CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Collagenase Clostridium Histolyticumdrug
Likely dose
Collagenase Clostridium Histolyticum 0.058 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01613313
NCT01613313Phase 2Completed
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A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma

Zachary Gerut·interventional·Posted Jun 7, 2012·Updated Oct 6, 2016

In Brief

A Phase 2 clinical trial evaluating Collagenase Clostridium Histolyticum for Lipoma. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLipoma
CountriesUnited States
CollaboratorsAdvance Biofactures Corporation

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2012
Enrollment StartMay 1, 2012
Primary CompletionSep 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.1 years ago

Interventions

Collagenase Clostridium Histolyticumdrug

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.