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

NCT06638879 | Completed Phase 1 FDA Drug

• 1 other identifier: 2023-0687
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Graft Versus Host Disease Oral

Outcome Measures

Primary Outcomes (1)

• The presence of mucosal ulcerations

  Utilizing the Mucosal Ulceration Index, the patient will be evaluated for the presence of mucosal ulcerations.

  Three months

Study Arms (1)

Topical Tacrolimus Treatment

EXPERIMENTAL

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

Participants will receive a tacrolimus treatment via toothpaste application twice daily for three months.

Topical Tacrolimus Treatment

Eligibility Criteria

• Age: 1 Year - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Allison Bartlett, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: September 17, 2024
• Primary Completion: September 16, 2025
• Study Completion: February 18, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (1)