Determining Effects of Superfine Sheep Wool in INfantile Eczema (DESSINE 2): a Multicentre Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Eczema Area and Severity Index (EASI)
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 (eczema) over two consecutive six-week periods.
详细描述
The study will aim for a sample size of approximately 150 participants (equally distributed between 3 international sites) between the ages of 3 months and 5 years referred to the respective Dermatology Departments for management of moderate to severe atopic dermatitis. They will be sequentially recruited and randomized to the wool-to-standard clothing arm or standard clothing-to-wool arm.
The study will run for 12 weeks for each participant with two consecutive 6-week periods for each intervention, either of wool followed by standard clothing or standard followed by wool clothing. Participants will be assessed by a blinded trained researcher, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks post commencement of the first intervention.
The primary outcome is the severity of atopic dermatitis at 6 weeks post commencement of each intervention i.e.at week 6 and week 12. Severity of atopic eczema will be measured using the Eczema Area and Severity Index (EASI).
Secondary outcomes include the severity and change in the severity of eczema using the EASI at 3 weeks, the validated Investigators Global Assessment for atopic dermatitis (vIGA-AD™) score and quality of life assessment using the children's Dermatology Life Quality Index (cDLQI) at 3 and 6 weeks of each 6 week intervention period, as well as weekly Patient Oriented SCORing Atopic Dermatitis index (PO-SCORAD) scores.
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
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is aged between 3 months and 5 years of age at the time of recruitment
- •Has moderate to severe eczema as determined by an EASI score of 7 or above at their initial visit
- •Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf
排除标准
- •Has a known allergic contact dermatitis to wool or merino wool
- •Is unable to attend all scheduled visits
- •Has unstable eczema defined by an escalation of treatment requirements during the preceding 6 weeks. This would include flares of AD for any reason including infection, food allergy etc.
- •Use of systemic corticosteroids within 6 weeks of study start.
- •Any medical reason that is considered by the principal investigator to preclude enrolment.
结局指标
主要结局
Eczema Area and Severity Index (EASI)
时间窗: week 3 of each 6 week period (ie week 6 and 12)
blinded assessor administered EASI (units on a scale), will assess change from baseline. A score is obtained ranging from 0-72 based on erythema, papulation, excoriation and lichenification, each graded 0-3 for each of four body regions (head and neck, upper limbs, trunk, lower limbs) that are weighted according to surface area representation. A higher number indicates increased severity.
次要结局
- children's Dermatology Life Quality Index (cDLQI)(week 3, 6, 9, 12)
- Topical medication use(daily over 12 weeks)
- Patient Oriented SCORing Atopic Dermatitis score (PO-SCORAD)(weekly over 12 weeks)
- Topical moisturiser use(weekly over 12 weeks)
- Eczema Area and Severity Index (EASI)(week 3 of each 6 week period (ie week 3 and 9))
- validated Investigators Global Assessment for atopic dermatitis (vIGA-AD™) score(week 3, 6, 9, 12)