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Tacrolimus Toothpaste for Graft-versus-Host Disease

Phase 1
Recruiting
Led By Allison Bartlett, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with oral chronic graft vs. host disease (cGVHD)
Ages > 1 year and < 40 years
Must not have
Clinically confirmed or suspected herpes simplex virus (HSV) stomatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new toothpaste containing tacrolimus in patients with oral chronic graft vs. host disease (cGVHD) alongside their usual treatment. The goal is to see if using

Who is the study for?
This trial is for patients with oral chronic graft vs. host disease (cGVHD), specifically those who have complications like Bronchiolitis Obliterans Syndrome, Graft-versus-Host Disease, or Oral mucositis. Participants should be currently receiving standard systemic therapy for cGVHD.
What is being tested?
The study is testing tacrolimus toothpaste as an additional treatment for oral cGVHD. The goal is to see if applying tacrolimus directly in the mouth helps manage symptoms better than the usual care alone.
What are the potential side effects?
Tacrolimus may cause side effects such as burning or irritation in the mouth where it's applied, increased risk of infections due to immune system suppression, and potentially other local or systemic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have chronic graft-versus-host disease affecting my mouth.
Select...
I am between 1 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have or might have a cold sore outbreak in my mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three months
This trial's timeline: 3 weeks for screening, Varies for treatment, and three months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The presence of mucosal ulcerations

Side effects data

From 2022 Phase 4 trial • 97 Patients • NCT03020589
98%
Anemia
83%
Hypomagnesemia
75%
Leukopenia
70%
Hyperkalemia
57%
Abnormal renal function
50%
Hypophosphatemia
50%
Increase creatinine
45%
Hyperglycemia
33%
Delayed Graft Function Requiring Dialysis
30%
Diarrhea
30%
Nausea
28%
Headache
28%
Hypertension
25%
Tremor
25%
Infection
23%
Constipation
23%
Edema
20%
Vomiting
18%
Hyperlipidemia
18%
Hypokalemia
10%
Biopsy Proven Acute Rejection
8%
Neurotoxicity
3%
Graft loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
CYP3A5 Based Tacrolimus Dosing
Control

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Topical Tacrolimus TreatmentExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
2019
Completed Phase 4
~5510

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
837 Previous Clinical Trials
6,565,324 Total Patients Enrolled
Allison Bartlett, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
2 Previous Clinical Trials
64 Total Patients Enrolled
~9 spots leftby Sep 2026
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