Evolution of Chronic Inflammatory Skin Diseases
ConditionInflammatory Skin Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
patients affected with inflammatory skin conditions including atopic dermatitis, prurigo nodularis, Hidradenitis suppurativa, psoriasis
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
advanced sistemic therapies
Drugevaluate the safety and efficacy of advanced sistemic therapies used in inflammatory skin diseases.
Treatment groups
No treatment groups listed
Trial outcomes
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov