A Randomized Double-Blind Pilot Study of Topical Clobetasol 0.05% Oral Rinse for Oral Chronic Graft-Versus-Host-Disease

Detailed Summary

Background: \- Oral graft-versus-host disease (GVHD) is a possible complication of bone marrow transplants. It is the result of the donor cells trying to attack the recipients body. Symptoms include dry mouth, sensitivity and pain when tasting certain spices and flavors, and painful swallowing. Steroids are a possible effective treatment for GHVD, but they can cause side effects when given as pills or injections. Steroids given in a cream or rinse form, applied directly to the site of the symptoms, can have fewer side effects. However, their effectiveness as a rinse has not been tested in the mouth. Researchers want to see if a steroid called clobetasol can be used as a mouth rinse to treat oral GHVD. Objectives: \- To see if a clobetasol rinse is a safe and effective treatment for oral graft-versus-host disease. Eligibility: \- Individuals at least 12 years of age who have oral GHVD and are not allergic to clobetasol. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will also have an oral exam, a mouth tissue biopsy, and other tests before starting the study drug. * Participants will be separated into two groups. One group will receive clobetasol; the other will have a placebo liquid. * Participants will rinse their mouths with the study liquid three times a day after meals for 2 weeks. * After 2 weeks, participants will have another study visit with blood tests and other exams. * After the study visit, all participants will start to use the clobetasol rinse. Those who originally had clobetasol will use the rinse for another 2 weeks. Those who originally had a placebo will use the rinse for 4 weeks. * Participants will have a follow-up exam after the end of treatment....

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