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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00757081
First Posted: September 22, 2008
Last Update Posted: February 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
BodyAesthetic Research Center
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolic And Structural Effects Of Phosphatidylcholine And Deoxycholate Injections On Subcutaneous Fat

Resource links provided by NLM:


Further study details as provided by BodyAesthetic Research Center:

Primary Outcome Measures:
  • Subcutaneous fat thickness with calipers and MRI. [ Time Frame: Before and 8 weeks after final treatment ]

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:
  • PPC
  • DC
  • Lipodissolve

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757081


Locations
United States, Missouri
BodyAesthetic Research Center
Creve Coeur, Missouri, United States, 63141
Sponsors and Collaborators
BodyAesthetic Research Center
Investigators
Principal Investigator: V. Leroy Young, M.D. BodyAesthetic Research Center
  More Information

Additional Information:
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
First Submitted: September 19, 2008
First Posted: September 22, 2008
Last Update Posted: February 7, 2013
Last Verified: May 2009

Additional relevant MeSH terms:
Deoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents