A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma
18 Years
75 Years
Both
Lipoma
Trial Information
A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma
Lipomas are common mesenchymal, benign, fatty tumors of varying sizes that occur in the
general adult population. They usually present as painful or annoying lumps that are
palpable and often visible in the subcutaneous tissue. Many subcutaneous lipomas are
asymptomatic and are removed for non-medical reasons. However, they may cause the subject
pain or discomfort or interfere with normal activity.
Spontaneous remission of lipomas has not been reported. A lipoma, once it presents itself,
remains there for the lifetime of a person who carries it and may stay small or become
larger. Alternative treatments of the lipoma are surgery or liposuction. If a large
excision is performed there is the problem of having a very large scar and the accompanying
issues of healing a large scar, or possible formation of a hematoma followed by
consolidation of the hematoma and the remnants of a mass of scar tissue. This is often
painful and more problematic than the original lipoma. liposuction also has the potential
for hematoma formation followed by scar mass residual.
To avoid the complications listed above, a non-invasive method of treatment, such as enzyme
mediated disassociation of adipose tissue, would be desirable. The primary aim of this
study is to perform a step-wise approach in dosing to evaluate the safety and efficacy of
clostridium histolyticum as a non-operative treatment for lipoma.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Reduction in visible surface area of the lipoma
Outcome Description:
The primary efficacy outcome is the visible surface area of the lipoma measured as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be determined by caliper and will be analyzed as the percent change from baseline at the 6-month post injection visit.
Outcome Time Frame:
Six months post injection of study drug
Safety Issue:
No
Principal Investigator
Zachary E Gerut, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gerut, Zachary, M.D.
Authority:
United States: Food and Drug Administration
Study ID:
Lipoma DE/01
NCT ID:
NCT01613313
Start Date:
May 2012
Completion Date:
July 2013
Related Keywords:
- Lipoma
- Lipoma
- Fatty Tumor
- Lipoma
Name | Location |
|---|---|
| Zachary E. Gerut, M.D. | Hewlett, New York 11557 |
