Phase 2
N=14
A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma
Lipoma
Bottom Line
View on ClinicalTrials.gov: NCT01613313 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Change in Visible Surface Area of the Lipoma — -31.69; -47.57; -52.42; -66.60 Percent change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Collagenase Clostridium Histolyticum (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zachary Gerut
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visible Surface Area of the Lipoma |
-31.69; -47.57; -52.42; -66.60 | — |
| SECONDARY Relative Change in Volume of the Lipoma |
-54.16; -62.33; -11.35; -34.75 | — |
Summary
The purpose of this research is to evaluate the safest and most effective dose of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors of varying sizes that occur commonly in the adult population). The fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it.
Eligibility Criteria
Inclusion Criteria
- Clinical history lipoma at least one year and no treatment within last 90 days
- Lipoma diagnosed as benign
- Lipoma is a single mass with easily definable edges
- Lipoma has an area of 2.0 to 17 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
- Subjects who have participated in any investigational drug trial within 45 days of enrollment in this study
- Subjects with known allergy to collagenase or any of the inactive ingredients in XIAFLEX
- Subjects with diabetes or any medical condition that would make the subject unsuitable for enrollment.
- Subjects having a history of trauma in the area of the lipoma
- Subjects with a history of connective tissue diseases or rheumatological diseases.
- Subjects with uncontrolled hypertension
- Subjects currently receiving or planning to receive anticoagulant medication except for less than 150 mg aspirin daily and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days before injection of study drug
- Subjects having the following laboratory abnormalities:
- ALT/AST greater than 3 times the upper limit of normal
- Creatinine greater than 2
- Hemoglobin/hematocrit and WBC outside the normal range
Data sourced from ClinicalTrials.gov (NCT01613313). 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.