Efficacy of the V0034CR01B Emollient on Xerosis in Children With Atopic Dermatitis. Randomised, Vehicle-controlled, Parallel-groups, Double-blind Study With an Open Label Extension.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 5
- 主要终点
- Xerosis score: mean evolution over the different time-points of double-blind period
研究概览
简要总结
Atopic dermatitis is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of atopic dermatitis are dry skin, intense pruritus and impaired epidermal barrier function. Atopic dermatitis is associated with skin barrier dysfunction that facilitates an easier allergen penetration into the skin with an increased irritation and subsequent cutaneous inflammation. A lack of important stratum corneum intercellular lipids and an inadequate ratio between compounds enhance trans-epidermal water loss leading to xerosis. Skin hydration by emollient therapy usually twice daily improves dryness and subsequently pruritus during the treatment of atopic dermatitis and especially improves the barrier function. Emollients make part of basic therapy (grade 1) for treatment of atopic dermatitis (European Academy of Dermatology and Venereology Task Force 2009 Position Paper). Improvement of cutaneous barrier alteration, measured by skin hydration, is a key element for evaluation of emollient treatment efficacy.
The primary objective of this study is to demonstrate the efficacy of the tested product (V0034CR01B) cream on xerosis in children with atopic dermatitis compared to the excipient formula during 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
- Double (Participant, Investigator)
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
- •Presenting with atopic dermatitis, dry skin, objective SCORAD < 15,
- •With xerosis on the body and a xerosis score > = 2 (SCORAD sub-score) on the anterior part of lower limbs,
排除标准
- •Acute phase of atopic dermatitis
- •Severe form of atopic dermatitis
研究组 & 干预措施
V0034CR01B
干预措施: V0034CR01B (Drug)
V0034CR01B
干预措施: desonide 0.1% cream (Drug)
V0034CR01B
干预措施: Foaming gel (Other)
Vehicle cream
干预措施: Vehicle cream (Drug)
Vehicle cream
干预措施: desonide 0.1% cream (Drug)
Vehicle cream
干预措施: Foaming gel (Other)
结局指标
主要结局
Xerosis score: mean evolution over the different time-points of double-blind period
时间窗: During 28 days (Day 1, Day 7, Day 14, Day 21 and Day 28)
次要结局
- Hydration Index score : measurement of the skin hydration(Day 1, Day 14, Day 28, Day 56 and Day 84)
- Xerosis score evolution over the different time-ponts during open label period(At Visit1 (Day 1) and at Day 56 and Day 84)
- Xerosis Visual Analogue Scale (evaluation skin dryness)(Day 1, Day 14, Day 28, Day 56 and Day 84)
- Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis.(Day1, Day 28, Day 56 and Day 84.)
- Overall assessment of treatment efficacy by the investigator(Day 28 and Day 84)
- Overall assessment of treatment efficacy and use by the parent(s)/guardian(s)(at Day 28 and at Day 84)
- Assessment of the local tolerability and the systemic safety (reported adverse events)(Day 1, Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84)
- Topical corticosteroid assessment(Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84)