Phase 2
N=19
Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
Lipoma
Bottom Line
View on ClinicalTrials.gov: NCT02249052 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Percent Change From Baseline in Surface Area of the Lipoma at Six Months — -81.277; 2.053 percentage change from baseline — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AA4500 (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gerut, Zachary, M.D.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Surface Area of the Lipoma at Six Months |
-81.277; 2.053 | <0.0001 sig |
| SECONDARY Responder Analysis |
17; 0 | <.0001 sig |
| SECONDARY Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months |
-64.1818; 0.156 | — |
| SECONDARY Subject Satisfaction |
18; 7 | — |
Summary
The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02249052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.