Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
Completed · Phase 2 · Has a placebo group
Conditions studied: Lipoma
In brief
The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.
Key facts
- Study ID
- NCT02249052
- Run by
- Gerut, Zachary, M.D.
- People needed
- 19
- Starts
- 2014-08-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2017-02-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Aesthetic Center — Hewlett, New York, United States
- Vanderbilt University — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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