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OpenTrials
Completed

NCT Number: NCT00757081

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

Conditions

Abdominal Subcutaneous Fat

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BodyAesthetic Research Center

Creve Coeur, Missouri, 63141, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phosphatidylcholine and deoxycholate

Drug

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

Other names: PPC, DC, Lipodissolve

Primary outcomes

  1. Subcutaneous fat thickness with calipers and MRI.

    Time frame: Before and 8 weeks after final treatment

Sponsors and collaborators

Lead sponsor

BodyAesthetic Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2008
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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