Clinical Trial: Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double Blind Study to Evaluate the Safety and Efficacy of Collagenase Clostridium Histolyticum (AA4500) in the Treatment of Lipoma
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 Summary: 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.
Sponsor: Gerut, Zachary, M.D.
Current Primary Outcome: Percent Change From Baseline in Surface Area of the Lipoma at Six Months [ Time Frame: Baseline and 6 months post injection ]
Original Primary Outcome: Reduction in Visible Surface Area of the Lipoma [ Time Frame: 6 months post injection ]
Current Secondary Outcome:
- Responder Analysis [ Time Frame: Baseline and 6 months ]The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline
- Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months [ Time Frame: Baseline and 6 months ]Change from baseline in lipoma length Calculated as the percent change from baseline for length of the lipoma treated with AA4500 and the lipoma treated with placebo.
- Subject Satisfaction [ Time Frame: 6 months ]Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire
Original Secondary Outcome:
- Number participants with 50% or greater reduction in lipoma surface area relative to baseline [ Time Frame: 6 months ]The percent of subjects with at least 50% reduction in visible lipoma surface area will be compared for drug treated and placebo treated lipomas
- Superiority of study drug over placebo [ Time Frame: 6 months ]Assessment of reduction in lipoma surface area of drug versus placebo
Information By: Gerut, Zachary, M.D.
Dates:
Date Received: August 18, 2014
Date Started: August 2014
Date Completion:
Last Updated: January 6, 2017
Last Verified: August 2016