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Taieb A.,Service de Dermatologie et Dermatologie Pediatrique | Ortonne J.P.,Service de dermatologie | Ruzicka T.,Ludwig Maximilians University of Munich | Roszkiewicz J.,Medical University of Gdansk | And 3 more authors.
British Journal of Dermatology | Year: 2015

Background Few therapeutic alternatives currently exist in the treatment of papulopustular rosacea (PPR). Objectives To demonstrate superiority of once-daily ivermectin 1% cream (IVM 1%) once daily vs. twice-daily metronidazole (MTZ 0·75%) cream, regarding percentage reduction of inflammatory lesions in subjects with moderate to severe PPR. Methods In this Phase 3, investigator-blinded, randomized, parallel-group study, subjects received IVM 1% once daily, or MTZ 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. Results A total of 962 subjects were randomized to receive IVM 1% (n = 478) or MTZ 0·75% (n = 484). At week 16, IVM 1% was significantly superior to MTZ 0·75% in terms of reduction from baseline in inflammatory lesions (83·0% vs. 73·7%; P < 0.001), 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 < 0.001). Incidence of AEs was comparable between groups and local tolerability was better for IVM 1%. More subjects receiving IVM rated their global improvement as 'excellent' or 'good.' Conclusions Ivermectin 1% cream was significantly superior to MTZ 0·75% cream and achieved high patient satisfaction. What's already known about this topic? Few therapeutic alternatives currently exist in treating papulopustular rosacea (PPR). What does this study add? Ivermectin 1% cream (IVM 1%) once daily was significantly superior to metronidazole 0·75% cream (MTZ 0.75%) twice-daily, in reducing inflammatory lesion counts, as early as week 3 and through 4 months of treatment. IVM 1% cream can be considered an effective anti-inflammatory treatment for PPR. © 2014 British Association of Dermatologists. Source


Taieb A.,Service de Dermatologie et Dermatologie Pediatrique | Khemis A.,University of Nice Sophia Antipolis | Ruzicka T.,Ludwig Maximilians University of Munich | Baranska-Rybak W.,Medical University of Gdansk | And 5 more authors.
Journal of the European Academy of Dermatology and Venereology | Year: 2016

Background There are a limited number of approved treatments for papulopustular rosacea (PPR) and remission is difficult to maintain after successful treatment. Objectives To investigate remission over a 36-week extension period in patients with moderate to severe PPR successfully treated with 16 weeks' treatment with ivermectin 1% cream once daily (QD) or metronidazole 0.75% cream twice daily (BID) in a randomized, parallel-group Phase III study. Methods Treatment was discontinued in patients initially successfully treated [Investigator's Global Assessment (IGA) score of 0 or 1] with ivermectin 1% cream QD (n = 399) or metronidazole 0.75% cream BID (n = 365; Part A) and patients were followed every 4 weeks for up to 36 weeks (Part B). Treatment with the same study treatment as used in Part A was only re-initiated if patients relapsed (IGA ≥ 2). Efficacy assessments were: time to first relapse; relapse rate; and number of days free of treatment. Safety assessments included incidence of adverse events and local cutaneous signs and symptoms. Results The median time to first relapse was significantly longer (115 days vs. 85 days) and relapse rates at the end of the study period significantly lower (62.7% vs. 68.4%) for patients initially successfully treated with ivermectin 1% compared with metronidazole 0.75%; Kaplan-Meier plot demonstrated a statistically significant difference between the two arms (P = 0.0365). The median number of days free of treatment was higher for ivermectin compared with metronidazole (196 days vs. 169.5 days; P = 0.026). The percentage of patients who experienced a related adverse event was equally low in both groups. Conclusion The results of this relapse study showed that an initial successful treatment with ivermectin 1% cream QD significantly extended remission of rosacea compared with initial treatment with metronidazole 0.75% cream BID following treatment cessation. © 2015 European Academy of Dermatology and Venereology. Source

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