NCT00310492已完成3 期
Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study to Demonstrate the Efficacy of a 12-month Subcutaneous Specific Immunotherapy With ALK-depot SQ Milbenmischung in Patients With Atopic Dermatitis and Proven IgE-mediated Sensitization to House Dust Mites
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Changes from baseline in SCORAD and topical medication consumption
研究概览
简要总结
This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment of atopic dermatitis
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive specific IgE to house dust mites
- •Atopic dermatitis according to Hanifin/Rajka
- •Chronic course of Atopic dermatitis
- •SCORAD larger than 25 points
排除标准
- •Erythrodermia
- •Syst.treatment with gcs or immunosuppressive agents in the prev.4 weeks
- •History of specific immunotherapy with mites
- •UV radiation
- •Group 4 topical corticosteroids (European classification)
研究组 & 干预措施
Subcutaneous immunotherapy
Active Comparator
Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U
干预措施: subcutaneous immunotherapy (Biological)
Subcutaneous injections
Placebo Comparator
placebo injections
干预措施: subcutaneous immunotherapy (Biological)
结局指标
主要结局
Changes from baseline in SCORAD and topical medication consumption
时间窗: 1 year
Sccore of atopic dermatitis (SCORAD)
次要结局
- Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption(1 year)
研究者
研究点 (2)
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