Study to Evaluate the Effect of Injection Lypolysis (Lipodissolve) Treatments to Reduce Body Fat
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Abdominal Subcutaneous Fat |
Drug: phosphatidylcholine and deoxycholate |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Metabolic And Structural Effects Of Phosphatidylcholine And Deoxycholate Injections On Subcutaneous Fat |
- Subcutaneous fat thickness with calipers and MRI. [ Time Frame: Before and 8 weeks after final treatment ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: phosphatidylcholine and deoxycholate
50 mg phosphatidylcholine, 42 mg deoxycholate subcutaneous injection Every 8 weeks x 2 with additional 2 treatments optional
Other Names:
|
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, Missouri | |
| BodyAesthetic Research Center | |
| Creve Coeur, Missouri, United States, 63141 | |
| Principal Investigator: | V. Leroy Young, M.D. | BodyAesthetic Research Center |
More Information
Additional Information:
No publications provided by BodyAesthetic Research Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | BodyAesthetic Research Center |
| ClinicalTrials.gov Identifier: | NCT00757081 History of Changes |
| Other Study ID Numbers: | LD-001 |
| Study First Received: | September 19, 2008 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Deoxycholic Acid Cholagogues and Choleretics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013