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NCT Number: NCT07708896

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

Location status: Recruiting

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

  1. Change Over Time in Eczema Area and Severity Index (EASI)

    Time frame: Baseline and every 16 ± 4 weeks, up to 120 months

    Change over time in Eczema Area and Severity Index (EASI) in participants with atopic dermatitis. EASI ranges from 0 to 72, with higher scores indicating greater disease severity.

  2. Change Over Time in SCORing Atopic Dermatitis (SCORAD)

    Time frame: Baseline and every 16 ± 4 weeks, up to 120 months

    Change over time in SCORing Atopic Dermatitis (SCORAD) in participants with atopic dermatitis. SCORAD ranges from 0 to 103, with higher scores indicating greater disease severity.

  3. Change Over Time in Patient-Oriented Eczema Measure (POEM)

    Time frame: Baseline and every 16 ± 4 weeks, up to 120 months

    Change over time in Patient-Oriented Eczema Measure (POEM) in participants with atopic dermatitis. POEM ranges from 0 to 28, with higher scores indicating greater patient-reported disease severity.

  4. Change Over Time in Psoriasis Area and Severity Index (PASI)

    Time frame: Baseline and every 16 ± 4 weeks, up to 120 months

    Change over time in Psoriasis Area and Severity Index (PASI) in participants with psoriasis. PASI ranges from 0 to 72, with higher scores indicating greater disease severity.

  5. Change Over Time in Hand Eczema Severity Index (HECSI)

    Time frame: Baseline and every 16 ± 4 weeks, up to 120 months

    Change over time in Hand Eczema Severity Index (HECSI) in participants with chronic hand eczema. HECSI ranges from 0 to 360, with higher scores indicating greater disease severity.

  6. Change Over Time in Investigator's Global Assessment for Prurigo Nodularis

    Time frame: Baseline and every 16 ± 4 weeks, up to 120 months

    Change in Investigator Global Assessment (IGA) in patients with prurigo nodularis

  7. Change Over Time in Itch Numerical Rating Scale (NRS)

    Time frame: baseline and every 16 ± 4 weeks, up to 120 months

    Change over time in itch intensity assessed using the Numerical Rating Scale (NRS). Scores range from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch. Higher scores indicate worse itch.

  8. Change Over Time in Sleep Numerical Rating Scale (NRS)

    Time frame: baseline and every 16 ± 4 weeks, up to 120 months

    Change over time in sleep disturbance assessed using the Numerical Rating Scale (NRS). Scores range from 0 to 10, with higher scores indicating greater sleep disturbance.

  9. Change Over Time in Dermatology Life Quality Index (DLQI)

    Time frame: baseline and every 16 ± 4 weeks, up to 120 months

    Change over time in Dermatology Life Quality Index (DLQI). Scores range from 0 to 30, with higher scores indicating greater impairment in dermatology-related quality of life.

  10. Change Over Time in Hurley Stage

    Time frame: baseline and every 16 ± 4 weeks, up to 120 months

    Change over time in hidradenitis suppurativa severity according to Hurley staging. Hurley stage ranges from Stage I to Stage III, with higher stages indicating more severe disease.

Interested in participating?

Recruiting

Interested in participating?

Request Info

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
Sep 25, 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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