Recruitment

Recruitment Status
Completed
Estimated Enrollment
34

Summary

Conditions
Oral Chronic Graft vs Host Disease
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 12 years and 99 years
Gender
Both males and females

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 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.

Tracking Information

NCT #
NCT01557517
Collaborators
Not Provided
Investigators
Principal Investigator: Steven Z Pavletic, M.D. National Cancer Institute (NCI)