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
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Fondazione ISIDE
- Enrollment
- 20,000
- Locations
- 1
- Primary Endpoint
- Patient Distribution by Disease Type
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •No opt-out exercised.
Exclusion Criteria
- •Opt-out exercised.
- •Medical records with insufficient data.
Arms & Interventions
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.
Intervention: Conventional Systemic Therapies (Drug)
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.
Intervention: Biologic Therapies (Drug)
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.
Intervention: Conventional Systemic Therapies (Drug)
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.
Intervention: Biologic Therapies (Drug)
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.
Intervention: Conventional Systemic Therapies (Drug)
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.
Intervention: Biologic Therapies (Drug)
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.
Intervention: Conventional Systemic Therapies (Drug)
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.
Intervention: Biologic Therapies (Drug)
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
Intervention: Conventional Systemic Therapies (Drug)
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
Intervention: Biologic Therapies (Drug)
Outcomes
Primary Outcomes
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).
Age at Treatment Initiation
Time Frame: January 2016 to December 2025
Mean age (years) at first systemic treatment initiation, reported by disease cohort.
Sex Distribution
Time Frame: January 2016 to December 2025
Proportion of male and female patients (percentage) by disease cohort.
Secondary Outcomes
- Treatment Patterns and Therapeutic Sequences(January 2016 to December 2025)
- Treatment Persistence and Drug Survival(January 2016 to December 2025)
- Disease Severity Assessment Over Time(January 2016 to December 2025)