NCT01703793已完成2 期
A Parallel-group, Vehicle-controlled, Randomized, Double-blind Study of the Efficacy and Safety of Product 49778 and Product 10156 in Subjects With Seborrheic Dermatitis
Medicis Global Service Corporation0 个研究点目标入组 240 人开始时间: 2012年9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
- 240
- 主要终点
- Symptom Improvement (investigator assessment)
研究概览
简要总结
The purpose of this study is to determine if two test products are safe and effective in the treatment of seborrheic dermatitis.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Investigator assessment of seborrheic dermatitis.
- •Additional criteria as identified in the protocol.
排除标准
- •History of or ongoing psoriasis of the scalp.
- •History of or ongoing atopic dermatitis of the scalp.
- •Additional criteria as identified in the protocol.
研究组 & 干预措施
Test Product 10156
Experimental
Product 10156 treatment, twice a week for four weeks.
干预措施: Test Product 10156 (Drug)
Vehicle
Placebo Comparator
Vehicle (placebo) treatment, twice a week for four weeks.
干预措施: Vehicle (placebo) (Drug)
Test Product 49778
Experimental
Product 49778 treatment, twice a week for four weeks.
干预措施: Test Product 49778 (Drug)
结局指标
主要结局
Symptom Improvement (investigator assessment)
时间窗: Week 4
Proportion of subjects with a response of clear or almost clear, and at least a two-grade improvement from baseline to week 4
次要结局
- Symptom Improvement (subject assessment)(Weeks 2 and 4)
研究者
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