Open-label Extension Study Evaluating Long-term Safety and Efficacy of FMX103 1.5% Minocycline Topical Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea

摘要

BACKGROUND: Efficacy and safety of FMX103 1.5% for papulopustular rosacea were previously demonstrated in two 12-week, Phase 3 studies. OBJECTIVE: We sought to evaluate the safety and efficacy of FMX103 1.5% foam for up to 52 weeks of treatment. METHODS: Following the completion of two 12-week, double-blind, vehicle-controlled, Phase 3 studies, subjects were invited to enter a 40-week open-label extension study in which all subjects applied FMX103 1.5% once daily. Efficacy endpoints were the reduction in inflammatory lesions and the rate of IGA treatment success from the double-blind baseline. Safety assessments included adverse events, vital signs, laboratory tests, and facial tolerability signs and symptoms. RESULTS: The favorable safety profile of FMX103 1.5% observed in the double-blind studies was maintained over extended treatment lasting up to one year. There were no serious treatment-related adverse events. Long-term treatment with FMX103 1.5% was associated with a greater than 82-percent reduction in inflammatory lesions from baseline and with over 79 percent of subjects achieving treatment success. At the end of the open-label treatment period, over 82 percent of subjects indicated they were overall “satisfied” or “very satisfied” with FMX103 1.5%. All facial local tolerability symptoms improved through Week 52. LIMITATIONS: Due to the nature of the open-label study, lacking a vehicle-treated control, no statistical comparisons can be made. CONCLUSION: FMX103 1.5% demonstrated a favorable safety and tolerability profile for up to 52 weeks. Long-term efficacy was demonstrated by progressive reductions in inflammatory lesions and increasing IGA treatment success, suggesting that FMX103 1.5% may be a suitable option for the treatment for papulopustular rosacea.