Status:
COMPLETED
Phase 2 Study for the Treatment of Superficial Lipomas
Lead Sponsor:
Kythera Biopharmaceuticals
Conditions:
Lipoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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.
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, wri...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00608842
Start Date
November 1 2007
End Date
January 1 2010
Last Update
January 14 2016
Active Locations (7)
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1
Gary D. Monheit, M.D.
Birmingham, Alabama, United States, 35205
2
Stacy R. Smith
San Diego, California, United States, 92123
3
Steven Grekin, D.O.
Warren, Michigan, United States, 48088
4
Joel Schlessinger, M.D.
Omaha, Nebraska, United States, 68144