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NCT06638879 · ClinicalTrials.gov registry record · Phase 1
Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD)
A Phase 1 study of Chronic Graft Versus Host Disease Oral, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT06638879: Completed Phase 1 study of Chronic Graft Versus Host Disease Oral, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT06638879 is a Phase 1 study of Chronic Graft Versus Host Disease Oral that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06638879, a Phase 1 study of Chronic Graft Versus Host Disease Oral, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Utilizing the Mucosal Ulceration Index, the patient will be evaluated for the presence of mucosal ulcerations.
Conditions Studied
Interventions
- DRUG Tacrolimus
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2024-09-17 |
| Est. Completion | 2026-02-18 |
| Phase | Phase 1 |
What the finished NCT06638879 record still lists
NCT06638879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Chronic Graft Versus Host Disease Oral appearing as the primary indexed condition, and to 1 intervention - of which Tacrolimus is the first listed.
NCT06638879 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06638879 about?
NCT06638879 is a clinical study titled "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 a...
What is the current status of trial NCT06638879?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2024-09-17. Estimated completion is 2026-02-18.
What conditions does trial NCT06638879 study?
This clinical trial studies the following conditions: Chronic Graft Versus Host Disease Oral.
What interventions are being tested in trial NCT06638879?
The interventions under investigation include: Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT06638879?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06638879 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06638879's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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