Phase 2 Study for the Treatment of Superficial Lipomas
Completed · Phase 2 · Has a placebo group
Conditions studied: Lipoma
In brief
The purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for injection against a placebo in the treatment of superficial lipomas.
Key facts
- Study ID
- NCT00608842
- Run by
- Kythera Biopharmaceuticals
- People needed
- 62
- Starts
- 2007-11-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2016-01-14
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- One or more lipomas, based on clinical and histological diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:
- History of slow growth followed by dormancy, and stable for at least 6 months
- Greatest length multiplied by greatest perpendicular width between 1 and 16 cm², inclusive
- Discrete, oval to rounded in shape, not hard or attached to underlying tissue
- Without changes in overlying skin (ie, inflammation, pain or tenderness, hyperpigmentation)
- Located on the trunk, arms, legs, or neck
- Signed informed consent.
You may not qualify if…
- Absence of significant medical conditions that could affect safety
- History of surgical or deoxycholate treatment for lipomas
- Treatment with an investigational agent within 30 days before ATX-101 treatment
Where it is running
- Gary D. Monheit, M.D. — Birmingham, Alabama, United States
- Stacy R. Smith — San Diego, California, United States
- Steven Grekin, D.O. — Warren, Michigan, United States
- Joel Schlessinger, M.D. — Omaha, Nebraska, United States
- David J. Goldberg, M.D. — Westwood, New Jersey, United States
- Neil S. Sadick, M.D. — New York, New York, United States
- Michael H. Gold, M.D. — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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