A Double-Blind, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of an Over-the-Counter Cream in the Management of Mild to Moderate Atopic Dermatitis in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Eczema Area and Severity Index (EASI)
研究概览
简要总结
This three week study will be conducted to determine the safety and efficacy of an over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.
详细描述
The objective of this trial is to evaluate the efficacy and safety of an OTC colloidal oatmeal skin protectant cream in children with mild to moderate AD in comparison to that of EpiCeram®
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 6 mo- 18 years
- •Any ethnicity
- •Diagnosed with atopic dermatitis (AD) per Hanifin-Rajka criteria
- •Mild to moderate atopic dermatitis per Rajka-Langeland severity index
- •Willing to use only provided cream and body wash for duration of study
排除标准
- •Known sensitivity to investigational products
- •Pregnant or breastfeeding
- •Severe AD per Rajka-Langeland severity index
- •AD requiring class I (super potent) or class II or III (potent) topical steroids
- •Requires greater than 2.0 g inhaled or intranasal corticosteroids
- •Other skin conditions which may interfere with the scoring of AD
研究组 & 干预措施
19306-127
Experimental Topical cream applied twice daily (or as needed)
干预措施: Colloidal Oatmeal (Drug)
19306-137
Marketed Topical cream applied twice daily (or as needed)
干预措施: Topical Cream (Device)
结局指标
主要结局
Eczema Area and Severity Index (EASI)
时间窗: 3 weeks
A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72
次要结局
- Interim Eczema Area and Severity Index (EASI)(Week 2)
- Assessment of Itch(through Week 3)
- Investigator's Global Atopic Dermatitis Assessment (IGADA)(through Week 3)