About this trial
This multicenter retrospective observational registry study will collect existing clinical data from Italian centers to describe epidemiology, treatment patterns, clinical evolution, safety, and comorbidities in patients aged 12 years and older with psoriasis, atopic dermatitis, vitiligo, alopecia areata, or hidradenitis suppurativa.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented diagnosis of psoriasis, atopic dermatitis, vitiligo, alopecia areata, or hidradenitis suppurativa.
Age 12 years or older at the first recorded visit.
Eligible for or treated with systemic therapies.
At least one documented visit during January 2016 to December 2025.
Disqualifiers
Opt-out exercised.
Medical records with insufficient data.
Trial population
Patients with inflammatory skin diseases (psoriasis, atopic dermatitis, alopecia areata, vitiligo, hidradenitis suppurativa) followed at approximately 25 dermatology centers across Italy. The study population reflects real-world clinical practice, including patients managed in both academic and community dermatology settings within the Italian National Health Service (Servizio Sanitario Nazionale). Data are extracted retrospectively from routine medical records.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Conventional Systemic Therapies
DrugRetrospective observation of conventional systemic treatments prescribed in routine clinical practice, including but not limited to methotrexate, cyclosporine, acitretin, and other conventional agents. No drugs are administered as part of this study; treatment data are collected from existing medical records.
Biologic Therapies
DrugRetrospective observation of biologic treatments prescribed in routine clinical practice, including but not limited to TNF-α inhibitors, IL-17 inhibitors, IL-23 inhibitors, IL-4/IL-13 inhibitors, and JAK inhibitors. No drugs are administered as part of this study; treatment data are collected from existing medical records.
Treatment groups
Trial outcomes
Primary outcomes
Patient Distribution by Disease Type
Number and proportion of patients in each disease cohort (psoriasis, atopic dermatitis, alopecia areata, vitiligo, hidradenitis suppurativa).
Age at Treatment Initiation
Mean age (years) at first systemic treatment initiation, reported by disease cohort.
Sex Distribution
Proportion of male and female patients (percentage) by disease cohort.
Secondary outcomes
Treatment Patterns and Therapeutic Sequences
Description of systemic treatment utilization patterns, including conventional and biologic therapies, lines of therapy, treatment switches, and reasons for discontinuation.
Disease Severity Assessment Over Time
Evaluation of disease severity measures as recorded in routine clinical practice, including PASI for psoriasis, EASI/IGA for atopic dermatitis, SALT for alopecia areata, and Hurley staging for hidradenitis suppurativa.
Treatment Persistence and Drug Survival
Analysis of treatment duration and persistence rates for systemic therapies in real-world clinical practice
Sponsors and contacts
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