NCT00436540已完成4 期
A Comparison Between Clobetasol Propionate (Clobex®) Spray and Clobetasol Propionate (Olux®) Foam With Regard to Efficacy, Safety, Preference and Duration of Response in Stable Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Efficacy - Body Surface Area, Investigator Global Severity
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of clobetasol propionate 0.05% (Clobex®) spray compared to clobetasol propionate 0.05% (Olux®) foam.
详细描述
Same as above.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a clinical diagnosis of moderate to severe plaque psoriasis, defined as 3%-20% of the body surface area involved
排除标准
- •Subjects who have surface area involvement too large that would require more than 50 grams per week of Clobex® spray or more than 50 grams per week of Olux® foam
- •Subjects whose psoriasis involves the scalp, face or groin
- •Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis
研究组 & 干预措施
1
Active Comparator
clobetasol propionate (Clobex®) spray
干预措施: Clobetasol Propionate 0.05% Spray (Drug)
2
Active Comparator
clobetasol propionate (Olux®) foam
干预措施: Clobetasol Propionate 0.05% Foam (Drug)
结局指标
主要结局
Efficacy - Body Surface Area, Investigator Global Severity
时间窗: 6 weeks
次要结局
- Safety - Tolerability assessments, adverse events(6 weeks)
研究者
研究点 (2)
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