Bleach vs. Bubbles: Assessing the Impact of the Bathroom Environment on Eczema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Absolute change in POEM score From Baseline (day 0) to Week 4 (day 28)
研究概览
简要总结
Purpose: Evaluate the impact of cleaning the bathroom environment on the severity of eczema. Determine if part of the efficacy of bleach baths may be in cleaning the bathroom. Record data on the process in order to improve future interventions.
Participants: Patients and families with eczema
Procedures (methods):
- Obtain baseline eczema severity scores and bacterial cultures from bathtubs
- Randomize subjects to receive (1) a bathtub culture alone; (2) a culture and bathroom cleaning; and (3) a culture, cleaning, and bleach baths.
- Measure changes in eczema severity scores over 4 weeks
- Qualitatively evaluate the process by participants and investigators
详细描述
The study will evaluate the effect of two interventions.
- At the start of the study, two-thirds of the patients (40 patients) will be randomized to have a culture taken from their bathtub with subsequent cleaning of all of their bathrooms (intervention arm) versus one-third (20 patients) only obtaining a culture taken from their bathtub with no cleaning (control arm).
- After cleansing the bathrooms in the intervention arm, this group will be randomized again so that half of this group (20 patients) receives instructions on performing twice weekly bleach baths and the other half (20 patients) does not.
- When the intervention period ends at 4 weeks, the placebo arm will be offered a bathroom cleaning.
There will be four quantitative assessment phases:
- Upon entry into the study the investigators will obtain basic demographic information (insurer, age, race/ethnicity), a history of skin infections and allergic diseases, an eczema severity score (POEM score), an eczema area and severity index score (EASI score), and record the participant's level of eczema therapy (weak-moderate topical steroids, strong topical steroids, or systemic immunomodulators).
- The investigators will obtain a culture from the bathtub used by every study subject. This will be prior to cleaning the bathroom if the participant is in the cleaning intervention arm.
- The investigators will obtain a POEM score over the phone 1 week after obtaining the cultures.
- After 4 weeks, the investigators will obtain a POEM score over the phone as well as document whether the participant received any antibiotics or had any visits to medical providers for atopy flares over the last 4 weeks. The investigators will also re-record the participant's level of eczema therapy (weak-moderate topical steroids, strong topical steroids, or systemic immunomodulators).
There will be one qualitative assessment:
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
- Single (Investigator)
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
- •Children with eczema who visit UNC pediatric dermatology during study enrollment (Summer 2018).
- •Currently on a class 1 topical steroid or systemic immunosuppressive agent to control his/her eczema at the time of recruitment.
- •A history of, or current clinical evaluation by the attending dermatologist showing, atopic dermatitis affecting at least 10% body surface area.
排除标准
- •Child or family member with a sensitivity to bleach.
- •Child has used bleach baths within the last 2 months.
结局指标
主要结局
Absolute change in POEM score From Baseline (day 0) to Week 4 (day 28)
时间窗: Baseline (day 0) to Week 4 (day 28)
POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease). A higher POEM score correlates with a poorer quality of life (QOL).
次要结局
未报告次要终点
