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

NCT ID: NCT06884163

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-13

Study Completion Date

2027-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hand Eczema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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

Study Groups

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Adult patients affected by chronic hand eczema

Patients with a diagnosis of chronic hand eczema

Group Type OTHER

comprhensive spatial transcriptomic profile on lesional skin biopsies

Intervention Type GENETIC

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

Interventions

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comprhensive spatial transcriptomic profile on lesional skin biopsies

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

Intervention Type GENETIC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ketty Peris, Prof

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Ketty Peris, Prof

Role: CONTACT

+390630155284

Niccolò Gori, MD

Role: CONTACT

+390630155284

Facility Contacts

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ketty peris, professor

Role: primary

0630155284

References

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Stingeni L, Marietti R, Bianchi L, Guarneri F, Ferrucci SM, Faraci AG, Foti C, Romita P, Patruno C, Napolitano M, Gallo R, Corazza M, Schena D, Milanesi N, Bruni F, Pigatto P, Musumeci ML, Martina E, Piras V, Tramontana M, Hansel K. Patch testing of budesonide in Italy: The SIDAPA baseline series experience, 2018-2019. Contact Dermatitis. 2021 Sep;85(3):317-323. doi: 10.1111/cod.13873. Epub 2021 May 24.

Reference Type BACKGROUND
PMID: 33931866 (View on PubMed)

Solberg JBK, Quaade AS, Jacobsen SB, Andersen JD, Kampmann ML, Morling N, Litman T, Thyssen JP, Johansen JD. The transcriptome of hand eczema assessed by tape stripping. Contact Dermatitis. 2022 Feb;86(2):71-79. doi: 10.1111/cod.14015. Epub 2021 Dec 8.

Reference Type BACKGROUND
PMID: 34812515 (View on PubMed)

Nakashima C, Yanagihara S, Otsuka A. Innovation in the treatment of atopic dermatitis: Emerging topical and oral Janus kinase inhibitors. Allergol Int. 2022 Jan;71(1):40-46. doi: 10.1016/j.alit.2021.10.004. Epub 2021 Nov 21.

Reference Type BACKGROUND
PMID: 34815171 (View on PubMed)

Diepgen TL, Andersen KE, Chosidow O, Coenraads PJ, Elsner P, English J, Fartasch M, Gimenez-Arnau A, Nixon R, Sasseville D, Agner T. Guidelines for diagnosis, prevention and treatment of hand eczema--short version. J Dtsch Dermatol Ges. 2015 Jan;13(1):77-85. doi: 10.1111/ddg.12510. English, German.

Reference Type BACKGROUND
PMID: 25640512 (View on PubMed)

Thyssen JP, Schuttelaar MLA, Alfonso JH, Andersen KE, Angelova-Fischer I, Arents BWM, Bauer A, Brans R, Cannavo A, Christoffers WA, Crepy MN, Elsner P, Fartasch M, Filon FL, Gimenez-Arnau AM, Goncalo M, Guzman-Perera MG, Hamann CR, Hoetzenecker W, Johansen JD, John SM, Kunkeler ACM, Hadzavdic SL, Molin S, Nixon R, Oosterhaven JAF, Rustemeyer T, Serra-Baldrich E, Shah M, Simon D, Skudlik C, Spiewak R, Valiukeviciene S, Voorberg AN, Weisshaar E, Agner T. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022 May;86(5):357-378. doi: 10.1111/cod.14035. Epub 2022 Mar 3.

Reference Type BACKGROUND
PMID: 34971008 (View on PubMed)

Quaade AS, Simonsen AB, Halling AS, Thyssen JP, Johansen JD. Prevalence, incidence, and severity of hand eczema in the general population - A systematic review and meta-analysis. Contact Dermatitis. 2021 Jun;84(6):361-374. doi: 10.1111/cod.13804. Epub 2021 Feb 23.

Reference Type BACKGROUND
PMID: 33548072 (View on PubMed)

Other Identifiers

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7219

Identifier Type: -

Identifier Source: org_study_id

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