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

LANDSCAPE - Demographic Characteristics and Treatment Profiles of Patients Affected by Inflammatory Skin Diseases (Psoriasis, Atopic Dermatitis, Alopecia Areata, Vitiligo, Hidradenitis Suppurativa) in Italian Clinical Practice

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis; Atopic Dermatitis; Vitiligo; Hidradenitis Suppurativa; Alopecia Areata
• Intervention / Treatment: Drug: Conventional Systemic Therapies; Drug: Biologic Therapies

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.

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Dario Gattuso; Phone Number: 3792225577; Email: ricerca@fondazioneiside.org
• Study Contact Backup: Name: Alessandra Narcisi; Email: info@fondazioneiside.org

Study Locations

• Italy
  • Lombardy
    • Rozzano, Lombardy, Italy, 20089
      • IRCCS Istituto Clinico Humanitas - Dermatology Unit
      • Contact: Antonio Costanzo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: 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.; 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.
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.	Drug: 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.; 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.
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.	Drug: 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.; 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.
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.	Drug: 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.; 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.
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	Drug: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fondazione ISIDE

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Estimated): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Registry; Dermatology; Italy; Treatment Patterns; Real-World Evidence
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Infections; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Papulosquamous; Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hypopigmentation; Pigmentation Disorders; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Hidradenitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Alopecia Areata; Hidradenitis Suppurativa; Vitiligo; Psoriasis; Dermatitis, Atopic; Therapeutics; Biological Therapy
• Other Study ID Numbers: ISIDE-LANDSCAPE-2025-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No