NCT01053247已完成3 期
Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0416 Ointment.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 793
- 试验地点
- 1
- 主要终点
- Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment
研究概览
简要总结
The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis.
Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 2 weeks.
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
- 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
- •Clinical diagnosis of Atopic Dermatitis
- •Good health with the exception of Atopic Dermatitis
- •Percent Body Surface Area minimum 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 Atopic Dermatitis
研究组 & 干预措施
Test
Experimental
Test product that contains the active pharmaceutical ingredient
干预措施: 0416 (Drug)
Reference
Active Comparator
Reference product that contains active pharmaceutical ingredient
干预措施: tacrolimus ointment 0.1% (Drug)
Vehicle
Placebo Comparator
Placebo that contains no active pharmaceutical ingredient
干预措施: Vehicle of 0416 test product (Drug)
结局指标
主要结局
Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment
时间窗: 2 weeks
次要结局
- The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA).(2 weeks)
研究者
研究点 (1)
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