Clinical trial NCT06884163: Immune Signature of Chronic Hand Eczema Unveiled by Spatial Transcriptomics and Single-Cell Proteomics
Official title: Characterization of the Immune Signature of Chronic Hand Eczema With an Innovative Approach Combining Spatial Transcriptomics and Single Cell Spatial Proteomics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Eczema
Keywords: atopic
biopsy
itch
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: LEO Pharma
First posted: 2025-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: spatial proteomics analysis
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Ketty Peris, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.