NCT02249052

Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma

A Double Blind Study to Evaluate the Safety and Efficacy of Collagenase Clostridium Histolyticum (AA4500) in the Treatment of Lipoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Gerut, Zachary, M.D. · Individual
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.

Detailed description

This study will evaluate the safety and efficacy of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors). 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. Each subject must have two lipomas; one lipoma to be treated with placebo and one lipoma to be treated with study drug, both to be observed similarly throughout the trial.

Conditions

• Lipoma

Interventions

Type	Name	Description
DRUG	AA4500	Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously
DRUG	placebo	Placebo

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-04-01
• Completion: 2016-06-01
• First posted: 2014-09-25
• Last updated: 2017-02-23
• Results posted: 2016-12-13

Locations

2 sites across 1 country: United States