Prospective, observational, non-interventional, multicenter study to investigate treatment outcomes and patient satisfaction of Enstilum® foam (calcipotriol/betamethasone aerosol foam) as topical treatment of adult patients with psoriasis under the routine practice in Korea

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

Population studied

• 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)
• Estimated number of subjects:
  218

Study design details

• Main study objective:
  This study aims to investigate treatment outcomes and patient satisfaction of Enstilum® foam under routine practice conditions. Korean patient profile for selected day-to-day therapies including Enstilum® foam and the therapy(ies) used prior to Enstilum® foam will be investigated through this study.
• Outcomes:
  the proportion and 95% confidence interval of "treatment success" subjects in IGA at week 4, Change of severity of psoriasis, PASI50, PASI75, Change of PASI, Change of symptoms, clinically significant itch relief, satisfaction with Enstilum® foam, Change of DLQI, subjects achieving a DLQI ≤ 5 points, correlation between baseline severity and drug consumption, exploratory endpoints in subgroup analysis by initial plaque size, drug consumption, frequency of treatment
• Data analysis plan:
  Data processing and statistical analysis will be carried out with SAS software version 9.4 or a more recent version. The following populations are evaluated: • The safety analysis will be performed for a subset of the all patients who have submitted a written consent to use their data in this study and who have reported using Enstilum® foam at least once. • The exploratory analysis will be performed for subgroup of the safety evaluation and includes all patients for which additionally primary endpoint variable has been documented at least once. In accordance with the non-interventional nature of NIS, the statistical analysis is descriptive and exploratory. All collected variables are listed and described by graphical representations or frequency or characteristic tables. As far as statistical tests are calculated, they have exploratory character and did not serve the confirmatory test before the examination of formulated hypotheses. An α-adjustment is not made.