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Not yet recruitingNCT07336641LANDSCAPEUpdated Jan 15, 2026

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

An observational study in Psoriasis, Atopic Dermatitis and Vitiligo, sponsored by Fondazione ISIDE. Not yet recruiting at 1 site in Italy. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by Fondazione ISIDE · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
20,000
Ages
12 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 104 studies in Psoriasis with a site in Italy — 14 open to participants now, 20 under way, 9 of them phase 3. Psoriasis · Italy.

Planned enrollment
Largest of 24
20,000 · median 192
Started
2026
with 3 others
Observational
24 of 104
5 open now
Primary completion
2026-05
later than 5 of 19 live
Registered
102nd of 104
by date

Among the 104 studies in Psoriasis with a site in Italy, this one has the largest planned enrollment of the 24 observational ones that give a count, is one of 4 that started in 2026, is one of 24 observational ones, reaches primary completion later than 5 of the 19 other live ones, and was the 102nd registered.

Psoriasis

2,030 studies on the registry are indexed under Psoriasis; 277 are open to participants now.

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Open to participants now

14 of the 104 studies in Psoriasis with a site in Italy are open now. Recruiting first, the newest first:

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All 14 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 174 Psoriasis studies recruiting now, 91 (52%) set no upper age limit and 67 (39%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.

This study: 12 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

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.

03

Conditions studied

  • Psoriasis
  • Atopic Dermatitis
  • Vitiligo
  • Alopecia Areata
  • Hidradenitis Suppurativa

Keywords

  • Registry
  • Real-World Evidence
  • Treatment Patterns
  • Dermatology
  • Italy
04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Opt-out exercised.
  2. Medical records with insufficient data.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
20,000 participants (estimated)

Groups and cohorts

  • 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 · 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.

    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.

    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.

    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

    Drug: Conventional Systemic Therapies · Drug: Biologic Therapies

Interventions

  • DrugConventional 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.

  • DrugBiologic 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.

06

What researchers measure

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2026; primary completion for May 2026, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2025
First posted
Jan 13, 2026
StartEst.
Jan 2026
Primary completionEst.
May 2026
CompletionEst.
Jan 2028
Last update
Jan 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07336641
Lead sponsor
Fondazione ISIDE
Responsible party
Sponsor
First posted
Jan 13, 2026
Start date
Jan 2026 (estimated)
Primary completion
May 2026 (estimated)
Completion
Jan 2028 (estimated)
Last update
Jan 15, 2026

Study contacts

Dario Gattuso
Contact
ricerca@fondazioneiside.org
3792225577
Alessandra Narcisi
Contact
info@fondazioneiside.org

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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