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

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Hand Eczema

Treatments

Genetic: comprhensive spatial transcriptomic profile on lesional skin biopsies

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Adult patients affected by chronic hand eczema
Other group
Description:
Patients with a diagnosis of chronic hand eczema
Treatment:
Genetic: comprhensive spatial transcriptomic profile on lesional skin biopsies

Trial contacts and locations

1

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Central trial contact

Niccolò Gori, MD; Ketty Peris, Prof

Data sourced from clinicaltrials.gov

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