NCT07336641

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Jan 2028

First Submitted

Initial submission to the registry

December 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

December 30, 2025

Last Update Submit

January 13, 2026

Conditions

Keywords

RegistryReal-World EvidenceTreatment PatternsDermatologyItaly

Outcome Measures

Primary Outcomes (3)

  • Patient Distribution by Disease Type

    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

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

    January 2016 to December 2025

  • Sex Distribution

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

    January 2016 to December 2025

Secondary Outcomes (3)

  • Treatment Patterns and Therapeutic Sequences

    January 2016 to December 2025

  • Disease Severity Assessment Over Time

    January 2016 to December 2025

  • Treatment Persistence and Drug Survival

    January 2016 to December 2025

Study Arms (5)

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 TherapiesDrug: 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 TherapiesDrug: 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 TherapiesDrug: 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 TherapiesDrug: 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 TherapiesDrug: Biologic Therapies

Interventions

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.

Alopecia Areata CohortAtopic Dermatitis CohortHidradenitis Suppurativa CohortPsoriasis CohortVitiligo Cohort

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 CohortAtopic Dermatitis CohortHidradenitis Suppurativa CohortPsoriasis CohortVitiligo Cohort

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Opt-out exercised.
  • Medical records with insufficient data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Clinico Humanitas - Dermatology Unit

Rozzano, Lombardy, 20089, Italy

Location

MeSH Terms

Conditions

PsoriasisDermatitis, AtopicVitiligoAlopecia AreataHidradenitis Suppurativa

Interventions

Biological Therapy

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHypopigmentationPigmentation DisordersAlopeciaHypotrichosisHair DiseasesSkin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationHidradenitisSweat Gland Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Alessandra Narcisi

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 13, 2026

Study Start

January 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations