lead Sponsor
- KlinikumStadtSoest
- Brief Summary
The side effects - edema, erythema and hypesthesia - faded almost completely with heating, whereas they remained on the non-heated site. However, the mean sonographic reduction of local adipose tissue after 12 weeks was significantly lower on the heated than on the control sites (9.6% vs. 14.1%; p=0.0003). The overall satisfaction was high (9.2 out of 10 points), even though only 44% of participants had a subjective recognition of fat loss without difference between the sites.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 25
healthy subjects of full age, capacity of consent
underage, pregnancy, dermal illness of the Abdomen, cryoglobulinemia, severe medical conditions, active Cancer, coagulation disorder, anticoagulants intake, fatty tissue disorder, Pacemaker, cold agglutinins
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fat layer thickness in the lower Abdomen 12 weeks after Treatment, <br>Measurement via Caliper, Abdominal girth (1/2 circumference on each side) and ultrasound
- Secondary Outcome Measures
Name Time Method satisfaction and complaints up to 12 weeks after Treatment determinded on the Basis of a questionnaire and pain diary