Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab
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
- 否
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
研究组 & 干预措施
Conjunctivitis
Patients treated with Dupilumab with conjunctivitis
干预措施: Tears sampling (Other)
Conjunctivitis
Patients treated with Dupilumab with conjunctivitis
干预措施: Lashes sampling (Other)
No conjunctivitis
Patients treated with Dupilumab and showing no signs of ocular involvement
干预措施: Tears sampling (Other)
No conjunctivitis
Patients treated with Dupilumab and showing no signs of ocular involvement
干预措施: Lashes sampling (Other)
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)