LANDSCAPE: Demographics and Treatment Patterns of Patients With Immune-Mediated Inflammatory Skin Diseases in Italian Clinical Practice

NCT ID: NCT07336641

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriasis Atopic Dermatitis Vitiligo Alopecia Areata Hidradenitis Suppurativa

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Conventional Systemic Therapies

Intervention Type 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.

Biologic Therapies

Intervention Type 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.

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.

Conventional Systemic Therapies

Intervention Type 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.

Biologic Therapies

Intervention Type 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.

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.

Conventional Systemic Therapies

Intervention Type 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.

Biologic Therapies

Intervention Type 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.

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.

Conventional Systemic Therapies

Intervention Type 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.

Biologic Therapies

Intervention Type 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.

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

Conventional Systemic Therapies

Intervention Type 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.

Biologic Therapies

Intervention Type 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.

Interventions

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Conventional Systemic Therapies

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.

Intervention Type DRUG

Biologic Therapies

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione ISIDE

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Istituto Clinico Humanitas - Dermatology Unit

Rozzano, Lombardy, Italy

Site Status

Countries

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Italy

Central Contacts

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Dario Gattuso

Role: CONTACT

3792225577

Alessandra Narcisi

Role: CONTACT

Facility Contacts

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Antonio Costanzo, MD

Role: primary

Other Identifiers

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ISIDE-LANDSCAPE-2025-001

Identifier Type: -

Identifier Source: org_study_id

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