PsoriasisLANDSCAPENCT07336641
LANDSCAPE: Demographics and Treatment Patterns of Patients With Immune-Mediated Inflammatory Skin Diseases in Italian Clinical Practice
An observational study of Psoriasis and Atopic Dermatitis, run by Fondazione ISIDE at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Psoriasis, Atopic Dermatitis, Vitiligo
- What is being tested?
- Conventional Systemic Therapies and Biologic Therapies
- How many people
- 20,000 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2026to Jan 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- Opt-out exercised.
- Medical records with insufficient data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alessandra Narcisi contact
Italy1 site
IRCCS Istituto Clinico Humanitas - Dermatology Unit
Rozzano, Lombardy, 20089
Antonio Costanzo, MD
About this study
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
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.
Read the 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.
- Being tested
- Conventional Systemic Therapies, Biologic Therapies
- Keywords
- Registry, Real-World Evidence, Treatment Patterns, Dermatology, Italy
- Medical subject headings
- Psoriasis, Dermatitis, Atopic, Vitiligo, Alopecia Areata, Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Systemic TherapiesDrug
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 TherapiesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Conventional Systemic Therapies; Drug: Biologic Therapies | |
| 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. Receives: Drug: Conventional Systemic Therapies; Drug: Biologic Therapies | |
| 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. Receives: Drug: Conventional Systemic Therapies; Drug: Biologic Therapies | |
| 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. Receives: Drug: Conventional Systemic Therapies; Drug: Biologic Therapies | |
| 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 Receives: Drug: Conventional Systemic Therapies; Drug: Biologic Therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Distribution by Disease Type
Number and proportion of patients in each disease cohort (psoriasis, atopic dermatitis, alopecia areata, vitiligo, hidradenitis suppurativa).
Measured: January 2016 to December 2025
Age at Treatment Initiation
Mean age (years) at first systemic treatment initiation, reported by disease cohort.
Measured: January 2016 to December 2025
Sex Distribution
Proportion of male and female patients (percentage) by disease cohort.
Measured: January 2016 to December 2025
Secondary outcomes (3)
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.
Measured: January 2016 to December 2025
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.
Measured: January 2016 to December 2025
Treatment Persistence and Drug Survival
Analysis of treatment duration and persistence rates for systemic therapies in real-world clinical practice
Measured: January 2016 to December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione ISIDE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336641
- Sponsor's protocol ID
- ISIDE-LANDSCAPE-2025-001
- Acronym
- LANDSCAPE
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared due to data protection requirements under GDPR (EU 2016/679) and Italian privacy legislation. Aggregate anonymized results will be published in peer-reviewed journals and presented at scientific conferences.