Expired Study
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Nashville, Tennessee 37215


Purpose:

The purpose of this research is to compare the safety and effectiveness of three different concentrations (amount of study drug in a liquid preparation) of an investigational drug (sodium deoxycholate for injection) solution against a placebo (a solution that looks similar but does not have any active drug in it) in the treatment of superficial lipomas.


Study summary:

The purpose of this research is to compare the safety and effectiveness of three different concentrations (amount of study drug in a liquid preparation) of an investigational drug (sodium deoxycholate for injection) solution against a placebo (a solution that looks similar but does not have any active drug in it) in the treatment of superficial lipomas. Sodium deoxycholate for injection is a chemical similar to the one produced by the body. A lipoma is a fatty lump typically located on the trunk, shoulder, arms and legs. For the purposes of this study, only lipomas on the trunk, arms, legs or neck will be treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles or feet will not be treated.)


Criteria:

Inclusion Criteria: - One or more lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least two perpendicular diameters, and have the following characteristics: - History of slow growth followed by dormancy, and stable for at least six months. - Greatest length by greatest perpendicular width between 1 and 16 square centimeters - Discrete, oval tor rounded in shape, not hard or attached to underlying tissue. - Located on the trunk, arms, legs, or neck. - Signed informed consent. Exclusion Criteria: - Absence of significant medical conditions that could affect safety. - History of treatment for lipomas. - Treatment with an investigational agent within 30 days before ATX-101 treatment.


NCT ID:

NCT00608842


Primary Contact:

Study Director
Patricia S. Walker, M.D., Ph.D.
Kythera Biopharmaceuticals, Inc.


Backup Contact:

N/A


Location Contact:

Nashville, Tennessee 37215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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