Clobetasol for Oral Graft-Versus-Host DiseaseLast updated on July 2021
- Recruitment Status
- Estimated Enrollment
- Oral Chronic Graft vs Host Disease
- Phase 2
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment
- Between 12 years and 99 years
- Both males and females
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 u...
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.
- NCT #
- Not Provided
- Principal Investigator: Steven Z Pavletic, M.D. National Cancer Institute (NCI)