P. Foley, A. Taieb, T. Ruzicka, M.H. Peirone, J. Jacovella
Background: Several therapeutic options are available in papulopustular rosacea. Metronidazole 0.75% cream (MTZ 0.75%) is one of the most frequently prescribed. Well- designed and adequately powered studies comparing new treatments to MTZ 0.75% are required.
Objective: Demonstrate superiority of ivermectin 1% cream (IVM 1%) compared to MTZ 0.75% in moderate to severe papulopustular rosacea.
Methods: Phase 3, investigator-blinded, randomized study. Subjects applied IVM 1% once daily or MTZ 0.75% twice daily over 16 weeks. Efﬁcacy assessments were inﬂamma- tory lesion counts and Investigator’s Global Assessment (IGA) (5-grade scale). Subject’s global improvement of rosacea was assessed using a 5-grade self-evaluation ques- tionnaire at week 16. Safety was also assessed.
Results: 962 subjects were randomized (IVM 1% group = 478 and MTZ 0.75% group = 484). At week 16, IVM 1% was signiﬁcantly superior to MTZ 0.75% in terms of per- cent reduction from baseline in inﬂammatory lesion counts (83.0% vs. 73.7%; p < 0.001), observed as early as week 3 (LOCF) and continuing through week 16. Success rate deﬁned as an IGA of 0 (subjects “clear”) or IGA of 1 (subjects “almost clear”) conﬁrmed superiority of IVM 1%: 84.9% vs. 75.4%, respectively (p < 0.001). More subjects applying IVM 1% rated their global improvement as “excellent” or “good,” compared to MTZ 0.75% (85.5% vs. 74.8%). Incidence of adverse events was comparable between groups (32.4% vs. 33.1% of subjects in the IVM 1% and MTZ 0.75% groups, respectively), and local tolerability was better for IVM 1%. Conclusions: IVM 1% was signiﬁcantly superior to MTZ 0.75% and achieved high subject satisfaction.
A non-interventional-prospective-12-month study to characterise REAL-life effectiveness and treatmentpatterns of secukinumab, and current standard-of-care of chronic plaque psoriasis in Asia-Pacific & MiddleEast