Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.

Detailed Description
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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.

Official Title
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A Double Blind Study to Evaluate the Safety and Efficacy of Collagenase Clostridium Histolyticum (AA4500) in the Treatment of Lipoma

Conditions
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Lipoma

Intervention / Treatment
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* Drug: AA4500
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years of age, of either sex or any race Clinical history of at least 2 lipomas for at least one year Lipomas diagnosed as benign Two lipomas on distinctly separate parts of the body, or on the torso if 30 cm apart, with easily definable edges Each lipoma is a single mass with easily definable edges Lipomas are 5 to 24 cm squared Women of childbearing potential must use an acceptable method of birth control Exclusion Criteria: Lipomas on the head, neck, hand or foot, or female breast Women who are nursing or pregnant Multi-lobular lipomas Subjects who have received an investigational drug within 30 days before receiving the first dose of study drug in this study Subjects with a known allergy to collagenase or any of the inactive ingredients in XIAFLEX Subjects with uncontrolled diabetes, hypertension, or thyroid disease, or any medical condition that would make the subject unsuitable for enrollment Subjects having prior treatment or trauma of the lipoma that could interfere with study assessments Subjects with a history of connective tissue diseases, rheumatological diseases Subjects taking anticoagulants or planning to receive anticoagulants (except for lo dose aspirin and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days of injection of study drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AA4500<br>single injection of 0.58 mg study drug | Drug: AA4500<br>* Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously<br>* Other names: XIAFLEX, Collagenase Clostridium Histolyticum;|
| Placebo Comparator: Placebo<br>single injection of placebo | Drug: placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 6 months post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Analysis | The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline | 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. | Baseline and 6 months | 
| Subject Satisfaction | Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire | 6 months |