Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
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.
Age
12–99
Sex
ALL
Healthy volunteers
Not accepted
