NCT00437255已完成4 期
An Evaluation of the Efficacy, Safety, Preference and Duration of Response of Clobex® (Clobetasol Propionate) Spray and Taclonex® (Calcipotriene 0.05%/Betamethasone Dipropionate 0.064%) Ointment in Subjects With 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
- 122
- 试验地点
- 4
- 主要终点
- Overall Disease Severity
研究概览
简要总结
Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.
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
- •Moderate to severe psoriasis involving 3-20% of the body surface area
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 100 grams per week of Taclonex® Ointment
- •Subjects having psoriasis that involves the scalp, face, or groin
研究组 & 干预措施
1
Active Comparator
Clobex® Spray
干预措施: Clobetasol Propionate, 0.05% (Drug)
2
Active Comparator
Taclonex® Ointment
干预措施: Calcipotriene and betamethasone dipropionate ointment (Drug)
结局指标
主要结局
Overall Disease Severity
时间窗: End of treatment (Week 4)
Tolerability assessments, incidence of adverse events
时间窗: Baseline, Weeks 1, 2, 4 and 8
次要结局
- Overall Disease Severity(Weeks 1, 2 and 8)
- Investigator Global Assessment(End of treatment (week 4) and Weeks 1, 2 and 8)
研究者
研究点 (4)
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