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

Phase 1

Recruiting

• Conditions: Chronic Graft Versus Host Disease Oral
• Interventions: Drug: Tacrolimus

• 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.
...

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2024-09-17
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-12
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

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

Read More

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)

Read More

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.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States