NCT00654355已完成4 期
Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.
详细描述
To evaluate adherence to topical therapy using adherence data collected by the MEMS cap (Medication Electronic Monitoring System) in pediatric patients with atopic dermatitis (AD) and the impact of a return visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects age 2-
- •Stable or worsening atopic dermatitis affecting 5% or greater body surface area. Face and genital areas can be included in the body surface area determination and treatment area.
- •The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- •The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment.
排除标准
- •Known allergy to tacrolimus or to any component of the formulations.
- •The use of systemic therapy for atopic dermatitis within the past 4 weeks.
- •Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or retinoids) within the past 2 weeks.
- •Use of any investigational therapy within the past 4 weeks.
- •Pregnant females, females who are breast feeding, or females of childbearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study. A pregnancy test will be performed on females of childbearing potential at baseline and at week
- •Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
研究组 & 干预措施
Active Drug
Experimental
tacrolimus ointment
干预措施: tacrolimus ointment (Drug)
结局指标
主要结局
Adherence
时间窗: Week 4
adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed
次要结局
- EASI(Week 4)
- The % Change From Baseline to Week 4 (or End of Treatment) in the IGA.(Week 4)
研究者
研究点 (1)
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