Clinical Data Trial Design and ResultsThe double-blind, randomized, placebo-controlled Phase 2 trial included 233 subjects with moderate-to-severe rosacea enrolled at 18 sites in Germany. Subjects were randomized to receive either 1 of 2 doses of FMX103 minocycline foam (3% or 1.5%) or vehicle foam once daily over 12 weeks, followed up by a 4-week post-treatment evaluation. The efficacy endpoints were the absolute change in the number of inflammatory lesions – papules and pustules (primary endpoint) and improvement of the Investigator Global Assessment of severity, or IGA (first secondary endpoint). Safety and tolerability were also evaluated.1.      Baseline severityThe mean baseline lesion count for all groups ranged from 30.6 to 34.5 and the IGA scores were all moderate (score 3) or severe (score 4); with about 50-60% of the subjects having a severe rating. 2.      Significant reduction in the number of inflammatory lesionsAt the Week 12 timepoint designated for the primary efficacy analysis, the 1.5% and 3% doses of FMX103 both significantly reduced the number of papules and pustules vs. the vehicle (1.5% and 3%, both p<0.001, ANCOVA, intent-to-treat analysis). The mean reduction in lesion count of each treatment group vs. its baseline was 21.1 for the 1.5% dose, 19.9 for the 3% dose and 7.8 for vehicle; the corresponding percent reductions were 61.4% and 55.5% for the FMX103 1.5% and 3% groups, respectively, and 29.7% for the vehicle. 3.      Significant Improvement in Investigator’s Global Assessment (IGA) scoresBoth the 1.5% and 3% doses of FMX-103 were significantly better compared to vehicle in reducing the IGA score by 2 grades and in reaching a “clear” (score=0) or “almost clear” (score=1) rating at Week 12 (P < 0.01 and P < 0.05, respectively, Cochran–Mantel–Haenszel test). Both the 1.5% and 3% doses were efficacious and there was no statistically significant difference between doses.4.      Safety and tolerabilityFMX103appeared to be generally safe and well-tolerated. There were no serious treatment‑related AEs and few subjects overall reported any treatment-related AEs (2, 4 and 5 in the 1.5%, 3% and vehicle groups, respectively). A total of 4 subjects discontinued the study due to an adverse event (3 in the 3% group and 1 in the vehicle group).