NCT00673725已完成4 期
A Phase IV,Open Label Study of the Treatment of Children With Moderate to Severe Atopic Dermatitis (AD) Using Locobase® REPAIR as an Adjunctive to Standard Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Change in mEASI from baseline to week 3
研究概览
简要总结
To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has given written informed consent (parents or guardian, child if applicable)
- •Moderate to severe AD
- •Continuous use of topical corticosteroid or topical calcineurin inhibitor (TCI) as active treatment of AD for more than 4 weeks prior to screening (no change in topical corticosteroid or TCI is allowed between screening and day 1)
- •In the opinion of the investigator, subject is unlikely to require a significant change to his/her current treatment regimen during the study period
排除标准
- •Has infected lesions
- •The last assessment of any clinical study within 3 months prior to the expected date of entering into the study
- •Current use of Locobase® REPAIR
- •Known allergy to Locobase® REPAIR or any of its components
- •Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study
研究组 & 干预措施
1
Experimental
干预措施: Locobase® REPAIR (Drug)
结局指标
主要结局
Change in mEASI from baseline to week 3
时间窗: 3 Weeks
次要结局
- Physicians Global Evaluation of Clinical Response(6 Weeks)
研究者
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