NCT01902836已完成2 期
Efficacy of Human Dialyzed Leukocytes Extracts in Paediatrics Patients With Moderate Atopic Dermatitis.
National Polytechnic Institute, Mexico2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Clinical outcome evaluated by SCORAD
研究概览
简要总结
Patients with atopic dermatitis treated with conventional treatment plus Dialyzed Leukocyte Extracts (DLE-oral Transferon) as adjuvant, have better clinical outcome than patients treated only with conventional treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atopic dermatitis diagnosis by Hanifin and Rajka classification
- •Dermatitis severity: Moderate, according with SCORAD index.
- •Patients without treatment of topical steroids or immunosuppressants in the last 3 weeks.
- •Patients with "informed consent form" signed by both parents, or advisor.
- •Patients 7 years old or older whom have signed the assent form
排除标准
- •Patient who were treated with topical, or systemic steroids and/or immunosuppressants and they cannot discontinue their treatment.
- •Patients who lived far from the hospital and they could not go to the visits.
结局指标
主要结局
Clinical outcome evaluated by SCORAD
时间窗: Day 14
To determine clinical outcome by SCORAD.
次要结局
- Immunophenotypical changes induced by adjuvant treatment (DLE) (oral Transferon)(28 days)
研究者
Maria C Jimenez Martinez
PhD
Instituto de Oftalmología Fundación Conde de Valenciana
研究点 (2)
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