The Effects of Superfine Merino Wool in the Management of Childhood Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
研究概览
简要总结
The study is a sequentially recruited, cross-over-cohort, outpatient-based evaluation of the effectiveness of wool clothing, as compared to standard clothing, in reducing the severity of childhood atopic dermatitis over two consecutive six-week periods.
详细描述
The study will aim for a sample size of approximately 40 patients between the ages of 0 and 3 years of children referred to the Dermatology Department at the Royal Children's Hospital for management of mild to moderate atopic dermatitis. They will be sequentially recruited and randomized to the wool-standard clothing arm or standard clothing-wool arm.
The study will run for 12 weeks for each participant with two 6-week periods, either of wool followed by standard clothing or standard followed by wool clothing. Participants will be assessed by a blinded trained researcher during this time, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks.
The primary outcome is change in the severity of atopic eczema at 6 weeks. Severity of atopic eczema will be measured using the Scoring Atopic Dermatitis (SCORAD) index.
Secondary outcomes include the change in the severity of eczema using the SCORAD at 3 weeks and the Atopic Dermatitis Severity Index (ADSI) score at 3 and 6 weeks and quality of life assessment using the Dermatology Life Quality Index (DLQI) at 3 and 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild to moderate eczema as determined by a SCORAD of 1-50 at their initial visit
- •has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf
- •is capable of returning for review having had education through the Royal Children's Hospital eczema workshop
排除标准
- •known reactions to wool products
- •is unable to attend visits
- •has unstable eczema defined by treatment escalation or increased topical anti-inflammatory use in the preceding 2 months
结局指标
主要结局
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
时间窗: at 6 weeks
blinded assessor administered SCORAD
次要结局
- Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)(at 3 weeks)
- Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)(at 3 weeks)
- Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)(at 3 weeks)