Tacrolimus toothpaste for treating oral chronic graft vs. host disease
Prospective Study of Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD) in Stem Cell Transplant Patients
This study is testing a new tacrolimus toothpaste to see if it can help people with oral chronic graft vs. host disease feel better alongside their usual treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 1 Year to 40 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06638879 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel formulation of tacrolimus delivered as a toothpaste for patients suffering from oral chronic graft vs. host disease (cGVHD). It aims to evaluate the effectiveness of this topical treatment as an adjunct to standard systemic therapies. The findings will contribute to the existing literature on managing cGVHD, particularly in patients with oral manifestations. The study will also lay the groundwork for future research comparing this approach to traditional treatments.
Who should consider this trial
Good fit: Ideal candidates are patients aged 1 to 40 years with stable oral chronic graft vs. host disease.
Not a fit: Patients with clinically confirmed or suspected herpes simplex virus stomatitis or recent changes in their immune suppression regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and localized therapy for patients with oral cGVHD, improving their quality of life.
How similar studies have performed: While this approach is novel, similar studies exploring topical treatments for cGVHD have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Allison Bartlett, MD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Allison Bartlett, MD
- Email: Allison.Bartlett@cchmc.org
- Phone: (513) 803-0528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.