临床试验/NCT01675232

NCT01675232已完成不适用

A Randomized, Investigator-Blinded Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis

Yale University2 个研究点分布在 1 个国家目标入组 45 人开始时间: 2012年7月最近更新: 2014年7月29日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Yale University
入组人数: 45
试验地点: 2
主要终点: Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to investigate the efficacy of two different corticosteroid ointment application regimens for the treatment of eczema (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: Single (Investigator)

入排标准

年龄范围: 2 Weeks 至 18 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Meet the clinical criteria for the diagnosis of atopic dermatitis
•Have disease over at least 5% of their total body surface area.
•Less than 18 years of age.
•Families able to comprehend written instructions in English and able to complete questionnaires with assistance if needed.
•Parents/guardians able to understand and willing to sign a parental permission form.
•Children between the ages of 7-17 years willing to sign an age-appropriate assent form.

排除标准

•Patients who are allergic or intolerant of the topical medications employed in this study.
•Lack of follow-up after initial visit or regimen noncompliance.
•Patients who do not have access to a bathtub.

结局指标

主要结局

Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)

时间窗: 2 weeks

次要结局

Adverse effects associated with each corticosteroid application regimen(3 months)
Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen(3 months)
Effect of corticosteroid ointment application regimens on serum cortisol(2 weeks after application of topical corticosteroids)

研究者

发起方

Yale University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Richard Antaya

Professor of Dermatology and Pediatrics

Yale University

研究点 (2)

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