Ivermectin 1% Cream, an effective and safe topical treatment of inflammatory lesions of papulopustular rosacea
Australas J Dermatol
Background: Treatments for papulopustular rosacea (PPR) are limited. The objective was to demonstrate the efficacy and safety of once-daily application of ivermectin 1% cream in subjects with moderate to severe PPR. Methods: Two identical 12-week, randomized, double-blind, parallel group, vehicle controlled studies were conducted with ivermectin 1% cream (IVM 1%) in subjects with moderate to severe PPR. Main efficacy assessments were Investigator's Global Assessment (IGA) of disease severity and inflammatory lesion counts. Safety assessments included incidence of adverse events (AEs)andlocal 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 < 0.001), respectively. IVM 1% was superior to vehicle in terms of reduction from baseline in inflammatory lesion counts (76.0% and 75.0% vs. 50.0% for both vehicle groups, respectively). For all endpoints, starting at week 4 and continuing through the end of the study (week 12), IVM 1% was statistically significantly superior (p < 0.001). Fewer subjects treated by IVM 1% reported dermatologic AEs, and a higher proportion of subjects were observed to have no skin dryness or itching compared to vehicle. Significantly more subjects receiving IVM 1% reported having an “excellent” or “good” improvement, along with an improved QoL. Conclusions: Ivermectin 1% cream was effective and safe in treating inflammatory lesions of papulopustular rosacea.