A Taieb, JP Ortonne, T Ruzicka, J Roszkiewicz, J Berth-Jones, MH Peirone, J Jacovella
Superiority of Ivermectin 1% Cream Over Metronidazole 0.75% Cream in Treating Inflammatory Lesions of Rosacea: A Randomized, Investigator-Blinded Trial
Br J Dermatol 2014 Sep 16;[EPub Ahead of Print]
Few therapeutic alternatives currently exist in the treatment of papulopustular rosacea (PPR).
Demonstrate superiority of once-daily ivermectin 1% cream (IVM 1%) vs. twice-daily metronidazole 0.75% cream regarding percent reduction of inflammatory lesions in subjects with moderate to severe PPR.
In this Phase 3, investigator-blinded, randomized, parallel group study, subjects received IVM 1% once daily, or metronidazole 0.75% twice daily over 16 weeks. Efficacy assessments were inflammatory lesion counts and Investigator's Global Assessment (IGA). Safety assessments included incidence of adverse events (AEs) and local tolerance parameters. Subjects evaluated their disease following a 5-grade scale and completed questionnaires.
A total of 962 subjects were randomized to receive IVM 1% (n=478) or metronidazole 0.75% (n=484). At week 16, IVM 1% was significantly superior to metronidazole 0.75% in terms of reduction from baseline in inflammatory lesions (83.0% vs. 73.7%; p<.001), observed as early as week 3 (last observation carried forward - LOCF). IGA results (subjects "clear" or "almost clear") also favoured IVM 1%: 84.9% vs. 75.4%, respectively (p<.001). Incidence of AEs was comparable between groups and local tolerability was better for IVM 1%. More subjects receiving ivermectin rated their global improvement as "excellent" or "good."
Ivermectin 1% cream was significantly superior to metronidazole 0.75% cream and achieved high patient satisfaction.