Clinical trial · Interventional
Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
A Double Blind Study to Evaluate the Safety and Efficacy of Collagenase Clostridium Histolyticum (AA4500) in the Treatment of Lipoma
NCT02249052CI-TRIAL-00026072completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lipoma | Lipoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AA4500 | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- AA4500
- description
- single injection of 0.58 mg study drug
- interventionNames
- Drug: AA4500
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- single injection of placebo
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- Percent Change From Baseline in Surface Area of the Lipoma at Six Months
- timeFrame
- Baseline and 6 months post injection
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.