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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BodyAesthetic Research Center
ClinicalTrials.gov Identifier:
NCT00757081
First received: September 19, 2008
Last updated: February 6, 2013
Last verified: May 2009

September 19, 2008
February 6, 2013
June 2008
December 2009   (final data collection date for primary outcome measure)
Subcutaneous fat thickness with calipers and MRI. [ Time Frame: Before and 8 weeks after final treatment ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00757081 on ClinicalTrials.gov Archive Site
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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

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.

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Interventional
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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Abdominal Subcutaneous Fat
Drug: phosphatidylcholine and deoxycholate
50 mg phosphatidylcholine, 42 mg deoxycholate subcutaneous injection Every 8 weeks x 2 with additional 2 treatments optional
Other Names:
  • PPC
  • DC
  • Lipodissolve
Experimental: 1
Intervention: Drug: phosphatidylcholine and deoxycholate
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00757081
LD-001
No
BodyAesthetic Research Center
BodyAesthetic Research Center
Not Provided
Principal Investigator: V. Leroy Young, M.D. BodyAesthetic Research Center
BodyAesthetic Research Center
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP