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
  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

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 ] [ 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:
  • PPC
  • DC
  • Lipodissolve

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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 October 19, 2014