Status:
COMPLETED
Deoxycholic Acid Injection for the Treatment of Superficial Lipomas
Lead Sponsor:
Kythera Biopharmaceuticals
Conditions:
Lipoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas.
Detailed Description
A lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wris...
Eligibility Criteria
Inclusion
- One or more lipomas, based on clinical 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 by greatest perpendicular width between 1 and 16 square centimeters, inclusive
- Discrete, oval to rounded in shape, not hard or attached to underlying tissue
- Located on the trunk, arms, legs, or neck
- Stable body weight with a body mass index of less than 30 kg/m²
- Signed informed consent
Exclusion
- Absence of significant medical conditions that could affect safety
- History of surgical treatment for lipomas
- Treatment with an investigational agent within 30 days before ATX-101 treatment
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00422188
Start Date
January 1 2007
End Date
November 1 2007
Last Update
December 10 2015
Active Locations (1)
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1
Therapeutics Clinical Research
San Diego, California, United States, 92123