A Randomized, Placebo-Controlled, Parallel-Design, Exploratory Study to Evaluate the Efficacy of fremanezumab in Subjects with Rosacea

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Clinical trial
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Clinical trials

• Clinical trial phase:
  Human pharmacology (Phase I)
• Clinical trial randomisation:
  Randomised clinical trial

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FREMANEZUMAB
• Medical condition to be studied:
  Rosacea

Population studied

• Short description of the study population:
  The study included males and non-pregnant females aged 18 years or older with moderate or severe rosacea.
• 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:
  Other
• Special population of interest, other:
  Patients with rosacea
• Estimated number of subjects:
  40

Study design details

• Main study objective:
  To compare efficacy of active medication over placebo
• Outcomes:
  Proportion of patients considered a treatment success in each group (test and placebo), Number of patients with adverse events in each group
• Data analysis plan:
  Descriptive statistics (n, mean, standard deviation, standard error of mean, median, minimum, and maximum) will be provided for actual values