Evolution of Chronic Inflammatory Skin Diseases

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.

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Key information

Conditions

Inflammatory Skin Disease Dermatitis Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, 00168, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

advanced sistemic therapies

Drug

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

Primary outcomes

To describe changes over time in the clinical characteristics of the most common chronic inflammatory skin diseases (AD, PSO, HS, CHE, and PN).

Time frame: 120 months

Change 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 course

Time frame: 120 months

identification 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ketty Peris

CONTACT

[email protected]

+390630155701

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: EPICA

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2036
First posted: Jul 16, 2026
Registry last updated: Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed