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临床试验/NCT00311454
NCT00311454Unknown4 期

An Open Single Centre Evaluation of the Reactivity of the T.R.U.E. Test Quaternium-15 Patch and a Real Use Exposure in Subjects Known to Be Allergic to Quaternium-15

Mekos Laboratories AS2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2006年4月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
入组人数
10
试验地点
2

研究概览

简要总结

The study is required by the FDA as part of a post-marketing commitment. The purpose of the study is to compare the reactivity of the TRUE Test quaternium-15 patch and a real use exposure.The subjects will wear the patch test for 48 hours and reading will be performed day 3 or 4. The use test will be applied from day 3 or 4 and untill reaction appears. Reactions from respectively TRUE Test and use test will be compared using the McNemar Change Test.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sensitivity to quaternium-15
  • Age more than 18 years

排除标准

  • Topical or systemic treatment with corticosteroids or immunosuppresives.
  • Treatment with UV-light
  • Widespread active dermatitis or dermatitis on test area

研究者

申办方类型
Industry

研究点 (2)

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