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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-03-31

Brief Summary

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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)

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Detailed Description

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* 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 by mouth rinse four times a day for 5 minutes at a time. After rinsing they will spit out the medication and will not be able to eat or drink for 15 minutes.
* Participants will also take anti-fungal medication (fluconazole) orally once a week.
* After two weeks on study treatment, participants will have a blood drawn to monitor tacrolimus levels.
* After the final treatment (4 weeks), participants will have the following tests and procedures: clinical examination; questionnaire; blood tests; oral culture; optional tissue biopsy.

Conditions

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Oral Chronic Graft-versus-host Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tacrolimus

Tacrolimus Arm Closed to Accrual as of January 2012

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

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

Dexamethasone

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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

Interventions

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Tacrolimus

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

Intervention Type DRUG

Dexamethasone

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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