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

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
AA4500	AA4500	single injection of 0.58 mg study drug
Placebo	placebo	single injection of placebo

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Surface Area of the Lipoma at Six Months	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.

Secondary Outcome Measures

Name	Time	Method
Responder Analysis	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	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	6 months	Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire