ClinicalTrials.gg
RecruitingNCT07708896EPICAUpdated Sep 25, 2026

Evolution of Chronic Inflammatory Skin Diseases

An observational study in Inflammatory Skin Disease, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Updated Sep 25, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
5,000
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Inflammatory Skin Disease

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03

In context

Dermatitis

238 studies on the registry are indexed under Dermatitis; 34 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 183 across 35 observational studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 25, 2026. See what changed

Ages eligible
12 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

patients affected with inflammatory skin conditions including atopic dermatitis, prurigo nodularis, Hidradenitis suppurativa, psoriasis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 form.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
5,000 participants (estimated)
Patient registry
No

Interventions

  • Drugadvanced sistemic therapies

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

06

What researchers measure

Primary outcomes

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

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

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

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

    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.

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

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

    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.

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

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

    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.

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

  10. Change Over Time in Hurley Stage

    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.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Sep 25, 2026
Sites
Fondazione Policlinico Agostino Gemelli IRCCS is now Recruiting
Sep 25, 2026
Eligibility
1 exclusion criterion removed
What changed in the criteria
Exclusion criteria
  • Removed-
Sep 25, 2026
Primary outcomes
10 added, 2 removed
What changed in the outcomes
  • AddedChange Over Time in Eczema Area and Severity Index (EASI)Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
  • AddedChange Over Time in SCORing Atopic Dermatitis (SCORAD)Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
  • AddedChange Over Time in Patient-Oriented Eczema Measure (POEM)Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
  • AddedChange Over Time in Psoriasis Area and Severity Index (PASI)Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
  • AddedChange Over Time in Hand Eczema Severity Index (HECSI)Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
  • AddedChange Over Time in Investigator's Global Assessment for Prurigo NodularisTime frame: Baseline and every 16 ± 4 weeks, up to 120 months
  • AddedChange Over Time in Itch Numerical Rating Scale (NRS)Time frame: baseline and every 16 ± 4 weeks, up to 120 months
  • AddedChange Over Time in Sleep Numerical Rating Scale (NRS)Time frame: baseline and every 16 ± 4 weeks, up to 120 months
  • AddedChange Over Time in Dermatology Life Quality Index (DLQI)Time frame: baseline and every 16 ± 4 weeks, up to 120 months
  • AddedChange Over Time in Hurley StageTime frame: baseline and every 16 ± 4 weeks, up to 120 months
  • RemovedTo 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
  • RemovedTo identify potential predictors of an unfavorable or favourable disease courseTime frame: 120 months
Sep 25, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Fondazione Policlinico Agostino Gemelli IRCCS · Rome, ItalyContact added (no phone or email listed)
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Not yet recruiting→Recruiting
    Fondazione Policlinico Agostino Gemelli IRCCS is now Recruiting
    Eligibility 1 exclusion criterion removed
    What changed in the criteria
    Exclusion criteria
    • Removed-
    Primary outcomes 10 added, 2 removed
    What changed in the outcomes
    • AddedChange Over Time in Eczema Area and Severity Index (EASI)Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
    • AddedChange Over Time in SCORing Atopic Dermatitis (SCORAD)Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
    • AddedChange Over Time in Patient-Oriented Eczema Measure (POEM)Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
    • AddedChange Over Time in Psoriasis Area and Severity Index (PASI)Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
    • AddedChange Over Time in Hand Eczema Severity Index (HECSI)Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
    • AddedChange Over Time in Investigator's Global Assessment for Prurigo NodularisTime frame: Baseline and every 16 ± 4 weeks, up to 120 months
    • AddedChange Over Time in Itch Numerical Rating Scale (NRS)Time frame: baseline and every 16 ± 4 weeks, up to 120 months
    • AddedChange Over Time in Sleep Numerical Rating Scale (NRS)Time frame: baseline and every 16 ± 4 weeks, up to 120 months
    • AddedChange Over Time in Dermatology Life Quality Index (DLQI)Time frame: baseline and every 16 ± 4 weeks, up to 120 months
    • AddedChange Over Time in Hurley StageTime frame: baseline and every 16 ± 4 weeks, up to 120 months
    • RemovedTo 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
    • RemovedTo identify potential predictors of an unfavorable or favourable disease courseTime frame: 120 months
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Fondazione Policlinico Agostino Gemelli IRCCS · Rome, ItalyContact added (no phone or email listed)
    + 1 other change: date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07708896
Responsible party
Sponsor
First posted
Jul 16, 2026
Start date
Jul 1, 2026
Primary completion
Jul 2030 (estimated)
Completion
Jul 2036 (estimated)
Last update
Sep 25, 2026

Study contacts

Ketty Peris
Contact
ketty.peris@policlinicogemelli.it
+390630155701
Ketty Peris
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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