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

January 13, 2026 updated by: Fondazione ISIDE

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • Lombardy
      • Rozzano, Lombardy, Italy, 20089
        • IRCCS Istituto Clinico Humanitas - Dermatology Unit
        • Contact:
          • Antonio Costanzo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Opt-out exercised.
  2. Medical records with insufficient data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
January 2016 to December 2025
Age at Treatment Initiation
Time Frame: January 2016 to December 2025
Mean age (years) at first systemic treatment initiation, reported by disease cohort.
January 2016 to December 2025
Sex Distribution
Time Frame: January 2016 to December 2025
Proportion of male and female patients (percentage) by disease cohort.
January 2016 to December 2025

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
January 2016 to December 2025
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.
January 2016 to December 2025
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
January 2016 to December 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione ISIDE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ISIDE-LANDSCAPE-2025-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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