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Toothpaste aimed at treating chronic mouth sores in transplant patients shows early promise

NCT ID NCT06638879

Disease control Sponsor: Children's Hospital Medical Center, Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 1 study tested a special toothpaste containing tacrolimus in 7 patients with oral chronic graft vs. host disease (cGVHD) after a stem cell transplant. Participants used the toothpaste twice daily for three months alongside their usual medications. The goal was to see if it could help manage painful mouth ulcers and gather information for future larger studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tacrolimus toothpaste
What this could lead to
If this works, it could offer a new topical option to manage painful mouth sores from chronic graft vs. host disease after a stem cell transplant.
What could go wrong
This is a very early Phase 1 study with only 7 participants, so results may not apply to everyone. It is not a cure and is meant only as an add-on to standard therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

7 people

The number who actually took part.

Started

Sep 2024

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

chronic graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic graft versus host disease oral

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States