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临床试验/NCT04274348
NCT04274348已完成不适用

Role of Staphylococci on Cytokine and T Cell Profiles in the Pathogenesis of Atopic Dermatitis and Eczema Herpeticum

Poitiers University Hospital2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2020年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Quantification of S. aureus colonization level and characterization of bacterial virulence profile in AD lesions.

研究概览

简要总结

Atopic dermatitis (AD) is the most common chronic inflammatory skin disease. Clinical studies have demonstrated a link between staphylococcal skin colonization and the pathogenesis of AD, but the implication of bacterial virulence factors remains largely uncharacterized. Finally, AD is often associated with herpes simplex skin infections. The aim of this project is to investigate the role of staphylococcal toxins in the exacerbation and maintenance of atopic skin inflammation and in the occurrence of infectious complications such as eczema herpeticum.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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 moderate AD (SCORAD between 25 and 50) or severe AD (SCORAD> 50)
  • Skin lesions in the forearms
  • Free subject, without neither guardianship, wardship nor subordination
  • Patient with Social Security
  • Informed and signed consent by the patient after clear and loyal information on the study

排除标准

  • Age < 18 year-old
  • Patients with mild AD (SCORAD < 25)
  • Patients without skin lesions in the forearms
  • Patients treated with dermocorticoid or calcineurin inhibitor for less than two weeks
  • Patients under systemic treatment : Methotrexate, Ciclosporin, Mycophenolate Mofetil, Azathioprine, general corticosteroids for less than 4 weeks
  • Patients under biological treatment : Dupilumab for less than 5 half-lives
  • Patient without Social Security
  • Pregnant and nursing women

结局指标

主要结局

Quantification of S. aureus colonization level and characterization of bacterial virulence profile in AD lesions.

时间窗: 2 hours (with consultation and sample)

Biological data obtained from lesional skin will be compared with those of healthy skin.

次要结局

  • Determination of the inflammatory profile of skin and blood during AD. Definition of the seric cytokine signature characteristic of AD. Characterization of the phenotype and function of the lymphocytic infiltrate T during AD.(2 hours (with consultation and sample))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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