INTRODUCTION: Retapamulin is a novel, topical antibacterial of the pleuromutilin 
class in development for the treatment of secondarily infected traumatic lesions 
of the skin.
METHODS: The efficacy, safety, and tolerability of topical retapamulin ointment, 
1% for 5 days twice daily was evaluated in 2 identical, randomized, 
double-blind, double-dummy, multicenter studies vs oral cephalexin, 500 mg twice 
daily for 10 days, in 1904 patients with secondarily infected traumatic lesions.
RESULTS: Clinical success rates were 89.5% in protocol-adherent patients 
receiving retapamulin compared with 91.9% for cephalexin (treatment difference, 
-2.5% [95% confidence interval, -5.4% to 0.5%]). In patients with Staphylococcus 
aureus or Streptococcus pyogenes at baseline, clinical success was 89.2% 
(365/409) for retapamulin and 92.6% (63/68) for cephalexin. Safety and 
tolerability were similar between treatments. Noncompliance (defined as using or 
taking <80% of doses) was recorded in 8.0% (51/636) of patients taking 
cephalexin compared with 0.39% (5/1268) of patients receiving retapamulin.
CONCLUSIONS: Retapamulin offers a novel, effective, and convenient topical 
treatment for secondarily infected traumatic lesions.