Additional Relevant Details  Study DesignThe Phase 3 program consists of two multi-center studies that are each planned to enroll approximately 450 patients with moderate-to-severe acne, first into a 12-week double-blind, vehicle-controlled phase to be followed by 9 months of open-label treatment with the active 4% foam. Both studies will be conducted at multiple sites throughout the United States. Patients will be treated once daily for 12 weeks in the initial double-blind portions of the studies. The primary endpoints are 1) the proportion of patients achieving success at week 12 based on an Investigator’s Global Assessment (success is defined as a score of “clear” or “almost clear” and at least a 2 category improvement from baseline), and 2) the mean change from baseline in inflammatory lesion counts in each treatment group at week 12. Safety evaluation will include reported adverse events, assessments of tolerability, clinical laboratory tests and vital signs. Patients who complete the 12 weeks of treatment will have the option to continue in a long-term open-label safety extension to evaluate the safety of intermittent use of FMX101 for up to an additional 9 months.