CLINICAL TRIAL | the abstract
Principal Investigator: Dr. Jennifer Cather
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.
Acne rosacea affects at least 16 million people in the US. The study compared a 1% ivermectin cream to a placebo vehicle for the first 12 weeks, with a roll-over to a 40-week investigator blinded study. At this time, 1% ivermectin was compared to azelaic acid 15% gel. The study led to the approval of Soolantra® (1% ivermectin) for the treatment of adults with acne rosacea.
SOTA Formula Consideration Based on Data:
Anti-inflammatories help treat rosacea. Current medical treatment options for rosacea, such as topical metronidazole, azelaic acid, and tetracyclines, are thought to work through their anti-inflammatory effects. Learn more about the benefits of patent-pending SOTA Shade Tincture and SOTA Rebound and Reclaim Topicals for inflammation.
Study dates: 2011-2013