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Not yet recruiting NCT07708896

Evolution of Chronic Inflammatory Skin Diseases

Observational Inflammatory Skin Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: advanced sistemic therapies.
Who it may be relevant to
Registry conditions: Inflammatory Skin Disease. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • 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]
  • To identify potential predictors of an unfavorable or favourable disease course [Time frame: 120 months]

Eligibility criteria

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.

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione Policlinico Agostino Gemelli IRCCS — Rome

Identifiers

NCT: NCT07708896 · 27085

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗