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

Abdominal Subcutaneous Fat Clinical Trial

Official title:

Metabolic And Structural Effects Of Phosphatidylcholine And Deoxycholate Injections On Subcutaneous Fat

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757081
• Other study ID #: LD-001
• Status: Completed
• Phase: N/A
• First received: September 19, 2008
• Last updated: February 6, 2013
• Start date: June 2008
• Est. completion date: December 2009

Study information

• Verified date: May 2009
• Source: BodyAesthetic Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Subcutaneous Fat

Intervention

Drug:
• phosphatidylcholine and deoxycholate
50 mg phosphatidylcholine, 42 mg deoxycholate subcutaneous injection Every 8 weeks x 2 with additional 2 treatments optional

Locations

Country	Name	City	State
United States	BodyAesthetic Research Center	Creve Coeur	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
BodyAesthetic Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subcutaneous fat thickness with calipers and MRI.		Before and 8 weeks after final treatment	No

External Links

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