Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-measles Vaccination IDA (Immunothérapie de la Dermatite Atopique)Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effect of anti-measles vaccination on the T cell responses in patients
研究概览
简要总结
Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent, and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a temporary immunosuppression; furthermore, an improvement of AD has been observed during measles infection.
This trial is aimed at demonstrating that measles vaccine is able to create an immunomodulation and to improve AD symptoms.
30 adult patients of both sexes with moderate to severe AD will be randomly assigned to measles vaccine (ROUVAX ®), or placebo (vehicle) and follow-up for 45 days.
The primary outcome is the effect of anti-measles vaccination on the T cell responses in patients; Other outcomes include: clinical evolution of AD, as measured by the SCORAD, the evolution of blood level of measles specific IgE and antibodies; evolution of other biomarkers and phenotypic characteristics of T lymphocytes.
详细描述
Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent, and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a temporary immunosuppression; furthermore, an improvement of AD has been observed during measles infection.
This trial is aimed at demonstrating that measles vaccine is able to create an immunomodulation and to improve AD symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults patients of both sexes, with moderate to severe Atopic Dermatitis (SCORAD (Score for Atopic Dermatitis) ≥ 15).
排除标准
- •hypersensititvity or contra-indication to a Rouvax® component, Tubertest® component, to egg proteins, immunological deficiency, pregnancy, neomycin
- •systemic immnosuppressive treatment in the previous 3 months,
- •topic immunosuppressive treatment during the week preceeding the inclusion (gluco-corticoid, or immunosuppressive agent),
- •fever or acute disease (the inclusion must be postpone in such cases).
研究组 & 干预措施
Placebo
Sub cutaneous injection of vehicle
干预措施: placebo (Biological)
Rouvax
干预措施: ROUVAX (Biological)
结局指标
主要结局
Effect of anti-measles vaccination on the T cell responses in patients
时间窗: 7 / 10 days after vaccine / placebo injection
次要结局
- Clinical evolution of AD, as measured by the SCORAD(3 weeks after injection)
- blood level of measles specific IgE and antibodies(3 weeks after injection)
- Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18(7 days, 14 days, 3 weeks after injection)
- phenotypic characteristics of T lymphocytes(7 days, 14 days, 3 weeks, and 6 weeks after injection)