Conflicts of interest As employees of Erasmus MC – University Medical Center Rotterdam, SK and JCvdW received research funding from GlaxoSmithKline for taking part in this study. OC has acted as a paid consultant to GlaxoSmithKline and has received reimbursement for attending a symposium and a fee for speaking. MT, KPS and NS are employees of GlaxoSmithKline. APO has declared no conflicts of interest.
Efficacy and safety of retapamulin ointment as treatment of impetigo: randomized double-blind multicentre placebo-controlled trial
Version of Record online: 13 MAR 2008
© 2008 The Authors. Journal Compilation © 2008 British Association of Dermatologists
British Journal of Dermatology
Volume 158, Issue 5, pages 1077–1082, May 2008
How to Cite
Koning, S., Van Der Wouden, J.C., Chosidow, O., Twynholm, M., Singh, K.P., Scangarella, N. and Oranje, A.P. (2008), Efficacy and safety of retapamulin ointment as treatment of impetigo: randomized double-blind multicentre placebo-controlled trial. British Journal of Dermatology, 158: 1077–1082. doi: 10.1111/j.1365-2133.2008.08485.x
- Issue online: 13 MAR 2008
- Version of Record online: 13 MAR 2008
- Accepted for publication12 November 2007
Summary Background Impetigo is a common skin infection, primarily caused by Staphylococcus aureus and mainly occurring in children. It is usually treated topically with antibiotics to achieve a quick cure and prevent spread of the infection. Worldwide, resistance rates of S. aureus against commonly used antibiotics are rising. Retapamulin belongs to a newly developed class of antibiotics for the treatment of uncomplicated skin infections.
Objectives Our aim was to compare the efficacy and safety of topical application of retapamulin ointment with topical placebo ointment in the treatment of primary impetigo.
Methods In a randomized, double-blind, multicentre study, patients received either topical retapamulin ointment 1% twice daily for 5 days or topical placebo. Patients were enrolled into the study for 14 days and attended the clinic for three visits during which clinical and laboratory evaluations were performed.
Results Two hundred and thirteen patients were randomized, with 139 evaluable patients in the retapamulin group and 71 in the placebo group. Based on the primary efficacy endpoint of clinical response after 7 days (intention to treat), retapamulin ointment was superior to placebo (success rate 85·6% vs. 52·1%; P < 0·0001). Similar results were found in the per protocol analysis and in the subgroup of patients who had a pathogen isolated at baseline. The most common adverse effect, pruritus at the application site, was reported by 6% and 1% of patients in the retapamulin and placebo groups, respectively.
Conclusions This study shows that topical retapamulin is effective and safe in the treatment of primary impetigo, offering a new treatment option.