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NCT Number: NCT06884163

Immune Signature of Chronic Hand Eczema Unveiled by Spatial Transcriptomics and Single-Cell Proteomics

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location status: Recruiting

Location contact

ketty peris, professor

CONTACT

[email protected]

0630155284

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

comprhensive spatial transcriptomic profile on lesional skin biopsies

Genetic

Spatial transcriptomics (Visium, 10X Genomics) will be used to analyze gene expression of chronic eczema derived from lesional skin biopsies

Primary outcomes

  1. spatial proteomics analysis

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ketty Peris, Prof

CONTACT

[email protected]

+390630155284

Niccolò Gori, MD

CONTACT

[email protected]

+390630155284

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • LEO Pharma

Registry information

Official study title

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

Acronym: ECMANDO

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 19, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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