Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD)
NCT ID: NCT06638879
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
13 participants
INTERVENTIONAL
2024-09-17
2026-09-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Topical Tacrolimus Treatment
Tacrolimus
Participants will receive a tacrolimus treatment via toothpaste application twice daily for three months.
Interventions
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Tacrolimus
Participants will receive a tacrolimus treatment via toothpaste application twice daily for three months.
Eligibility Criteria
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Inclusion Criteria
* Stable immune suppression within two weeks of enrollment
* Ages \> 1 year and \< 40 years
Exclusion Criteria
* 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)
1 Year
40 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Allison Bartlett, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Other Identifiers
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2023-0687
Identifier Type: -
Identifier Source: org_study_id
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