Comparative Clinical Trial Between LimpiAD 2.5% Plus Cream, Its Vehicle and a Basic Emollient in Atopic Dermatitis in Paediatric Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Change in Eczema Area and Severity Index (EASI)
研究概览
简要总结
The purpose of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the formulation of a 2.5% Plus cream, versus the Vehicle of LimpiAD 2,5% Plus cream, and versus a basic emollient in subjects with mild to moderate Atopic Dermatitis.
详细描述
The objective of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the formulation of 2.5% Plus cream, versus the Vehicle of LimpiAD 2,5% Plus cream , and versus a basic emollient in subjects with mild to moderate Atopic Dermatitis.
STUDY DESIGN A controlled, 3-arms randomized, double-blind, multicentre clinical trial within subjects, stratified and balanced based on severity of the Atopic Dermatitis (AD) between LimpiAD 2.5% Plus cream, the Vehicle of LimpiAD 2.5% Plus cream and a basic standard treatment (basic therapy) of AD according to European Guidelines in pediatric subjects with mild to moderate AD.
SAMPLE SIZE Two hundred (200) subjects with Atopic Dermatitis, of whom at least 50 cases with mild severity Atopic Dermatitis (defined by EASI = Eczema Area and Severity Index = 1.0-7.0 and IGA= Investigator's Global Assessment =2) and 50 cases with moderate severity Atopic Dermatitis (defined by EASI 7.1-21.0 and IGA=3).
TREATMENT SCHEDULE AND METHODS Treatment with the investigational product or the control products will occur twice daily (morning and evening) for 8 weeks after cleansing of the treatment area. After the 8 weeks treatment period, the study subjects will undergo a follow-up visit after 12 weeks following the baseline visit (4 weeks after treatment completion).
Clinical assessments will be performed at baseline (T0), and after 2, 4, 8 and 12 weeks (T2, T4, T8 and T12) by means of a daily diary as a reminder.
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
- 6 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both sexes, between 6 months and 16 years of age, Caucasian, in good health, whose parents/tutors provided a written and signed informed consent for participation in the study shall be enrolled. In particular, as regards parents/tutors:
- •Both parents/tutors, in case of joint custody, must provide a written and signed informed consent for the participation of the child in the study according to the instructions provided by the investigators;
- •They must accept to bring the child to the clinical trial facility on predefined visit days according to the instructions provided by the investigators;
- •They must be willing and be able to follow the trial requirements provided by the investigators.
- •The inclusion criteria provide that:
- •Symptoms and signs compatible with a clinical diagnosis of Atopic Dermatitis should be present upon enrollment;
- •The clinical severity of AD should correspond to an EASI ranging between 1.0 and 21.0 and an IGA equal to 2 or 3;
- •Pruritus severity assessed by means of VAS scale ≥ 4 cm should be referred to the part of the body to be treated, as a requirement for inclusion in the study;
- •The clinical assessment should envisage for the patient the indication of a moisturizing/emollient treatment as single therapy for AD (in accordance with European Guidelines on AD treatment).
排除标准
- •The following items are to be considered as exclusion criteria:
- •The application of cortisone-based products on the skin to be treated in the 2 weeks prior to treatment;
- •Ongoing use at baseline of antibiotics and systemic anti-inflammatory drugs for AD in the 2 weeks preceding treatment and during the study (paracetamol is allowed at dosages and indications recommended for use as an antipyretic and analgesic);
- •Baseline treatment with anti-inflammatory drugs, antihistamines, antitussives and/or inhaled steroids in the 2 previous weeks, retinoids and/or immunosupressants in the previous 6 months.
- •Use of systemic steroids in the 4 weeks prior to the study.
- •Intense and prolonged sun exposure in the 30 days preceding the screening.
- •Severe AD (EASI > 21) or mild/moderate AD requiring any local and/or systemic treatment comprised in the prohibited treatments included in the exclusion criteria;
- •Hypersensitivity to the study products.
- •Acute or chronic skin diseases - except for atopic eczema - which may invalidate clinical assessments or overlap with AD skin picture;
- •Systemic diseases which may affect the subject's safety or wellbeing or interfere with skin response.
结局指标
主要结局
Change in Eczema Area and Severity Index (EASI)
时间窗: Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
The change shall be calculated by comparing the baseline value (T0) with the 2 weeks (T4), 4 weeks (T4) and 8 weeks (T8) values of LimpiAD 2.5% Plus cream versus the Vehicle of LimpiAD 2.5% Plus cream in terms of: - score reduction detected (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
- Eczema Area and Severity Index (EASI) Change(Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8))
- Change in extension and signs intensity of the target areas,(Baseline (T0),2 weeks (T2), 4 weeks (T4) and 8 weeks (T8))
- Change in Investigator Global Assessment (IGA) scale for Atopic Dermatitis(Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8))
- Change in pruritus(Baseline (T0), 4 weeks (T4) and 8 weeks (T8))
- Change in sleep(Baseline (T0), 4 weeks (T4) and 8 weeks (T8))
- Children's Dermatology Life Quality Index (CDLQI) questionnaire(Baseline (T0),2 weeks (T2), 4 weeks (T4) and 8 weeks (T8))