NCT01286220终止不适用
A Randomized, Controlled, Evaluator-blinded Study to Evaluate the Efficacy of Dilute Bleach Baths on Skin Disease Control in Pediatric Patients With Atopic Dermatitis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Eczema Area and Severity Index Score (EASI)
研究概览
简要总结
The purpose of this study is to determine if twice weekly 10 minute dilute bleach baths decreases disease severity in patients with moderate to severe atopic dermatitis.
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
- Double
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2-17 years of age at time of consent. A parent or legal guardian will be required to consent and authorize their enrollment in the study.
- •Male or female of any ethnic background.
- •English or Spanish speaking.
- •A clinical diagnosis of atopic dermatitis for at least 6 months prior to enrollment.
- •Must have moderate to severe atopic dermatitis as rated by the EASI score.
- •Able to adhere to study visit schedule and other protocol requirements.
- •Patients and/or family members must agree to not use any other prescription or over the counter medications other than the ones prescribed by the study protocol.
排除标准
- •Clinical evidence of bacterial or viral superinfection on first visit.
- •Have received phototherapy within 2 months prior to enrollment.
- •Have received any systemic medication for atopic dermatitis or any that may affect evaluation of atopic dermatitis within 2 months prior to enrollment.
- •Have a known hypersensitivity response, including anaphylaxis, to any of the topicals used for treatment (i.e. topical steroids, bleach)
- •Participation in another clinical trial using an investigational agent or procedure.
- •Pregnant or planning pregnancy or surgery during the participation in the study.
研究组 & 干预措施
Dilute bleach baths
Active Comparator
Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.
干预措施: Dilute bleach baths (Other)
Water
Placebo Comparator
Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.
干预措施: Water (Other)
结局指标
主要结局
Eczema Area and Severity Index Score (EASI)
时间窗: Change in EASI score from baseline at 1 month and 3 month follow ups
EASI score is recorded at baseline, 1 month and 3 month follow ups.
次要结局
- Investigator's Global Assessment (IGA)(Change in IGA score from baseline at 1 month and 3month follow ups)
研究者
研究点 (1)
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