NCT00667056已完成4 期
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Trial to Assess the Safety and Efficacy of 0.1% Tacrolimus Ointment in the Treatment of Chronic Allergic Contact Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 98
- 主要终点
- Success using the Physician's Global Assessment (PGA)
研究概览
简要总结
A study of subjects with a known nickel allergy comparing Tacrolimus to placebo, both associated with nickel patches to determine the safety and efficacy of treating Chronic Allergic Contact Dermatitis with Tacrolimus Ointment
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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a history of allergy to nickel
排除标准
- •Subject is pregnant or lactating
- •Subject fails to react to the nickel disks (grade 0), reacts with a questionable (grade 1) or extreme (grade 4) reaction or the subject's reactions on the left and right arms are not of the same grade of intensity
- •Subject has a known hypersensitivity to any component of the test medications
- •Subject has any other significant dermatological condition that affects >10% of the body surface area or general medical condition that could interfere with the study evaluation
- •Subject has any significant medical condition that could compromise immune responsiveness
研究组 & 干预措施
1
Experimental
干预措施: tacrolimus ointment (Drug)
2
Placebo Comparator
干预措施: placebo ointment (Drug)
结局指标
主要结局
Success using the Physician's Global Assessment (PGA)
时间窗: 8 Weeks
次要结局
- Investigator and subject ACD Sign and Symptoms(8 Weeks)
研究者
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