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

Cincinnati Children's Hospital Medical Center

Status and phase: Enrolling; Phase 1

Conditions: Chronic Graft Versus Host Disease Oral

Treatments: Drug: Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT06638879

2023-0687

Details and patient eligibility

About

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.

Enrollment: 13 estimated patients

Sex: All

Ages: 1 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

13 participants in 1 patient group

Topical Tacrolimus Treatment

Experimental group

Treatment:

Drug: Tacrolimus