T Central Memory Cells in Early Localized Non-Segmental Vitiligo and the Effect of Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- comparing level of circulating central memory T cells (TCM) in early localized vitiligo cases to healthy controls
研究概览
简要总结
Assessing the level of circulating TCMs (cluster of differentiation (CD) 8+, CD3+,C- chemokine receptor (CCR)7, cluster of differentiation 45 receptor (CD45R) cells) in early localized vitiligo cases prior to treatment and after treatment in comparison to healthy controls. This, in turn, would provide insights regarding the role of TCMs in vitiligo and the role of early treatment in halting disease progression and autoimmune memory formation that accounts for high recurrence rate of vitiligo
详细描述
Assessing the level of circulating TCMs (CD8+ CD3+ CCR7+ CD45RO+ cells) in early localized vitiligo cases where samples will be processed and stained for CD8, CD3, CCR7, . CCR7, CD45R. Multi-parametric flow cytometry will be used to quantify CD3+ve, CD8+ve, CCR7+ve, CD45RO+ve TCM cells percentage, which will be expressed as a percentage from the total lymphocyte gate. This will be done prior to treatment and after treatment and will be compared to healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with vitiligo localized to one anatomical area, of ≤ 6 months' duration
排除标准
- •Patients who received treatment of any type (topical or systemic) within the last 3 months
研究组 & 干预措施
Early localized vitiligo on topical treatment
Cases will only receive topical steroids/ calcineurin inhibitors and targeted phototherapy
干预措施: Topical cream (Drug)
Early localized vitiligo on topical treatment
Cases will only receive topical steroids/ calcineurin inhibitors and targeted phototherapy
干预措施: targeted phototherapy (Device)
Early localized vitiligo on topical and systemic treatment
Cases will receive oral mini-pulse steroids, topical steroids/ calcineurin inhibitors and targeted phototherapy
干预措施: oral mini pulse (Drug)
Early localized vitiligo on topical and systemic treatment
Cases will receive oral mini-pulse steroids, topical steroids/ calcineurin inhibitors and targeted phototherapy
干预措施: Topical cream (Drug)
Early localized vitiligo on topical and systemic treatment
Cases will receive oral mini-pulse steroids, topical steroids/ calcineurin inhibitors and targeted phototherapy
干预措施: targeted phototherapy (Device)
结局指标
主要结局
comparing level of circulating central memory T cells (TCM) in early localized vitiligo cases to healthy controls
时间窗: 6 months
comparing TCM levels in early localized vitiligo cases prior to and after treatment to healthy controls
percent change in the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment
时间窗: 6 months
assessing the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment and calculating percent change in their levels
comparing percent change in the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment in those receiving systemic treatment to those receiving only topical treatment
时间窗: 6 months
assessing the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment and calculating percent change in their levels in those receiving systemic treatment to those receiving only topical treatment
次要结局
未报告次要终点
研究者
Rania Mogawer
principal investigator
Cairo University