Accessible and Affordable Moisturizers for Atopic Eczema: the 2am Atopic Eczema Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in the validated SCORing Atopic Dermatitis(SCORAD)
研究概览
简要总结
Aqueous (EUA) cream, cetomacrogol (CMG) and emulsifying ointment (HEB) are in South Africa's essential drug list (EDL) but are not available to most rural patients. To assess whether accessible moisturizers can be used as alternatives in atopic eczema (AD), a randomized controlled trial of patients with mild-to-moderate AD, aged 1-12 years was conducted. Two separate sub-studies were conducted using a randomized controlled single (assessor) blind trial design. Study 1 compared UEA vs. liquid paraffin (unscented baby oil) for baths, all patients used HEB as moisturiser. In Study 2, 4 moisturisers were compared -HEB, CMG, petroleum jelly and petroleum jelly/Glycerine (2:1). Assessments (SCORAD, POEM, NESS and IQDOL) carried out at baseline, week 4, 8 and 12. Routine topical steroids and antihistamines were continued as prescribed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Atopic dermatitis as defined by the united kingdom (UK) Working party Diagnostic Criteria
- •Atopic Dermatitis patient with mild to moderate stable atopic eczema with parents/guardians willing and able to apply study moisturizers as directed and commit to attend all visits.
排除标准
- •Less than 1 year of age
- •Patients with atopic dermatitis treated with systemic preparations
结局指标
主要结局
Change in the validated SCORing Atopic Dermatitis(SCORAD)
时间窗: Baseline, week 4, 8 and week 12
Change in the validated SCORing Atopic Dermatitis(SCORAD) and two other validated clinical scores (Nottingham Atopic Eczema Severity Score(NESS) and Patient Oriented Eczema Measure(POEM) were used to measure the extent/severity of AD. A validated quality-of-life form using the infants dermatitis quality of life (IDQOL) scale was completed by each care-giver at each visit.
次要结局
- Change in the patient quality-of-life as measured by the infants dermatitis quality of life (IDQOL) index at each visit.(Baseline, week 4, 8,12)
研究者
Dr Carol Hlela
Dermatologist
Red Cross War Memorial Childrens Hospital