Prospective Study of Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD) in Stem Cell Transplant Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- The presence of mucosal ulcerations
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with oral chronic graft vs. host disease (cGVHD)
- •Stable immune suppression within two weeks of enrollment
- •Ages > 1 year and < 40 years
排除标准
- •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)
研究组 & 干预措施
Topical Tacrolimus Treatment
干预措施: Tacrolimus (Drug)
结局指标
主要结局
The presence of mucosal ulcerations
时间窗: Three months
Utilizing the Mucosal Ulceration Index, the patient will be evaluated for the presence of mucosal ulcerations.
次要结局
未报告次要终点