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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psoriasis Cohort | Adult patients (≥18 years) diagnosed with moderate-to-severe psoriasis according to clinical criteria, treated with systemic conventional and/or biologic therapies at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records. |
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| Atopic Dermatitis Cohort | Adult patients (≥18 years) diagnosed with moderate-to-severe atopic dermatitis, treated with systemic conventional and/or biologic therapies at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records. |
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| Alopecia Areata Cohort | Adult patients (≥18 years) diagnosed with alopecia areata, treated with systemic therapies at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records. |
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| Vitiligo Cohort | Adult patients (≥18 years) diagnosed with vitiligo, treated at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Systemic Therapies | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Distribution by Disease Type | Number and proportion of patients in each disease cohort (psoriasis, atopic dermatitis, alopecia areata, vitiligo, hidradenitis suppurativa). | January 2016 to December 2025 |
| Age at Treatment Initiation | Mean age (years) at first systemic treatment initiation, reported by disease cohort. | January 2016 to December 2025 |
| Sex Distribution | Proportion of male and female patients (percentage) by disease cohort. | January 2016 to December 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | January 2016 to December 2025 |
| Disease Severity Assessment Over Time |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dario Gattuso | Contact | 3792225577 | ricerca@fondazioneiside.org | |
| Alessandra Narcisi | Contact | info@fondazioneiside.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Clinico Humanitas - Dermatology Unit | Rozzano | Lombardy | 20089 | Italy |
Individual participant data will not be shared due to data protection requirements under GDPR (EU 2016/679) and Italian privacy legislation. Aggregate anonymized results will be published in peer-reviewed journals and presented at scientific conferences.
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| Hidradenitis Suppurativa Cohort |
Adult patients (≥18 years) diagnosed with hidradenitis suppurativa, treated with systemic conventional and/or biologic therapies at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records |
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| Biologic Therapies | Drug | 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. |
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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. |
| January 2016 to December 2025 |
| Treatment Persistence and Drug Survival | Analysis of treatment duration and persistence rates for systemic therapies in real-world clinical practice | January 2016 to December 2025 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D003876 | Dermatitis, Atopic |
| D014820 | Vitiligo |
| D000506 | Alopecia Areata |
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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