Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: Results of two randomized, double-blind, vehicle-controlled pivotal studies

BACKGROUND: Treatments for papulopustular rosacea (PPR) are limited. OBJECTIVE: To demonstrate the efficacy and safety of once-daily ivermectin 1% cream in subjects with moderate to severe PPR. METHODS: Two identically designed, randomized, double-blind, controlled studies of ivermectin 1% cream (IVM 1%) or vehicle once daily for 12 weeks were conducted in subjects with moderate to severe PPR. Efficacy assessments were Investigator's Global Assessment (IGA) of disease severity and inflammatory lesion counts. Safety assessments included incidence of adverse events (AEs) and local tolerance parameters. Subjects evaluated their rosacea and completed satisfaction and quality of life (QoL) questionnaires. RESULTS: In both studies, a greater proportion of subjects in the IVM 1% group achieved treatment success (IGA "clear" or "almost clear"): 38.4% and 40.1% vs 11.6% and 18.8% for vehicle (both P CONCLUSION: Ivermectin 1% cream was effective and safe in treating inflammatory lesions of papulopustular rosacea.