A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Clinical Trial to Assess the Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily for 12 Weeks in Subjects With Papulopustular Rosacea

Trial Profile

A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Clinical Trial to Assess the Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily for 12 Weeks in Subjects With Papulopustular Rosacea

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Sep 2016

At a glance

  • Drugs Azelaic acid (Primary)
  • Indications Rosacea
  • Focus Registrational; Therapeutic Use
  • Sponsors Bayer
  • Most Recent Events

    • 31 Jul 2015 According to Foamix media release, the US FDA has approved azalaic acid (Finacea) foam, 15% for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.
    • 24 Jul 2014 Primary endpoint (Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment) has been met, according to Bayer HealthCare media release.
    • 24 Jul 2014 Primary endpoint (Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)) has been met, according to Bayer HealthCare media release.
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