Alopecia Areata, Atopic Dermatitis, Hidradenitis Suppurativa, Psoriasis, Vitiligo
Conditions
Keywords
Registry, Real-World Evidence, Treatment Patterns, Dermatology, Italy
Brief summary
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.
Detailed description
LANDSCAPE is a non-interventional, multicenter, retrospective disease registry based on routinely collected clinical data (electronic health records and available medical documentation) from participating Italian centers. Data will cover the period January 2016 to December 2025. The registry will support real-world evaluation of treatment patterns, effectiveness and safety outcomes, disease severity scores, persistence/switching, and associated comorbidities across psoriasis, atopic dermatitis, vitiligo, alopecia areata, and hidradenitis suppurativa. Data will be pseudonymized prior to entry into the EDC system. Patients who exercise the opt-out right will not be included.
Interventions
Retrospective 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.
Retrospective 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.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Documented diagnosis of psoriasis, atopic dermatitis, vitiligo, alopecia areata, or hidradenitis suppurativa. 2. Age 12 years or older at the first recorded visit. 3. Eligible for or treated with systemic therapies. 4. At least one documented visit during January 2016 to December 2025. 5. No opt-out exercised.
Exclusion criteria
1. Opt-out exercised. 2. Medical records with insufficient data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Distribution by Disease Type | January 2016 to December 2025 | Number and proportion of patients in each disease cohort (psoriasis, atopic dermatitis, alopecia areata, vitiligo, hidradenitis suppurativa). |
| Age at Treatment Initiation | January 2016 to December 2025 | Mean age (years) at first systemic treatment initiation, reported by disease cohort. |
| Sex Distribution | January 2016 to December 2025 | Proportion of male and female patients (percentage) by disease cohort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Patterns and Therapeutic Sequences | January 2016 to December 2025 | 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 | January 2016 to December 2025 | 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 | January 2016 to December 2025 | Analysis of treatment duration and persistence rates for systemic therapies in real-world clinical practice |
Countries
Italy