CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Tacrolimus +1 moredrug
Likely dose
Not stated in 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/NCT00686855
NCT00686855Phase 2Completed
CompareCT.gov

An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease

Brigham and Women's Hospital·interventional·Posted May 30, 2008·Updated Mar 20, 2014

In Brief

A Phase 2 clinical trial evaluating Tacrolimus and Dexamethasone for Oral Chronic Graft-versus-host Disease. Completed, enrolled 46 participants across 5 sites.

Detailed Summary

The purpose of this research study is to determine the effectiveness of topical steroid therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment of oral chronic Graft-Versus-Host Disease (cGVHD)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Chronic Graft-versus-host Disease
CountriesUnited States
CollaboratorsDana-Farber Cancer Institute, Boston Children's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 30, 2008
Enrollment StartAug 1, 2008
Primary CompletionDec 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.1 years ago

Interventions

Tacrolimusdrug

Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks

Dexamethasonedrug

Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks