Completed

NCT Number: NCT00686855

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

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)

Completed

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Key information

Conditions

Oral Chronic Graft-versus-host Disease

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth-Israel Deaconess Medical Center, Boston, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

Patients already on topical steroid or tacrolimus therapies

Treatment and study plan

Tacrolimus

Drug

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

Dexamethasone

Drug

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

Primary outcomes

The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.

Time frame: Participants were assessed at Baseline and 4 weeks after start of therapy

Participants were given a survey at the time of screening and 4 weeks after start of therapy. The participants self-reported three symptoms of oral cGVHD: oral sensitivity, mouth pain, and mouth dryness. Each symptom was given a score ranging from 0-10, with 0 as none and 10 as the worst. Improvement in subjective scores was defined as 3 points or further reduction from pre-treatment to post-treatment assessment.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

Beth Israel Deaconess Medical Center
Boston Children's Hospital
Dana-Farber Cancer Institute
Massachusetts General Hospital

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2013
First posted: May 30, 2008
Registry last updated: Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.