Chronic Graft Versus Host Disease Oral
Conditions
Brief summary
This study aims to investigate the use of a novel formulation of tacrolimus, as a toothpaste, in a population of patients with oral chronic graft vs. host disease (cGVHD) as an adjunctive therapy in addition to standard-of-care systemic therapy. The investigators plan to summarize our findings to add to the current body of literature regarding managing cGVHD, specifically those with oral involvement. Additionally, establishing effective topical application of tacrolimus in the oral cavity will allow for future prospective studies comparing outcomes for these patients with a more traditional standard of care.
Interventions
DRUGTacrolimus
Participants will receive a tacrolimus treatment via toothpaste application twice daily for three months.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Patients with oral chronic graft vs. host disease (cGVHD) * Stable immune suppression within two weeks of enrollment * Ages \> 1 year and \< 40 years
Exclusion criteria
* Clinically confirmed or suspected herpes simplex virus (HSV) stomatitis * A recent (within 2 weeks of enrollment) escalation in immune suppression or change in systemic immune suppression of ongoing chronic graft vs. host disease (cGVHD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The presence of mucosal ulcerations | Three months | Utilizing the Mucosal Ulceration Index, the patient will be evaluated for the presence of mucosal ulcerations. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAllison Bartlett, MD
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed