NCT06638879

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

Prospective Study of Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD) in Stem Cell Transplant Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 1 Year – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Graft Versus Host Disease Oral

Interventions

Type	Name	Description
DRUG	Tacrolimus	Participants will receive a tacrolimus treatment via toothpaste application twice daily for three months.

Timeline

• Start date: 2024-09-17
• Primary completion: 2025-09-16
• Completion: 2026-02-18
• First posted: 2024-10-15
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study