跳至主要内容
临床试验/NCT06884163
NCT06884163招募中不适用

Characterization of the Immune Signature of Chronic Hand Eczema With an Innovative Approach Combining Spatial Transcriptomics and Single Cell Spatial Proteomics

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
spatial proteomics analysis

研究概览

简要总结

The study explores the immune landscape of chronic hand eczema using spatial transcriptomics and single-cell proteomics, offering new insights into disease mechanisms and potential therapeutic targets.

详细描述

Patients aged 18 to 65 affected with chronic hand eczema will be included in the study. As clinical practice, severity of chronic hand eczema will be evaluated by validated scores as HECSI, DLQI, and NRS itch. Moreover patch tests will be performed. Skin biopsies will also be performed to confirm the diagnosis.

This study utilizes spatial transcriptomics and single-cell spatial proteomics to analyze biopsies of chronic hand eczema. It aims to identify distinct inflammatory cell subgroups and molecular markers that define the immune landscape of chronic hand eczema.

By comparing endogenous (atopic dermatitis, dyshidrotic eczema, idiopathic forms) and exogenous (allergic/irritant) chronic hand eczema, the research wants to describe specific immune endotypes and potential therapeutic targets.

The study also includes idiopathic chronic hand eczema subtypes, such as pompholyx and hyperkeratotic eczema, to clarify immune profiling and improve treatment strategies. By identifying molecular signatures unique to each chronic hand eczema subtype, this research could lead to more personalized and effective therapies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

comphrensive spatial transcriptomic on skin biopsies of chronic hand eczema aims to describe differerent immune endotypes

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
否

入选标准

  • •Patients affected with chronic hand eczema of endogenous and/or exogenous origin, age from 18 to 65 years
  • •Patients affected with eczema located on the hands for at least 3 months or with ≥ 2 disease flare-ups in the last year.
  • •Patients affected with atopic dermatitis affecting the hands and other areas of the body, provided the eczema lesions involve less than 30% of the body surface area.

排除标准

  • •Concurrent or previous treatment with immunosuppressants, except for short courses of systemic corticosteroids (less than one month of continuous treatment), or biologic agents that may affect the clinical aspects or progression of chronic hand eczema.
  • •Patients who have received systemic corticosteroids within one month prior to enrollment in the study.
  • •Patients using topical corticosteroids or calcineurin inhibitors within one week of study enrollment (this time frame is considered to provide a good balance between potential residual pharmacological effects and ethical considerations).
  • •Patients with chronic hand eczema of mixed etiology (e.g., allergic and atopic) or those considered "etiologically unclassifiable" will not be included in the data analysis.

研究组 & 干预措施

Adult patients affected by chronic hand eczema

Other

Patients with a diagnosis of chronic hand eczema

干预措施: comprhensive spatial transcriptomic profile on lesional skin biopsies (Genetic)

结局指标

主要结局

spatial proteomics analysis

时间窗: through study completion, an average of 2 years

Based on the gene expression profile obtained from the spatial transcriptomics analysis (Visium 10X Genomics), a subset of markers of interest will be selected. These markers will then be analyzed using spatial proteomics on the same lesional sections of chronic hand eczema

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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