NCT00828412已完成4 期
A Randomized, Investigator-Blind, Six-Week, Parallel Group, Multicenter Pilot Study to Compare the Safety and Efficacy of EpiCeram Skin Barrier Emulsion and Desonide Cream 0.05% in the Twice Daily Treatment of Pediatric Subjects With Moderate Atopic Dermatitis
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
- 100
- 试验地点
- 5
- 主要终点
- Change From Baseline in Three Item Severity Score
研究概览
简要总结
This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.
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
- Single (Investigator)
入排标准
- 年龄范围
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 3 months of age and less than 13 years of age
- •atopic dermatitis of moderate severity
排除标准
- •pregnant or lactating
- •treatment of atopic dermatitis with topical product in the 14 days prior to Baseline
- •treatment of atopic dermatitis with systemic product in the 30 days prior to Baseline
- •serious or uncontrolled medical condition
- •active infection
- •significant use of inhaled, intranasal, or intraocular corticosteroid
研究组 & 干预措施
1
Active Comparator
EpiCeram Skin Barrier Emulsion
干预措施: EpiCeram Skin Barrier Emulsion (Device)
2
Active Comparator
Desonide Cream 0.05%
干预措施: Desonide Cream 0.05% (Drug)
结局指标
主要结局
Change From Baseline in Three Item Severity Score
时间窗: Baseline to 6 weeks
The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9.
次要结局
未报告次要终点
研究者
研究点 (5)
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