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NCT Number: NCT07336641

LANDSCAPE: Demographics and Treatment Patterns of Patients With Immune-Mediated Inflammatory Skin Diseases 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented diagnosis of psoriasis, atopic dermatitis, vitiligo, alopecia areata, or hidradenitis suppurativa.
  • Age 12 years or older at the first recorded visit.
  • Eligible for or treated with systemic therapies.
  • At least one documented visit during January 2016 to December 2025.
  • No opt-out exercised.

Exclusion criteria

  • Opt-out exercised.
  • Medical records with insufficient data.

Treatment and study plan

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.

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.

Primary outcomes

  1. Patient Distribution by Disease Type

    Time frame: January 2016 to December 2025

    Number and proportion of patients in each disease cohort (psoriasis, atopic dermatitis, alopecia areata, vitiligo, hidradenitis suppurativa).

  2. Age at Treatment Initiation

    Time frame: January 2016 to December 2025

    Mean age (years) at first systemic treatment initiation, reported by disease cohort.

  3. Sex Distribution

    Time frame: January 2016 to December 2025

    Proportion of male and female patients (percentage) by disease cohort.

Secondary outcomes

  1. Treatment Patterns and Therapeutic Sequences

    Time frame: 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.

  2. Disease Severity Assessment Over Time

    Time frame: 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.

  3. Treatment Persistence and Drug Survival

    Time frame: January 2016 to December 2025

    Analysis of treatment duration and persistence rates for systemic therapies in real-world clinical practice

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandra Narcisi

CONTACT

[email protected]

Dario Gattuso

CONTACT

[email protected]

3792225577

Sponsors and collaborators

Lead sponsor

Fondazione ISIDE

Other

Registry information

Official study title

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

Acronym: LANDSCAPE

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jan 13, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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