NCT00565279已完成3 期
Efficacy and Safety of ASF 1057 Cream 0.5% in the Treatment of Seborrhoeic Dermatitis: A Phase III Randomised, Double-Blind, Vehicle and Placebo Controlled, Parallel Groups, Multi-Centre Trial.
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
- 300
- 主要终点
- Proportion of responders, defined as patients with OSS ≤ 1 score units.
研究概览
简要总结
A growing body of evidence supports the hypothesis that the pathophysiology of seborrhoeic dermatitis has a potentially causative neurogenic inflammatory aspect. ASF1057 is a new drug that acts through a modulation of neurogenic inflammation through important complementary mechanisms of action. This study will test the efficacy and safety of ASF1057 in the treatment of patients with seborrhoeic 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of moderate to severe seborrhoeic dermatitis
排除标准
- •Other active skin diseases
- •Use of certain systemic and topical treatments
- •Extensive sun exposure
研究组 & 干预措施
ASF1057
Experimental
干预措施: ASF1057 (Drug)
ASF1057 placebo
Placebo Comparator
干预措施: ASF1057 (Drug)
ASF1057 Vehicle
Placebo Comparator
干预措施: ASF1057 (Drug)
结局指标
主要结局
Proportion of responders, defined as patients with OSS ≤ 1 score units.
时间窗: Baseline, day 7, day 14, and day 21
次要结局
未报告次要终点
研究者
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