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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorFondazione ISIDE

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Opt-out exercised.

Medical records with insufficient data.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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.

Treatment groups

20,000 Participants
are divided into 5 treatment groups
Group A: Psoriasis Cohort2 interventions
Group B: Atopic Dermatitis Cohort2 interventions
Group C: Alopecia Areata Cohort2 interventions
Group D: Vitiligo Cohort2 interventions
Group E: Hidradenitis Suppurativa Cohort2 interventions

Trial outcomes

Primary outcomes

1

Patient Distribution by Disease Type

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

Time frame
January 2016 to December 2025
2

Age at Treatment Initiation

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

Time frame
January 2016 to December 2025
3

Sex Distribution

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

Time frame
January 2016 to December 2025

Secondary outcomes

1

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.

Time frame
January 2016 to December 2025
2

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.

Time frame
January 2016 to December 2025
3

Treatment Persistence and Drug Survival

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

Time frame
January 2016 to December 2025

Other outcomes

Sponsors and contacts

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