Abdominal Subcutaneous Fat
Conditions
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.
Interventions
DRUGphosphatidylcholine and deoxycholate
50 mg phosphatidylcholine, 42 mg deoxycholate subcutaneous injection Every 8 weeks x 2 with additional 2 treatments optional
Sponsors
BodyAesthetic Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subcutaneous fat thickness with calipers and MRI. | Before and 8 weeks after final treatment |
Countries
United States
Outcome results
None listed