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Study to Evaluate the Effect of Injection Lypolysis (Lipodissolve) Treatments to Reduce Body Fat

Not Applicable
Completed
Conditions
Abdominal Subcutaneous Fat
Interventions
Registration Number
NCT00757081
Lead Sponsor
BodyAesthetic Research Center
Brief Summary

The combination of phosphatidylcholine (PPC) and deoxycholate (DC) injected into subcutaneous fat is often popularly referred to as "Lipodissolve" therapy. Despite its attractiveness as an easy and noninvasive cosmetic treatment, the safety, effectiveness, and how the injections might work remain unclear. This study will investigate the hypothesis that injections of PPC/DC will reduce the amount body fat in the treated area. If so, the mechanisms responsible for the fat loss will be explored to find out whether fat cells die from toxic effects or are broken apart by the PPC/DC. Patients will receive at least 2 (no more than 4) treatments with PPC/DC injections every 2 months. Several methods of measuring fat loss will be used in the study, including photography and measurement of patients, tissue biopsy, blood tests, and MRI. The study will also record side effects of the treatments as well as patient satisfaction.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Healthy volunteer
  • Body Mass Index (BMI) no greater than 30
  • Excess fat in the lower abdomen area
Exclusion Criteria
  • Cigarette smoker
  • Diabetes
  • Pregnant or breast feeding
  • Use anticoagulants (blood thinner), aspirin or other non-steroidal anti-inflammatory drugs that cannot be discontinued

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1phosphatidylcholine and deoxycholate-
Primary Outcome Measures
NameTimeMethod
Subcutaneous fat thickness with calipers and MRI.Before and 8 weeks after final treatment
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

BodyAesthetic Research Center

🇺🇸

Creve Coeur, Missouri, United States

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