NCT02176551撤回3 期
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Product 0405 To A Vehicle Control In The Treatment Of Mild To Moderate Atopic Dermatitis In Pediatric Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Statistically significant superiority of the test Product 0405 to the vehicle
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.
详细描述
Treatment medication will be administered topically twice daily for 28 days
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of Atopic Dermatitis
- •Good health with the exception of Atopic Dermatitis
- •Percent body surface area minimum requirements
排除标准
- •Subjects who are pregnant, nursing or planning a pregnancy
研究组 & 干预措施
Product 0405
Experimental
Topical active investigational Product 0405
干预措施: Product 0405 (Drug)
Placebo for Product 0405
Placebo Comparator
Topical Placebo for Product 0405
干预措施: Placebo for Product 0405 (Drug)
结局指标
主要结局
Statistically significant superiority of the test Product 0405 to the vehicle
时间窗: 28 days
Statistically significant superiority of the test Product 0405 to the vehicle
次要结局
- Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.(28 days)
研究者
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