跳至主要内容
临床试验/NCT04066998
NCT04066998Unknown不适用

Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab

Centre Hospitalier Universitaire de Besancon0 个研究点目标入组 15 人开始时间: 2019年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
主要终点
Increase of lacrimal inflammatory cytokines

研究概览

简要总结

This study aims to assess the cytokine profile of tears in patients suffering from conjunctivitis versus patients without ocular involvement, when treated with Dupilumab

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with severe atopic dermatitis resistant to main immunosuppressive drugs
  • treated with Dupilumab
  • with or without conjunctivitis
  • postmenopausal women (since minimum 24 months), surgically sterilized women or women on contraception

排除标准

  • pregnant or breastfeeding women

结局指标

主要结局

Increase of lacrimal inflammatory cytokines

时间窗: Month 8

Change in inflammatory cytokines in tears collected by capillary before and after treatment with Dupilumab. Analysis will be performed by flow cytometry. Concentrations of the following cytokines wil be measured: interleukin-1 β, interleukin-3, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-13, interleukin-17, interferon α, Tumor Necrosis Factor α.

次要结局

  • Comparison of the increase of lacrimal inflammatory cytokines between the 2 groups(Month 8)
  • Absence/Presence of demodex(Day 0)
  • Increase of lacrimal eosinophiles(Month 8)
  • Improvement of quality of life(Month 8)

研究者

申办方类型
Other
责任方
Sponsor

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