A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma

Phase 2

Completed

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Dose #1	Collagenase Clostridium Histolyticum	single injection 0.058 mg Collagenase Clostridium Histolyticum
Dose #2	Collagenase Clostridium Histolyticum	single injection 0.15 mg Collagenase Clostridium Histolyticum
Dose #3	Collagenase Clostridium Histolyticum	single injection 0.29 mg Collagenase Clostridium Histolyticum
Dose #4	Collagenase Clostridium Histolyticum	single injection 0.44 mg Collagenase Clostridium Histolyticum

Primary Outcome Measures

Name	Time	Method
Change in Visible Surface Area of the Lipoma	Baseline and Six months post injection of study drug	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.

Secondary Outcome Measures

Name	Time	Method
Relative Change in Volume of the Lipoma	Baseline and 6 months post injection of study drug	A secondary outcome is the relative change in volume of the lipoma as determined by MRI. This outcome will be analyzed as the change from baseline to 6 months post injection.