Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD)
- Registration Number
- NCT06638879
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 13
- Patients with oral chronic graft vs. host disease (cGVHD)
- Stable immune suppression within two weeks of enrollment
- Ages > 1 year and < 40 years
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Topical Tacrolimus Treatment Tacrolimus -
- Primary Outcome Measures
Name Time Method The presence of mucosal ulcerations Three months Utilizing the Mucosal Ulceration Index, the patient will be evaluated for the presence of mucosal ulcerations.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States