NCT00354510已完成2 期
Randomised, Double-blind, Placebo-controlled Study of Topical GW842470X Formulation in Adults With Moderate Atopic Dermatitis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 14
- 主要终点
- Clinical efficacy of 3% GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema Area Severity Index (EASI).
研究概览
简要总结
The purpose of this study is to investigate the clinical efficacy of 3% (w/w) GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema Area Severity Index (EASI) assessment of disease severity and to investigate the safety of and tolerability of 3% GW842470X cream on diseased skin of adult patients.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate atopic dermatitis patients (IGA=3).
- •The disease involvement must be >5% of body surface area.
- •Female patients of child-bearing potential must use an appropriate method of contraception.
排除标准
- •Patients with any active skin disease other than atopic dermatitis will not be eligible.
- •Patients who have had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies) within 14 days prior to first application of study medication and/or topical treatment with tar, any corticosteroid, topical immunomodulators or oral treatment with any corticosteroids within 10 days prior to first application and/or oral anti-histamines within 5 days of the first dose.
结局指标
主要结局
Clinical efficacy of 3% GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema Area Severity Index (EASI).
次要结局
- Safety and tolerability of 3% GW842470X cream
- Clinical efficacy using SCORing Atopic Dermatitis score & Investigators Global Assessment Scale
- Symptoms: pruritus & sleep loss
- Characterize systemic exposure to GW842470X following 21 days treatment.
研究者
研究点 (14)
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