NCT02929745已完成不适用
Elucidating the Fundamental Differences Between HLA-Cw6 Positive and HLA-Cw6 Negative Psoriasis Skin Lesions, With a Comparison to Healthy Skin, at the Single Cell Level of the Infiltrated Immune Cell Types
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Determination of immune cell population from skin biopsies
研究概览
简要总结
The purpose of this study is to understand how genetics play a role in psoriasis. Specifically, a genetic allele HLA-Cw6 is known to be associated with psoriasis, and this study aims to find out how it affects genetic and protein expression in patients with psoriasis, compared to healthy people, at a single-cell level using a novel flow cytometry and RNA-sequencing protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •For subjects in the psoriasis group:
- •Ability to provide written consent and comply with the protocol
- •At least 18 years of age
- •Diagnosis of plaque psoriasis for at least 6 months prior to enrollment
- •BSA > 5% and at least one target plaque on trunk or extremities greater than 10cm2
- •For control subjects:
- •Ability to provide written consent and comply with the protocol
- •At least 18 years of age
- •No previous diagnosis of psoriasis or other inflammatory skin conditions
排除标准
- •For subjects in the psoriasis group:
- •Subject has non-plaque form of psoriasis.
- •Subject has drug-induced psoriasis.
- •Pregnancy at any point during the study period.
- •Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.
- •Known HIV positive status.
- •Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
- •Known coagulopathy.
- •For control subjects:
- •Any physical examination findings by the investigators consistent with psoriasis or other inflammatory skin conditions.
- •Pregnancy at any point during the study period.
- •Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.
- •Known HIV positive status.
- •Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
- •Known coagulopathy.
- •Use of any immunosuppressant or immunomodulating therapies within 6 months.
结局指标
主要结局
Determination of immune cell population from skin biopsies
时间窗: once
次要结局
- Determination of HLA -cw6 status from blood samples(once)
- Determination of diferentially expressed genes from skin biopsies(once)
研究者
研究点 (2)
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