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
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
- 否
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
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine AdsorbedInfections, BacterialNCT02339155Emergent BioSolutions573
Unknown
4 期
An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. AnthracisInfection, BacterialAnthraxNCT03088111Elusys Therapeutics100
已完成
不适用
Hemoclin Gel for the Treatment of HemorrhoidsHemorrhoids Grade I and IINCT05124379Karo Pharma AB49
进行中(未招募)
不适用
The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY)ObesityNCT05368259Allurion Technologies1,000
已完成
不适用
Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence ProductsUrinary IncontinenceNCT04846270Essity Hygiene and Health AB35
