A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma|
- Reduction in visible surface area of the lipoma [ Time Frame: Six months post injection of study drug ] [ Designated as safety issue: No ]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.
- Relative change in volume of the lipoma [ Time Frame: 6 months post injection of study drug ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2012|
|Study Completion Date:||October 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Drug: Collagenase Clostridium Histolyticum
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.
|United States, New York|
|Zachary E. Gerut, M.D.|
|Hewlett, New York, United States, 11557|
|Principal Investigator:||Zachary E Gerut, M.D.||Gerut, Zachary, M.D.|