Prospective, randomized, non-treatment controlled, investigator-blinded, multicenter study on the prophylaxis of early childhood symptoms of atopic dermatitis in high-risk children by continuous continuous application of a moisturizing barrier-stabilizing skin cream
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 11
- 主要终点
- The primary end point is defined as the cumulative incidence of atopic dermatitis (AD) at the age of 6 months. AD is confirmed if in at least 2 examinations at an interval of at least 4 weeks (initial diagnosis + evidence of chronification) an AD is diagnosed. A confirmed AD is abbreviated as "AD" in the context of the study (this does not refer to the initial detection of AD symptoms).
研究概览
简要总结
The MOPAD study aims to evaluate the clinical efficacy of the SanaCutan Basiscreme by comparing the cumulative incidence of atopic dermatitis (AD) in infants with high familial risk between the treatment group and the control group (without treatment) at the age of 6 months. A clinical efficacy (primary objective) is achieved if the cumulative AD incidence in the treatment group at the age of 6 months is significantly lower than in the control group (p < 0.05). AD is confirmed if in at least 2 examinations at an interval of at least 4 weeks (initial diagnosis + evidence of chronification) an AD is diagnosed. A confirmed AD is abbreviated as “AD” in the context of the study (this does not refer to the initial detection of AD symptoms).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Healthy newborns (male or female)
- •Age < 3 weeks (≤ 21st day of life)
- •High familial risk of atopic dermatitis with at least one 1st degree relative (parent or sibling) with a history of medically diagnosed atopic dermatitis
- •Written declaration of consent from all legal guardians
排除标准
- •Acute or chronic diseases
- •Limited legal capacity of the guardians
- •Inability of the guardians to understand the study instructions
- •Obvious unreliability or lack of cooperation of the guardians
- •Known alcohol, medication or drug addiction of the guardians
- •Dependence of the child or guardian on the sponsor or investigator
- •Previous participation in another clinical trial (since birth)
- •Previous participation in this study
- •Acute fever (> 38.5 °C)
- •Serious congenital malformations
- •Hydrops fetalis
- •Immunodeficiency (of any kind)
- •Serious genetic skin diseases or skin conditions that make the use of skin creams unsuitable
- •Corticosteroid or calcineurin inhibitor use or taking cyclosporine
- •Prematurity (< 37 weeks)
- •Known hypersensitivity to any of the ingredients of SanaCutan Basiscreme
结局指标
主要结局
The primary end point is defined as the cumulative incidence of atopic dermatitis (AD) at the age of 6 months. AD is confirmed if in at least 2 examinations at an interval of at least 4 weeks (initial diagnosis + evidence of chronification) an AD is diagnosed. A confirmed AD is abbreviated as "AD" in the context of the study (this does not refer to the initial detection of AD symptoms).
The primary end point is defined as the cumulative incidence of atopic dermatitis (AD) at the age of 6 months. AD is confirmed if in at least 2 examinations at an interval of at least 4 weeks (initial diagnosis + evidence of chronification) an AD is diagnosed. A confirmed AD is abbreviated as "AD" in the context of the study (this does not refer to the initial detection of AD symptoms).
次要结局
- Adverse events: overall frequency, type, severity, causality, with frequencies, separate presentation of local reactions up to 6 and 12 months of age
- Drop-outs (with reasons) up to 6 and 12 months of age
- Cumulative incidence of children with AD at 12 and 16 weeks, 9, 12 and 6-12 months
- Cumulative incidence of children with preliminary diagnosis of atopic dermatitis (regardless of whether chronification is confirmed at 12 and 16 weeks, 6, 9 and 12 months of age
- Time to onset of AD at 0-6, 6-12 and 0-12 months of age
- Cumulative incidence and frequency of children with xerosis at 6 and 12 months of age
- Cumulative incidence and frequency of children with signs of itching at 6 and 12 months of age
- Cumulative incidence and frequency of children with eczema of other types at 6 and 12 months of age
- Severity of AD at the time of detection of (confirmed) AD up to 12 and 16 weeks and 6, 9 and 12 months of age
- Frequency of sensitization to food allergens (according to Fx5 test + hazelnut) and to inhalation allergens (according to Sx1 test) and total IgE at the age of 6, 9 and 12 months
- Compliance regarding the use of the investigational medicinal product in the treatment group up to the age of 6, 12 and 6-12 months
- Compliance regarding the use of other skin care products (not investigational medicinal product) in both groups up to the age of 6, 12 and 6-12 months
研究者
InfectoPharm
Scientific
INFECTOPHARM Arzneimittel und Consilium GmbH