Study to Evaluate the Effect of Injection Lypolysis (Lipodissolve) Treatments to Reduce Body Fat
Metabolic And Structural Effects Of Phosphatidylcholine And Deoxycholate Injections On Subcutaneous Fat
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 19, 2008
CompletedFirst Posted
Study publicly available on registry
September 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFebruary 7, 2013
May 1, 2009
1.5 years
September 19, 2008
February 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Subcutaneous fat thickness with calipers and MRI.
Before and 8 weeks after final treatment
Study Arms (1)
1
EXPERIMENTALInterventions
50 mg phosphatidylcholine, 42 mg deoxycholate subcutaneous injection Every 8 weeks x 2 with additional 2 treatments optional
Eligibility Criteria
You may qualify if:
- Healthy volunteer
- Body Mass Index (BMI) no greater than 30
- Excess fat in the lower abdomen area
You may not qualify if:
- Cigarette smoker
- Diabetes
- Pregnant or breast feeding
- Use anticoagulants (blood thinner), aspirin or other non-steroidal anti-inflammatory drugs that cannot be discontinued
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BodyAesthetic Research Center
Creve Coeur, Missouri, 63141, United States
Related Publications (1)
Reeds DN, Mohammed BS, Klein S, Boswell CB, Young VL. Metabolic and structural effects of phosphatidylcholine and deoxycholate injections on subcutaneous fat: a randomized, controlled trial. Aesthet Surg J. 2013 Mar;33(3):400-8. doi: 10.1177/1090820X13478630. Epub 2013 Feb 25.
PMID: 23439063DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
V. Leroy Young, M.D.
BodyAesthetic Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2008
First Posted
September 22, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
February 7, 2013
Record last verified: 2009-05