Emollients in the Management of Atopic Dermatitis in Children: Prevention of Flares.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 347
- 主要终点
- Percentage of patients with at least one flare over the treatment period
研究概览
简要总结
The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.
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
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 2 and 6 years included,
- •Presenting with atopic dermatitis, with at least one duly documented flare treated by corticosteroids within the previous 6 months, and presenting a current flare (objective Scoring for Atopic Dermatitis (SCORAD score) is [15-40] at inclusion),
- •After treatment of the current flare, patients should have for randomization an Objective SCORAD score < 15, with Xerosis intensity≥ 1 and no subjective signs
排除标准
- •Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation,
- •Primary bacterial, viral, fungal or parasitic skin infection,
- •Ulcerated lesions, acne or rosacea,
- •Dermatological disease other than atopic dermatitis which could interfere with the assessment,
- •Immunosuppression,
研究组 & 干预措施
Group 1
glycerol, paraffin (liquid and white soft), Locatop@
, Locapred@
干预措施: Locapred@ (Drug)
Group 2
Active control arm, Locatop@, Locapred@
干预措施: Atopiclair® (Device)
Group 2
Active control arm, Locatop@, Locapred@
干预措施: Locatop@ (Drug)
Group 1
glycerol, paraffin (liquid and white soft), Locatop@
, Locapred@
干预措施: Locatop@ (Drug)
Group 2
Active control arm, Locatop@, Locapred@
干预措施: Locapred@ (Drug)
Group 3
Absence of emollient treatment, Locatop@, Locapred@
干预措施: Locatop@ (Drug)
Group 3
Absence of emollient treatment, Locatop@, Locapred@
干预措施: Locapred@ (Drug)
Group 1
glycerol, paraffin (liquid and white soft), Locatop@
, Locapred@
干预措施: glycerol, paraffin (liquid and white soft) (Drug)
结局指标
主要结局
Percentage of patients with at least one flare over the treatment period
时间窗: 12 weeks of treatment.
A flare is defined as following: measurable increased extend or intensity of lesions in less than 2 weeks under continued treatment corresponding to a significant increase in medical score (\> 25%) or to the introduction of a new line of therapy(topical corticosteroid).
次要结局
未报告次要终点