NCT01465282已完成2 期
A Randomized, Placebo-controlled, Phase IIb Study to Evaluate the Efficacy, Safety and Tolerability of 0.05%, 0.1% and 0.5% w/w Topical CT327 When Applied Twice Daily in Subjects With Psoriasis Vulgaris
Creabilis SA0 个研究点目标入组 160 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 主要终点
- Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of 3 dose strengths of CT327 ointment (0.05%, 0.1% and 0.05% w/w) compared to a placebo, when applied twice daily for up to 8 weeks, to the psoriatic plaques of patients with psoriasis vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged at least 18 years.
- •Stable psoriasis vulgaris
排除标准
- •Subjects with guttate, erythrodermic, exfoliative or pustular psoriasis.
研究组 & 干预措施
0.05% (w/w) CT327 ointment
Experimental
0.05% (w/w) CT327 ointment applied BID for up to 8 weeks.
干预措施: CT327 0.05% (Drug)
0.1% (w/w) CT327 ointment
Experimental
0.1% (w/w) CT327 ointment applied BID for up to 8 weeks.
干预措施: CT327 0.1% (Drug)
0.5% (w/w) CT327 ointment
Experimental
0.5% (w/w) CT327 ointment applied BID for up to 8 weeks.
干预措施: CT327 0.5% (Drug)
Placebo ointment
Placebo Comparator
Placebo ointment
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment.
时间窗: Week 8
次要结局
- Local and systemic toleration(8 weeks)
研究者
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