An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
- Because no one knows which study option is best, participants will be "randomized" into
one of two study groups: topical dexamethasone or topical tacrolimus.
- Participants will take the medication by mouth rinse four times a day for 5 minutes at
a time. After rinsing they will spit out the medication and will not be able to eat or
drink for 15 minutes.
- Participants will also take anti-fungal medication (fluconazole) orally once a week.
- After two weeks on study treatment, participants will have a blood drawn to monitor
- After the final treatment (4 weeks), participants will have the following tests and
procedures: clinical examination; questionnaire; blood tests; oral culture; optional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate and characterize the clinical efficacy of topical steroid and topical tacrolimus therapies for the treatment of oral cGHVD.
Nathaniel Treister, DMD
Brigham and Women's Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Children's Hospital Boston||Boston, Massachusetts 02115|
|Beth-Israel Deaconess Medical Center||Boston, Massachusetts|