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OpenTrials
Completed

NCT Number: NCT06638879

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

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.

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Key information

Conditions

Chronic Graft Versus Host Disease Oral

Age range

1 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tacrolimus

Drug

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

Primary outcomes

  1. The presence of mucosal ulcerations

    Time frame: Three months

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.