Neoplasms

All Conditions

Lipoma

Neoplasms, Adipose Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

single injection 0.058 mg Collagenase Clostridium Histolyticum

single injection 0.15 mg Collagenase Clostridium Histolyticum

single injection 0.29 mg Collagenase Clostridium Histolyticum

single injection 0.44 mg Collagenase Clostridium Histolyticum

This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Collagenase Clostridium Histolyticum

Zachary E Gerut, M.D.

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.

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.

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

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.

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.

Advance Biofactures Corporation

Zachary Gerut

Sponsor-Investigator

single injection 0.058 mg Collagenase Clostridium Histolyticum

Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Dose #1

single injection 0.15 mg Collagenase Clostridium Histolyticum

Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Dose #2

single injection 0.29 mg Collagenase Clostridium Histolyticum

Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Dose #3

single injection 0.44 mg Collagenase Clostridium Histolyticum

Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Dose #4

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Zachary E.Gerut

This is a proof of concept dose escalation study. No power justification has been implemented. Descriptive data provided for each arm.

Analysis population consists of all subjects who were enrolled and received the administration of study drug.

Change in Visible Surface Area of the Lipoma

This is a proof of concept dose escalation study. No power of justification was implemented. Descriptive statistics was provided for each arm only.

Analysis is based on the population that consists of all subjects who are enrolled and received administration of study drug

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma	NCT01613313	Lipoma	Collagenase Clo...	18 Years - 75 Years	Gerut, Zachary, M.D.
A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma	NCT01613313	Lipoma	Collagenase Clo...	18 Years - 75 Years	Gerut, Zachary, M.D.

Spots Global Cancer Trial Database for fatty tumor

Every month we try and update this database with for fatty tumor cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fatty tumor

Every month we try and update this database with for fatty tumor cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fatty tumor cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.