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 ]

The primary efficacy outcome is lipoma visible surface area defined as the longest dimension ("length") times the longest dimension perpendicular to length ("width"). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit.


Original Primary Outcome: Reduction in Visible Surface Area of the Lipoma [ Time Frame: 6 months post injection ]

The primary efficacy outcome is lipoma visible surface area defined as the longest dimension ("length") times the longest dimension perpendicular to length ("width"). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit.


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