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Evolution of Chronic Inflammatory Skin Diseases

Evolution of Chronic Inflammatory Skin Diseases

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07708896
Acronym
EPICA
Enrollment
5000
Registered
2026-07-16
Start date
2026-07-01
Completion date
2036-07-01
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Skin Disease

Brief summary

monocentric retrospective-prospective observational study evaluating the clinical evolution of common chronic inflammatory skin diseases, including atopic dermatitis, psoriasis, prurigo nodularis, chronic hand eczema, and hidradenitis suppurativa. The study will collect demographic, clinical, therapeutic, and validated clinimetric data from patients aged ≥12 years. Its primary aim is to describe changes in disease severity over time. Secondary objectives include identifying demographic, clinical, and treatment-related predictors of moderate-to-severe disease and unfavorable outcomes. Data will cover a 7-year retrospective period and a 10-year prospective follow-up.

Interventions

DRUGadvanced sistemic therapies

evaluate the safety and efficacy of advanced sistemic therapies used in inflammatory skin diseases.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum

Inclusion criteria

Age ≥12 years. Patients with a confirmed clinical diagnosis of atopic dermatitis (AD), prurigo nodularis (PN), psoriasis (PSO), chronic hand eczema (CHE), or hidradenitis suppurativa (HS) attending the dermatology outpatient clinics of Fondazione Policlinico Universitario A. Gemelli IRCCS. Availability of clinical data at baseline and at subsequent follow-up visits performed according to routine clinical practice.

Exclusion criteria

Age \<12 years; absence of the minimum required data (treatment start date and at least one follow-up visit with a clinical score). Refusal or inability to understand and sign the informed consent form. \-

Design outcomes

Primary

MeasureTime frameDescription
To describe changes over time in the clinical characteristics of the most common chronic inflammatory skin diseases (AD, PSO, HS, CHE, and PN).120 monthsChange in disease-specific clinimetric scores used in routine outpatient clinical practice: Eczema Area and Severity Index (EASI); Psoriasis Area and Severity Index (PASI); Hand Eczema Severity Index (HECSI); Investigator's Global Assessment (IGA); Hurley stage; Numerical Rating Scale (NRS) for itch and sleep disturbance; Dermatology Life Quality Index (DLQI); Patient-Oriented Eczema Measure (POEM); and SCORing Atopic Dermatitis (SCORAD).
To identify potential predictors of an unfavorable or favourable disease course120 monthsidentification of demographic, clinical, and treatment-related factors associated with moderate-to-severe disease, as defined according to validated cutoffs for the corresponding clinimetric scores (EASI, PASI, HECSI, Hurley, DLQI, POEM, and SCORAD).

Countries

Italy

Contacts

CONTACTKetty Peris
ketty.peris@policlinicogemelli.it+390630155701
PRINCIPAL_INVESTIGATORKetty Peris

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026