A Prospective Study to Investigate the Pathophysiology of the Koebner's Phenomenon in Psoriasis and Lichen Planus
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 70
- 主要终点
- Differences in the transcriptomic profile comparing psoriasis patients with and without induced koebner phenomenon
研究概览
简要总结
Psoriasis and lichen planus often occur at mechanically irritated skin sites (e.g. tight clothing). The investigators would like to investigate this phenomenon in more detail in this study. For this purpose, the skin is specifically irritated at a small and cosmetically favorable site by tearing off scotch tape or rubbing with a wooden spatula. In order to be able to examine the inflammatory processes caused by the irritation more closely, a small skin sample and a skin swab are taken from the irritated area. This skin sample and the swab are repeated after three and fourteen days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dermatologist diagnosed psoriasis (group psoriasis), lichen planus (group lichen planus) or no skin disease (group healthy controls)
- •Subject is capable of giving informed consent
- •Signed informed consent
排除标准
- •Use of systemic immunosuppressive/immunmodulating agents in the last three months
- •Use of topical anti-inflammatory treatment in the last 7 days in the area of sampling.
- •Phototherapy in the last 4 weeks
- •Active or recurrent serious bacterial, fungal or viral infection at the time of enrollment by patient history, including patients with Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection, active or untreated latent tuberculosis.
- •Female patients of childbearing potential who are pregnant or breast feeding or planning a pregnancy during the duration of the trial and/or not practicing acceptable birth control for the duration of the trial
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons.
研究组 & 干预措施
Tape stripping
干预措施: Tape stripping (Procedure)
结局指标
主要结局
Differences in the transcriptomic profile comparing psoriasis patients with and without induced koebner phenomenon
时间窗: Day 0, Day 3 (optional), Day 14 (optional)
Transcriptomic profile at all timepoints (reads per 55µm diameter dot)
次要结局
- Characterization of involved immune cells in the skin comparing psoriasis patients with and without induced koebner phenomenon(Day 0, Day 3 (optional), Day 14 (optional))
- Characterization of skin mikrobiome(Day 0, Day 3, Day 14)
- Differences in the proteomic profile comparing psoriasis patients with and without induced koebner phenomenon(Day 0, Day 3 (optional), Day 14 (optional))
研究者
Marie-Charlotte Brüggen
Prof. Dr. med. PhD
University of Zurich