The Immunological Profile of Nickel Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- mRNA Nanostring screening
研究概览
简要总结
A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously exposed skin area.
详细描述
Clinically controlled study comprising 15 people with known nickel allergy and 15 healthy persons as control group. At the Department of Allergy and Dermatology, Gentofte Hospital, test participants will be exposed to nickel sulfate in a patch test on their back, which will create an eczema reaction in people with nickel allergy and induce skin resident T-cells. The resident T-cells will enhance further exposure. The eczema is healed over 3-4 weeks, after which the same areas are again exposed to nickel sulfate at different concentrations in a patch test. Skin biopsies of the exposed areas are taken and the immune phenotype is analyzed trough Nanostring RNA technologies of around 600 immunerelated genes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be able to understand the written and oral participant information in Danish.
- •Previously proven nick allergy by patch testing within the last 5 years, for the nickel allergic test participants.
排除标准
- •Pregnancy and / or breastfeeding.
- •Systemic immunomodulatory treatments within the last 14 days.
- •Local treatments of selected skin areas, such as applying hormone cream within the last two weeks or applying cream / lotion within 24 hours up to sample collection.
- •Allergy to local anesthesia.
- •Exposed to solar or sunlight on the back within 21 days.
- •History of inflammatory skin diseases, asthma, Diabetes Mellitus, hives or arthritis (exclusion criteria only for participation in the healthy control group).
- •Participation in another scientific experiment within the last 4 weeks. risks,
结局指标
主要结局
mRNA Nanostring screening
时间窗: 1 month
Screening of 600 immune-related genes
次要结局
- Protein verification(2 month)