Effect of Cetaphil® Restoraderm® Moisturizer on Very Dry Skin in Children With a Controlled Atopic Dermatitis:a Randomised, Parallel Group Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Time to Relapse (Quantile 25%)
研究概览
简要总结
The purpose of this study is to evaluate the effect of Cetaphil® Restoraderm® skin restoring moisturizer in reducing the signs and symptoms of very dry atopic skin in young children. Subjects with atopic dermatitis (AD) in remission phase will be randomized to receive either Cetaphil® Restoraderm® skin restoring body wash only, or the same body wash in association with Cetaphil® Restoraderm® skin restoring moisturizer.
详细描述
Two groups randomized in a ratio of [1:1] for a 12-week period Five study evaluation were planned: at Baseline, week 2, Week 4, Week8 and Week12
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject, aged 2 to 12 years inclusive
- •Controlled mild to moderate atopic dermatitis with a Investigator Global Assessment score at 0 or 1, within one week after successful treatment with topical corticosteroid.
排除标准
- •Subject presenting bacterial, viral, fungal or parasite skin infection
- •Subject with ulcerated lesions, acne or rosacea
- •Immunosuppression
- •Subject with a wash-out period from baseline for topical treatment less than 8 days for Calcineurin inhibitor
- •Subject with a wash-out period from baseline for topical treatment more than 8 days for corticosteroid
- •Subject with a wash-out period from baseline for systemic treatment less than 8 days for anti-histamines, less than 4 weeks for immunomodulators
研究组 & 干预措施
Moisturizer + Body wash
Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)
干预措施: Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash (Other)
Body wash
Cetaphil® Restoraderm® body wash (1/day)
干预措施: Cetaphil® Restoraderm® body wash (Other)
结局指标
主要结局
Time to Relapse (Quantile 25%)
时间窗: The duration between Baseline and the first AD relapse occurred (up to 89 days)
Time to relapse corresponds to date of relapse - date of baseline. Quantile 25% replaced the median time to relapse that was not reached.
次要结局
未报告次要终点