A Prospective Randomized Open-label Controlled Study to Assess Whether Daily Application of Skin Moisturizer Containing Acemannan Hydrogel From Birth Can Prevent Atopic Dermatitis in Children
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Cumulative incidence of AD at twelve months of age in the intervention group compared to the control
研究概览
简要总结
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disorder associated with a decreased ability of the skin to function as an efficient immunological barrier. The disease is now two to three times more prevalent in children than it was just four decades ago. It is manifested by eczematous skin lesions associated with severe itch, leading to a significant impairment in quality of life. Of additional importance, AD oftentimes progresses to allergic rhinitis and/or asthma, a process referred to as the "atopic march." Recent reports have indicated that daily application of moisturizing creams on neonates and infants can prevent the occurrence of AD and subsequently food allergies. This is postulated to be the outcome of restoring the barrier integrity of the skin through the daily application of moisturizer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 24 Hours 至 120 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A healthy newborn delivered in a hospital setting more than 24 hours prior to enrollment & less than 120 hours prior to enrollment
- •Average forearm TEWL reading of >8.50 g/m2
- •Mothers must be aged >18 years
- •Parents' ability to complete questionnaire(s) at defined times throughout study duration
- •Parents or legal guardian provide informed written consent
排除标准
- •Preterm birth (birth prior to 37 weeks gestation)
- •Neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days
- •Neonate has an existing widespread skin condition that would make the detection and/or assessment of eczema difficult
- •Neonate has been administered oral or parenteral antibiotics from birth until study enrollment
- •Neonate has a serious health issue which, at parent or investigator discretion, would make it difficult for the neonate or parents to take part in the trial
- •Any conditions which precludes the daily application of moisturizing lotion
- •Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety
结局指标
主要结局
Cumulative incidence of AD at twelve months of age in the intervention group compared to the control
时间窗: 12 months
Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist
次要结局
- Cumulative incidence of AD at six months of age in the intervention group compared to the control(6 months)
- Timing of onset of AD in the intervention group compared to the control(12 months)
- Cumulative incidence of food allergies at 24 months of age in the intervention group compared to the control(24 months)
- Cumulative incidence of AD at 24 months of age in the intervention group compared to the control(24 months)
- Severity of AD in the intervention group compared to the control(12 months)
- Cumulative incidence of food allergies at 12 months of age in the intervention group compared to the control(12 months)