Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD)

Completed · Phase 1

Conditions studied: Chronic Graft Versus Host Disease Oral

In brief

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.

Key facts

Study ID

NCT06638879

Run by

Children's Hospital Medical Center, Cincinnati

People needed

7

Starts

2024-09-17

Expected to finish

2026-02-18

Last updated by the study team

2026-03-06

Who can join

Age: 1 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with oral chronic graft vs. host disease (cGVHD)
• Stable immune suppression within two weeks of enrollment
• Ages > 1 year and < 40 years

You may not qualify if…

• 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)

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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