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

Lipoma Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lipoma

• NCT number: NCT02249052
• Study type: Interventional
• Source: Gerut, Zachary, M.D.
• Status: Completed
• Phase: Phase 2
• Start date: August 2014
• Completion date: June 2016