Evolution of Chronic Inflammatory Skin Diseases

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Change Over Time in Eczema Area and Severity Index (EASI) — Baseline and every 16 ± 4 weeks, up to 120 months
  Change over time in Eczema Area and Severity Index (EASI) in participants with atopic dermatitis. EASI ranges from 0 to 72, with higher scores indicating greater disease severity.
• Change Over Time in SCORing Atopic Dermatitis (SCORAD) — Baseline and every 16 ± 4 weeks, up to 120 months
  Change over time in SCORing Atopic Dermatitis (SCORAD) in participants with atopic dermatitis. SCORAD ranges from 0 to 103, with higher scores indicating greater disease severity.
• Change Over Time in Patient-Oriented Eczema Measure (POEM) — Baseline and every 16 ± 4 weeks, up to 120 months
  Change over time in Patient-Oriented Eczema Measure (POEM) in participants with atopic dermatitis. POEM ranges from 0 to 28, with higher scores indicating greater patient-reported disease severity.
• Change Over Time in Psoriasis Area and Severity Index (PASI) — Baseline and every 16 ± 4 weeks, up to 120 months
  Change over time in Psoriasis Area and Severity Index (PASI) in participants with psoriasis. PASI ranges from 0 to 72, with higher scores indicating greater disease severity.
• Change Over Time in Hand Eczema Severity Index (HECSI) — Baseline and every 16 ± 4 weeks, up to 120 months
  Change over time in Hand Eczema Severity Index (HECSI) in participants with chronic hand eczema. HECSI ranges from 0 to 360, with higher scores indicating greater disease severity.
• Change Over Time in Investigator's Global Assessment for Prurigo Nodularis — Baseline and every 16 ± 4 weeks, up to 120 months
  Change in Investigator Global Assessment (IGA) in patients with prurigo nodularis
• Change Over Time in Itch Numerical Rating Scale (NRS) — baseline and every 16 ± 4 weeks, up to 120 months
  Change over time in itch intensity assessed using the Numerical Rating Scale (NRS). Scores range from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch. Higher scores indicate worse itch.
• Change Over Time in Sleep Numerical Rating Scale (NRS) — baseline and every 16 ± 4 weeks, up to 120 months
  Change over time in sleep disturbance assessed using the Numerical Rating Scale (NRS). Scores range from 0 to 10, with higher scores indicating greater sleep disturbance.
• Change Over Time in Dermatology Life Quality Index (DLQI) — baseline and every 16 ± 4 weeks, up to 120 months
  Change over time in Dermatology Life Quality Index (DLQI). Scores range from 0 to 30, with higher scores indicating greater impairment in dermatology-related quality of life.
• Change Over Time in Hurley Stage — baseline and every 16 ± 4 weeks, up to 120 months
  Change over time in hidradenitis suppurativa severity according to Hurley staging. Hurley stage ranges from Stage I to Stage III, with higher stages indicating more severe disease.

Trial sites (1)

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy