Evolution of Chronic Inflammatory Skin Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 5,000
- Locations
- 1
- Primary Endpoint
- To describe changes over time in the clinical characteristics of the most common chronic inflammatory skin diseases (AD, PSO, HS, CHE, and PN).
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To describe changes over time in the clinical characteristics of the most common chronic inflammatory skin diseases (AD, PSO, HS, CHE, and PN).
Time Frame: 120 months
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).
To identify potential predictors of an unfavorable or favourable disease course
Time Frame: 120 months
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).
Secondary Outcomes
No secondary outcomes reported