Status:
RECRUITING
Immune Signature of Chronic Hand Eczema Unveiled by Spatial Transcriptomics and Single-Cell Proteomics
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborating Sponsors:
LEO Pharma
Conditions:
Hand Eczema
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06884163
Start Date
January 13 2025
End Date
January 1 2027
Last Update
March 19 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168