The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Eczema Area and Severity Index (EASI) score improvement from baseline
研究概览
简要总结
To evaluate the efficacy of water bath, water + bleach, and water + vinegar (acetic acid) in the treatment of atopic dermatitis (eczema)
详细描述
To perform a randomized controlled study to evaluate the efficacy of adding dilute acetic acid to the bath twice weekly on the Eczema Area and Severity Index (EASI) score as compared to adding dilute bleach to the bath including a control arm in which no solution is added to the bath.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently reside in the USA
- •Ability to comply with follow up visits at 2-4 months and at 6 months
- •Come to the last follow-up at 6 months in the clinic
- •At least 5% Body Surface Area (BSA) affected with AD
排除标准
- •Unclear diagnosis of atopic dermatitis
- •Inability to comply with additive baths
- •Inability to comply with follow-up visits
- •Lack of residence in the United States
结局指标
主要结局
Eczema Area and Severity Index (EASI) score improvement from baseline
时间窗: At each visit until the last visit at 6 months
The EASI score is a validated composite score that ranges from 0 (clear) to 72 (very severe). The EASI is assessed and calculated as: the proportion of affected body surface area (BSA) was estimated from 4 designated body regions (head/neck, upper limbs, trunk, and lower limbs), and the Physician's Assessment of Individual Signs was determined for each region. The Physician's Assessment of Individual Signs grades signs of AD (erythema, edema/induration/papulation, excoriation, oozing/weeping/crusting, scaling, and lichenification) on a 4-point scale, ranging from absent to severe. Both the proportion of affected BSA and the Physician's Assessment of Individual Signs score are used to calculate the EASI score.
次要结局
- Children's Dermatitis Quality of Life Index (CDQLI) for children at 4 years old or greater(At each visit until the last visit at 6 months)
- Changes in Investigator's Global Assessment (IGA) score from baseline(At each visit until the last visit at 6 months)
- Patient Oriented Eczema Measure (POEM)(At each visit until the last visit at 6 months)
- Presence of staphylococcus aureus on involved skin(At each visit until the last visit at 6 months)
- Rate of oral antibiotic prescribing(At each visit until the last visit at 6 months)
- Infant Dermatitis Quality of Life (IDQOL) for children under 4 years old(At each visit until the last visit at 6 months)
- Frequency and severity of atopic dermatitis flares(At each visit until the last visit at 6 months)
- pH of the skin(At each visit until the last visit at 6 months)
研究者
Megha M. Tollefson, M.D.
Principal Investigator
Mayo Clinic