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

Tracking Information
First Submitted Date ICMJE	September 19, 2008
First Posted Date ICMJE	September 22, 2008
Last Update Posted Date	February 7, 2013
Study Start Date ICMJE	June 2008
Actual Primary Completion Date	December 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 22, 2009)	Subcutaneous fat thickness with calipers and MRI. [ Time Frame: Before and 8 weeks after final treatment ]
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00757081 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study to Evaluate the Effect of Injection Lypolysis (Lipodissolve) Treatments to Reduce Body Fat
Official Title ICMJE	Metabolic And Structural Effects Of Phosphatidylcholine And Deoxycholate Injections On Subcutaneous Fat
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 Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Abdominal Subcutaneous Fat
Intervention ICMJE	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
Study Arms	Experimental: 1; Intervention: Drug: phosphatidylcholine and deoxycholate
Publications *	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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 19, 2008)	20
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2009
Actual Primary Completion Date	December 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years to 65 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00757081
Other Study ID Numbers ICMJE	LD-001
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	BodyAesthetic Research Center
Study Sponsor ICMJE	BodyAesthetic Research Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: V. Leroy Young, M.D. BodyAesthetic Research Center
PRS Account	BodyAesthetic Research Center
Verification Date	May 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP