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

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gerut, Zachary, M.D.
• Collaborator: Advance Biofactures Corporation

Criteria

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