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Brief Title: Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
Official Title: A Double Blind Study to Evaluate the Safety and Efficacy of Collagenase Clostridium Histolyticum (AA4500) in the Treatment of Lipoma
Study ID: NCT02249052
Brief Summary: The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.
Detailed Description: This study will evaluate the safety and efficacy of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors). The fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it. Each subject must have two lipomas; one lipoma to be treated with placebo and one lipoma to be treated with study drug, both to be observed similarly throughout the trial.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Aesthetic Center, Hewlett, New York, United States
Vanderbilt University, Nashville, Tennessee, United States
Name: Zachary E Gerut, MD
Affiliation: Private Practice
Role: PRINCIPAL_INVESTIGATOR