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

6 months post administration study medication

Treatment emergent adverse events were collected after the date of administration of study medication through the last visit at 6 months post administration.