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Not yet recruiting NCT07336641

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

— Observational Psoriasis Atopic Dermatitis Vitiligo Alopecia Areata

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conventional Systemic Therapies, Biologic Therapies.
Who it may be relevant to
Registry conditions: Psoriasis, Atopic Dermatitis, Vitiligo, Alopecia Areata. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • 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.

Primary outcome measures

  • Patient Distribution by Disease Type [Time frame: January 2016 to December 2025]
  • Age at Treatment Initiation [Time frame: January 2016 to December 2025]
  • Sex Distribution [Time frame: January 2016 to December 2025]
Secondary outcome measures (3)
  • Treatment Patterns and Therapeutic Sequences [Time frame: January 2016 to December 2025]
  • Disease Severity Assessment Over Time [Time frame: January 2016 to December 2025]
  • Treatment Persistence and Drug Survival [Time frame: January 2016 to December 2025]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Istituto Clinico Humanitas - Dermatology Unit — Rozzano

Identifiers

NCT: NCT07336641 · ISIDE-LANDSCAPE-2025-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗