What is this study trying to find out about chronic hand eczema?

This study is exploring the immune characteristics of chronic hand eczema to better understand disease mechanisms and identify potential treatment targets. Researchers are using advanced genetic and protein analysis methods on skin biopsies to reveal detailed immune profiles. This work aims to improve personalized therapies for people living with this condition.

Who may be eligible for this chronic hand eczema clinical trial?

Adults aged 18 to 65 with chronic hand eczema lasting at least 3 months or with multiple flare-ups may be eligible. Both endogenous and exogenous eczema types are included, with some specific exclusions like recent use of certain medications. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic hand eczema clinical trial?

Study-related care, including the biopsy procedures and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 65Years

All Genders

ID06884163

Characterization of the Immune Signature of Chronic Hand Eczema Using Spatial Transcriptomics and Single Cell Spatial Proteomics

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-19

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the immune characteristics of chronic hand eczema in adults aged 18 to 65 years. This study aims to reveal new insights into the disease by comparing different types of chronic hand eczema, including endogenous forms like atopic dermatitis and idiopathic subtypes such as pompholyx and hyperkeratotic eczema, as well as exogenous forms such as allergic and irritant eczema. The goal is to identify immune cell groups and molecular markers that could lead to personalized treatments. The study uses advanced techniques called spatial transcriptomics and single-cell spatial proteomics to analyze skin biopsy samples from affected areas. Patients diagnosed with chronic hand eczema will have their disease severity assessed through validated scores and patch tests, followed by skin biopsies to confirm the diagnosis. These biopsies will undergo detailed genetic and protein analysis to map the immune landscape of the eczema. Participants will be involved for an average of two years during which the main measurement will be the spatial proteomics analysis of their skin samples. Throughout the study, severity scores like HECSI, DLQI, and itch scales will be used to evaluate the condition. The research team will monitor the immune profiles to understand disease mechanisms and potential targets for therapy, with no masking or blinding involved.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

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

You will not qualify if you...

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
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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 1 day

Participants undergo skin biopsies and patch tests to confirm diagnosis and evaluate severity of chronic hand eczema.

1 visit (in-person)

Long-term Monitoring

Duration - Through study completion, an average of 2 years

Participants are monitored through spatial proteomics analysis of biopsy samples to study immune signatures of chronic hand eczema.

Trial Site Locations

Total: 1 location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy, 00168

Actively Recruiting

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Research Team

Ketty Peris, Prof

Niccolò Gori, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

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Published Research Related To This Trial

Patch testing of budesonide in Italy: The SIDAPA baseline series experience, 2018-2019.

Luca Stingeni, Rossella Marietti, Leonardo Bianchi...

https://pubmed.ncbi.nlm.nih.gov/33931866

The transcriptome of hand eczema assessed by tape stripping.

Julie B K Sølberg, Anna S Quaade, Stine B Jacobsen...

https://pubmed.ncbi.nlm.nih.gov/34812515

Innovation in the treatment of atopic dermatitis: Emerging topical and oral Janus kinase inhibitors.

Chisa Nakashima, Shigeto Yanagihara, Atsushi Otsuka

https://pubmed.ncbi.nlm.nih.gov/34815171

Guidelines for diagnosis, prevention and treatment of hand eczema--short version.

Thomas L Diepgen, Klaus E Andersen, Oliver Chosidow...

https://pubmed.ncbi.nlm.nih.gov/25640512

Guidelines for diagnosis, prevention, and treatment of hand eczema.

Jacob P Thyssen, Marie L A Schuttelaar, Jose H Alfonso...

https://pubmed.ncbi.nlm.nih.gov/34971008

Prevalence, incidence, and severity of hand eczema in the general population - A systematic review and meta-analysis.

Anna S Quaade, Anne B Simonsen, Anne-Sofie Halling...

https://pubmed.ncbi.nlm.nih.gov/33548072