Managing PSOriasis in the REAL world: One-year prospective, observational study of the journey of patients with plaque psoriasis prescribed calcipotriol/betamethasone aerosol foam or other topical therapy (PSOREAL)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Enstilar
• Medical condition to be studied:
  Psoriasis

Population studied

• Short description of the study population:
  Adult patients suffering from psoriasis vulgaris and treated with topical therapy.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  1214

Study design details

• Main study objective:
  To describe and compare real-world short-term treatment success with calcipotriol/betamethasone foam and other topical psoriasis treatments. To describe and compare calcipotriol/betamethasone foam and other topical psoriasis treatments regard-ing the long-term real-world success of the initial treatment strategy.
• Outcomes:
  Proportion of patients reporting Patient reported Psoriasis Global Assessment (PaGA) success (defined as clear or almost clear skin at the end of the initial treatment period). EuroQol 5 dimensions/five levels questionnaire EQ-5D-5L Dermatology Life Quality Index DLQI Psoriasis Symptom Inventory PSI Treatment satisfaction
• Data analysis plan:
  Descriptive statistics. Effectiveness endpoints are analysed using crude and adjusted regression models.