NCT02235480已完成2 期
A Phase II Trial to Evaluate the Anti-psoriatic Efficacy and Tolerability of Tazarotene in a Gel Formulation in Patients With Mild to Moderate Nail Psoriasis - Parallel Group Comparison
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- % reduction in the Nail Psoriasis Severity Index ( NAPSI )
研究概览
简要总结
The aim of this study is to determine the efficacy and safety of topical application of the gel compared to placebo in nail psoriasis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Key inclusion criteria:
- •Mild to moderate nail psoriasis on at least one fingernail
排除标准
- •Key exclusion criteria:
- •any other skin condition, with a potential to affect the nails or to interfere with evaluation of the disease;
- •history of hypersensitivity to retinoids or to other components of the trial medication
- •topical treatment of nails with antipsoriatics in the 4 weeks preceding the treatment phase;
- •systemic treatment of psoriasis within the three months before the treatment phase of the trial or during the trial
- •intralesional steroid injection before the treatment phase of the trial
- •phototherapy before the treatment phase of the trial;
- •any chronic infection or condition capable of interfering with the conduct of the trial;
- •evidence of drug or alcohol abuse;
- •symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks preceding the treatment phase of the trial;
- •participation in another clinical trial within the last 4 weeks prior to first treatment in this clinical trial;
- •pregnancy or nursing;
研究组 & 干预措施
Tazarotene Gel
Experimental
once daily
干预措施: Experimental Tazarotene Gel (Drug)
Placebo Gel
Placebo Comparator
once daily
干预措施: Placebo (Drug)
结局指标
主要结局
% reduction in the Nail Psoriasis Severity Index ( NAPSI )
时间窗: Day85
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Day 85)
研究者
研究点 (4)
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