Exploring the immune profile of chronic hand eczema
Characterization of the Immune Signature of Chronic Hand Eczema With an Innovative Approach Combining Spatial Transcriptomics and Single Cell Spatial Proteomics
This study is trying to understand the immune system's response in adults with chronic hand eczema to help create better, personalized treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06884163 on ClinicalTrials.gov |
What this trial studies
This study investigates the immune landscape of chronic hand eczema through advanced techniques like spatial transcriptomics and single-cell proteomics. It includes patients aged 18 to 65 with chronic hand eczema, assessing disease severity using validated scores and conducting skin biopsies for diagnosis confirmation. The research aims to identify distinct inflammatory cell subgroups and molecular markers that characterize the immune response in various subtypes of chronic hand eczema, potentially leading to more personalized treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with chronic hand eczema lasting at least 3 months or experiencing multiple flare-ups in the past year.
Not a fit: Patients currently using immunosuppressants or systemic corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to more effective and tailored therapies for patients suffering from chronic hand eczema.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding immune responses in other dermatological conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Ketty Peris, Prof — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Ketty Peris, Prof
- Email: ketty.peris@policlinicogemelli.it
- Phone: +390630155284
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.