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

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

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.

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