NCT00747032撤回3 期
Multi-Center, Double-Blind, Randomized, Vehicle-controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Reduction in plaque elevation score
研究概览
简要总结
The aim of this trial is to assess the efficacy of NYC-0462 Ointment in the Treatment of Plaque Psoriasis.Treatment medication will be administered as follows: A thin layer of study product will be applied to the affected skin, excluding the face, once daily, at approximately the same time daily.
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 (Participant, Investigator)
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
- •Diagnosis of stable, symptomatic plaque psoriasis
- •Good health with the exception of psoriasis
- •% BSA and plaque elevation requirements
排除标准
- •Subjects who are pregnant, nursing or planning a pregnancy within the study participation period.
- •Subjects who have any systemic or dermatological disorders with the exception of psoriasis
研究组 & 干预措施
1
Active Comparator
NYC 0462 Ointment
干预措施: NYC 0462 Ointment (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in plaque elevation score
时间窗: 8 weeks
次要结局
- Reduction in Investigator´s Global Evaluation, erythema and scaling scores(8 weeks)
研究者
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