Topical Retapamulin Ointment, 1%, versus Sodium Fusidate Ointment, 2%, for Impetigo: A Randomized, Observer-Blinded, Noninferiority StudyOranje A.P.a · Chosidow O.b · Sacchidanand S.c · Todd G.d · Singh K.e · Scangarella N.e · Shawar R.e · Twynholm M.f
aDepartment of Dermatology and Venereology (Pediatric Dermatology), Erasmus MC, University Medical Center/Sophia Children’s Hospital, Rotterdam, The Netherlands; bDepartment of Dermatology and Allergy, AP-HP, Université Pierre et Marie Curie, Hôpital Tenon, Paris, France; cDepartment of Dermatology and STD, Victoria Hospital, Bangalore, India; dDivision of Dermatology, University of Cape Town, Cape Town, South Africa; eGlaxoSmithKline, Collegeville, Pa., USA; fGlaxoSmithKline, Greenford, UK
Background: Retapamulin is a novel pleuromutilin antibacterial developed for topical use. Objective: To compare the efficacy and safety of retapamulin ointment, 1% (twice daily for 5 days), with sodium fusidate ointment, 2% (3 times daily for 7 days), in impetigo. Methods: A randomized (2:1 retapamulin to sodium fusidate), observer-blinded, noninferiority, phase III study in 519 adult and pediatric (aged ≧9 months) subjects. Results: Retapamulin and sodium fusidate had comparable clinical efficacies (per-protocol population: 99.1 and 94.0%, respectively; difference: 5.1%, 95% confidence interval: 1.1–9.0%, p = 0.003; intent-to-treat population: 94.8 and 90.1%, respectively; difference: 4.7%, 95% confidence interval: –0.4 to 9.7%, p = 0.062). Bacteriological efficacies were similar. Success rates in the small numbers of sodium-fusidate-, methicillin- and mupirocin-resistant Staphylococcus aureus were good for retapamulin (9/9, 8/8 and 6/6, respectively). Both drugs were well tolerated. Conclusion: Retapamulin is a highly effective and convenient new treatment option for impetigo, with efficacy against isolates resistant to existing therapies.
© 2007 S. Karger AG, Basel