Clobetasol for Oral Graft-Versus-Host Disease
Condition: Oral Chronic Graft vs Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

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....
    

Detailed description: 
      BACKGROUND:

        -  Chronic Graft versus Host Disease (cGVHD) is a major late complication of allogeneic
           hematopoietic stem cell transplantation.

        -  The oral cavity is the second most commonly affected area in cGVHD and is a major cause
           of morbidity.

        -  Clobetasol is a high-potency topical corticosteroid widely used for a variety of
           inflammatory disorders of the skin and oral mucosa.

        -  Treatment of oral cGVHD by topical agents is an attractive strategy to potentially avoid
           adverse effects associated with systemic immunosuppression.

      OBJECTIVES:

      - To investigate efficacy of topical clobetasol 0.05% oral rinse for oral chronic graft
      versus-host disease (cGVHD)

      ELIGIBILITY:

      - Patients age 12-99 years with clinically significant oral cGVHD.

      DESIGN:

        -  This is a randomized, double blind, placebo-controlled, pilot study of clobetasol 0.05%
           topical oral rinse with an open label extension period.

        -  Patients will rinse oral cavity with 10cc of clobetasol 0.05% or placebo oral rinse for
           2 minutes 3 times a day.

        -  Treatment duration will be for 2 weeks in the randomized phase and 2-4 weeks in the open
           label phase.

        -  Up to 40 patients will be enrolled on this pilot trial until 34 evaluable patients are
           assessed.
    

Intervention name(s): Clobetasol Oral Rinse; Placebo oral rinse
Intervention type(s): Drug; Drug
Intervention description(s): Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.; Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.
Intervention MeSH terms: Clobetasol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cGVHD; Oral cGVHD; Topical; Oral Rinse; Clobetasol; Oral Graft-Versus-Host Disease; GVHD