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.
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
- 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.