Evolution of Chronic Inflammatory Skin Diseases

NCT07708896 | Not Yet Recruiting

• 1 other identifier: 27085
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

monocentric retrospective-prospective observational study evaluating the clinical evolution of common chronic inflammatory skin diseases, including atopic dermatitis, psoriasis, prurigo nodularis, chronic hand eczema, and hidradenitis suppurativa. The study will collect demographic, clinical, therapeutic, and validated clinimetric data from patients aged ≥12 years. Its primary aim is to describe changes in disease severity over time. Secondary objectives include identifying demographic, clinical, and treatment-related predictors of moderate-to-severe disease and unfavorable outcomes. Data will cover a 7-year retrospective period and a 10-year prospective follow-up.

Conditions

Inflammatory Skin Disease

Outcome Measures

Primary Outcomes (2)

• To describe changes over time in the clinical characteristics of the most common chronic inflammatory skin diseases (AD, PSO, HS, CHE, and PN).

  Change in disease-specific clinimetric scores used in routine outpatient clinical practice: Eczema Area and Severity Index (EASI); Psoriasis Area and Severity Index (PASI); Hand Eczema Severity Index (HECSI); Investigator's Global Assessment (IGA); Hurley stage; Numerical Rating Scale (NRS) for itch and sleep disturbance; Dermatology Life Quality Index (DLQI); Patient-Oriented Eczema Measure (POEM); and SCORing Atopic Dermatitis (SCORAD).

  120 months

• To identify potential predictors of an unfavorable or favourable disease course

  identification of demographic, clinical, and treatment-related factors associated with moderate-to-severe disease, as defined according to validated cutoffs for the corresponding clinimetric scores (EASI, PASI, HECSI, Hurley, DLQI, POEM, and SCORAD).

  120 months

Interventions

advanced sistemic therapies DRUG

evaluate the safety and efficacy of advanced sistemic therapies used in inflammatory skin diseases.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients affected with inflammatory skin conditions including atopic dermatitis, prurigo nodularis, Hidradenitis suppurativa, psoriasis

You may qualify if:

• Age ≥12 years.
• Patients with a confirmed clinical diagnosis of atopic dermatitis (AD), prurigo nodularis (PN), psoriasis (PSO), chronic hand eczema (CHE), or hidradenitis suppurativa (HS) attending the dermatology outpatient clinics of Fondazione Policlinico Universitario A. Gemelli IRCCS.
• Availability of clinical data at baseline and at subsequent follow-up visits performed according to routine clinical practice.

You may not qualify if:

• Age \<12 years; absence of the minimum required data (treatment start date and at least one follow-up visit with a clinical score).
• Refusal or inability to understand and sign the informed consent form.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ketty Peris

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ketty Peris

CONTACT

+390630155701; ketty.peris@policlinicogemelli.it

Study Design

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

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2036
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)