Post marketing surveillance to evaluate Soolantra cream 1% for the treatment of inflammatory lesions of rosacea in adult patients

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Soolantra cream 1% (Ivermectin)
• Medical condition to be studied:
  Papulopustular rosacea

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:
  600

Study design details

• Main study objective:
  This Post Marketing Surveillance (PMS) aims to evaluate the safety and efficacy of Soolantra cream 1% in adult patients in practical usage condition.(1) Serious adverse events adverse drug reactions(2) Serious or non-serious unlisted, unexpected adverse events or adverse drug reactions(3) Listed serious or non-serious adverse drug reactions (4) Other safety, efficacy related information
• Outcomes:
  The number of occurrence case, occurrence rate and frequency of AE, SAE, ADR, SADR, unexpected AE, unexpected SAE, unexpected ADR and unexpected SADR will be analyzed with Wald or 95% confidence interval, Absolute change and change rate in inflammatory lesion count from baseline at 4 weeks after administrationOverall improvement rate at 4 weeks after administration
• Data analysis plan:
  number of occurrence case, occurrence rate and frequency of AE, SAE, ADR, SADR, unexpected AE, unexpected SAE, unexpected ADR and unexpected SADR will be analyzed with Wald or 95% confidence interval