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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07336641
Acronym
LANDSCAPE
Enrollment
20000
Registered
2026-01-13
Start date
2026-01-31
Completion date
2028-01-31
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata, Atopic Dermatitis, Hidradenitis Suppurativa, Psoriasis, Vitiligo

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

DRUGConventional 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.

DRUGBiologic 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.

Sponsors

Fondazione ISIDE
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Patient Distribution by Disease TypeJanuary 2016 to December 2025Number and proportion of patients in each disease cohort (psoriasis, atopic dermatitis, alopecia areata, vitiligo, hidradenitis suppurativa).
Age at Treatment InitiationJanuary 2016 to December 2025Mean age (years) at first systemic treatment initiation, reported by disease cohort.
Sex DistributionJanuary 2016 to December 2025Proportion of male and female patients (percentage) by disease cohort.

Secondary

MeasureTime frameDescription
Treatment Patterns and Therapeutic SequencesJanuary 2016 to December 2025Description of systemic treatment utilization patterns, including conventional and biologic therapies, lines of therapy, treatment switches, and reasons for discontinuation.
Disease Severity Assessment Over TimeJanuary 2016 to December 2025Evaluation 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 SurvivalJanuary 2016 to December 2025Analysis of treatment duration and persistence rates for systemic therapies in real-world clinical practice

Countries

Italy

Contacts

Primary ContactDario Gattuso
ricerca@fondazioneiside.org3792225577
Backup ContactAlessandra Narcisi
info@fondazioneiside.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026