Clinical Comparison of LimpiAD Cream 2.5% Plus, Vehicle and an Emollient in Pediatric Patients With Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Change in Eczema Area and Severity Index (EASI)
研究概览
简要总结
The purpose of this randomized clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the form of a 2.5% Plus cream, as compared to the Vehicle of LimpiAD 2.5% Plus cream and a standard emollient used as neutral control, which represents the basic standard treatment (basic therapy) of AD according to European Guidelines in pediatric subjects with mild to moderate Atopic Dermatitis.
详细描述
The purpose of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the form of a 2.5% Plus cream, as compared to the Vehicle of LimpiAD 2.5% Plus cream and a standard emollient used as neutral control, which represents the basic standard treatment (basic therapy) of AD according to European Guidelines in pediatric subjects with mild to moderate Atopic Dermatitis.
This is a randomized, double-blind, multicenter, stratified, clinical trial of the medical device LimpiAD 2.5% Plus cream versus the vehicle of this medical device and versus an emollient in pedriatic Atopic Dermatitis patients that will be randomized in a 2:2:1 fashion to the compound mentioned above.
The study aims to enrol two hundred (200) pediatric subjects of both sexes, with an age ranging between 2 years old and 16 years old with atopic dermatitis of which at least 50 with mild severity (EASI 1.0-7.0 and IGA = 2) and 50 cases with moderate severity (EASI 7.1-21.0 and IGA = 3).
The treatment with the study product or with the control products shall be performed twice daily (morning and evening) after cleansing, for 4 weeks.
Clinical assessments shall be performed at baseline (T0) and after 2 and 4 weeks (T2 and T4) by means of a daily reminder diary.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Eczema Area and Severity Index (EASI)
时间窗: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
The change shall be calculated by comparing the baseline value (T0) with the corresponding value at 4 weeks (T4) for LimpiAD cream 2,5% Plus versus the Vehicle of LimpiAD cream 2,5% Plus in terms of detected score reduction (total EASI score). INTERPRET EASI: Clear 0; Almost clear 0.1-1.0 ; Mild 1.1-7.0 ; Moderate 7.1-21.0 ; Severe 21.1-50.0; Very severe 50.1-72.0
次要结局
- Change in Investigator Global Assessment (IGA) scale for Atopic Dermatitis(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Eczema Area and Severity Index (EASI) Change(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Change in extension and signs intensity of the target areas(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Children's Dermatology Life Quality Index (CDLQI) questionnaire(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Functional recovery(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Change in pruritus at the 4 week (T4)(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Microbial balance(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Change in sleep at 4 weeks (T4)(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))