drugset
drugset / Trial / NCT01613313

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

NCT01613313 ↗

Phase 2 Completed 14 enrolled Zachary Gerut Advance Biofactures Corporation · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-05
Primary completion
2013-09
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 0.058 mg Other
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 0.15 mg Other
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 0.29 mg Other
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 0.44 mg Other

Indications

lipoma