Immune Signature of Chronic Hand Eczema Unveiled by Spatial Transcriptomics and Single-Cell Proteomics
NCT ID: NCT06884163
Last Updated: 2025-03-19
Study Results
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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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-01-13
2027-01-01
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Adult patients affected by chronic hand eczema
Patients with a diagnosis of chronic hand eczema
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
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.
Other Identifiers
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7219
Identifier Type: -
Identifier Source: org_study_id
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