Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
NCT00686855 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2014-03-20
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)
Conditions
- Oral Chronic Graft-versus-host Disease
Interventions
- DRUG
-
Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks
- DRUG
-
Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
Sponsors & Collaborators
- collaborator OTHER
- collaborator OTHER
-
Beth Israel Deaconess Medical Center
collaborator OTHER -
Massachusetts General Hospital
collaborator OTHER -
Brigham and Women's Hospital
lead OTHER
Principal Investigators
-
Nathaniel Treister, DMD · Brigham and Women's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 4 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-08-31
- Primary Completion
- 2012-12-31
- Completion
- 2013-03-31
Countries
- United States
Study Locations
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