Status:

COMPLETED

Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease

Lead Sponsor:

Brigham and Women's Hospital

Collaborating Sponsors:

Dana-Farber Cancer Institute

Boston Children's Hospital

Conditions:

Oral Chronic Graft-versus-host Disease

Eligibility:

All Genders

4+ years

Phase:

PHASE2

Brief 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 Graf...

Detailed Description

* Because no one knows which study option is best, participants will be "randomized" into one of two study groups: topical dexamethasone or topical tacrolimus. * Participants will take the medication ...

Eligibility Criteria

Inclusion

  • Patients with oral chronic graft-versus-host disease
  • Patients 4 years of age or older
  • Stable cGVHD medication regimen for the four weeks prior to study enrollment

Exclusion

  • Patients already on topical steroid or tacrolimus therapies

Key Trial Info

Start Date :

August 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2013

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT00686855

Start Date

August 1 2008

End Date

March 1 2013

Last Update

March 20 2014

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

2

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

3

Children's Hospital Boston

Boston, Massachusetts, United States, 02115

4

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02115