Prospective Study of Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD) in Stem Cell Transplant Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 40
Healthy Volunteers: f
View:

• Patients with oral chronic graft vs. host disease (cGVHD)

• Stable immune suppression within two weeks of enrollment

• Ages \> 1 year and \< 40 years

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Allison Bartlett, MD
Allison.Bartlett@cchmc.org
(513) 803-0528
Time Frame
Start Date: 2024-09-17
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 13
Treatments
Experimental: Topical Tacrolimus Treatment
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov