Journal of drugs in dermatology : JDD · 2014
Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Stein Linda, Kircik Leon, Fowler Joseph, Tan Jerry, Draelos Zoe, Fleischer Alan, Appell Melanie, Steinhoff Martin, Lynde Charles, Liu Hong, Jacovella Jean
Аннотация
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<.001), respectively. Ivermectin 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 week 12, IVM 1% was statistically significantly superior (P<.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.
CONCLUSION: Ivermectin 1% cream was effective and safe in treating inflammatory lesions of papulopustular rosacea.
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<.001), respectively. Ivermectin 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 week 12, IVM 1% was statistically significantly superior (P<.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.
CONCLUSION: Ivermectin 1% cream was effective and safe in treating inflammatory lesions of papulopustular rosacea.