Status:
COMPLETED
Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
Lead Sponsor:
Gerut, Zachary, M.D.
Collaborating Sponsors:
Advance Biofactures Corporation
Conditions:
Lipoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 exc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02249052
Start Date
August 1 2014
End Date
June 1 2016
Last Update
February 23 2017
Active Locations (2)
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1
Aesthetic Center
Hewlett, New York, United States, 11557
2
Vanderbilt University
Nashville, Tennessee, United States, 37232