A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.

Trial Profile

A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Mar 2015

At a glance

  • Drugs Ivermectin (Primary) ; Azelaic acid
  • Indications Bacterial infections; Rosacea
  • Focus Registrational; Therapeutic Use
  • Sponsors Galderma
  • Most Recent Events

    • 27 Mar 2015 According to a Gladerma media release, ivermectin cream [Soolantra] received a positive outcome by European Decentralised Procedure for Approval. The Marketing Authorization application was based on this and other two phase III trials.
    • 17 Feb 2015 According to Galderma media release, 1% ivermectin cream [Soolantra] has been approved by US FDA. The approval was based on the data from this and another pivotal phase III trial (see 700211490).
    • 04 Apr 2014 The trial enrolled 683 patients, according to ClinicalTrials.gov.
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