Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma (NCT02249052) | Clinical Trial Compass
CompletedPhase 2
Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
United States19 participantsStarted 2014-08
Plain-language summary
The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Percent Change From Baseline in Surface Area of the Lipoma at Six Months