A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research is to evaluate the safest and most effective dose of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors of varying sizes that occur commonly in the adult population). 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zachary Gerut
• Collaborator: Advance Biofactures Corporation

Criteria

Inclusion Criteria:

• Clinical history lipoma at least one year and no treatment within last 90 days

• Lipoma diagnosed as benign

• Lipoma is a single mass with easily definable edges

• Lipoma has an area of 2.0 to 17 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

• Subjects who have participated in any investigational drug trial within 45 days of enrollment in this study

• Subjects with known allergy to collagenase or any of the inactive ingredients in XIAFLEX

• Subjects with diabetes or any medical condition that would make the subject unsuitable for enrollment.

• Subjects having a history of trauma in the area of the lipoma

• Subjects with a history of connective tissue diseases or rheumatological diseases.

• Subjects with uncontrolled hypertension

• Subjects currently receiving or planning to receive anticoagulant medication except for less than 150 mg aspirin daily and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days before injection of study drug

• Subjects having the following laboratory abnormalities:

• ALT/AST greater than 3 times the upper limit of normal

• Creatinine greater than 2

• Hemoglobin/hematocrit and WBC outside the normal range