The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19
Aesthetic Center
Hewlett, New York, United States
Vanderbilt University
Nashville, Tennessee, United States
Percent Change From Baseline in Surface Area of the Lipoma at Six Months
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.
Time frame: Baseline and 6 months post injection
Responder Analysis
The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline
Time frame: Baseline and 6 months
Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 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.
Time frame: Baseline and 6 months
Subject Satisfaction
Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire
Time frame: 6 months
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