title: The safety and efficacy of topical retapamulin ointment versus placebo ointment in the treatment of secondarily infected traumatic lesions: a randomized, double-blind superiority study.
abstract: OBJECTIVE
  To evaluate whether retapamulin 1% is clinically superior to a placebo in the treatment of patients with secondarily infected traumatic lesions.
  
  
  METHODS
  The study was a double-blind, placebo-controlled, parallel-group, phase 3 study.
  
  
  METHODS
  Patients were recruited from 5 countries.
  
  
  METHODS
  The aforementioned patients were all 2 months or older and diagnosed with secondarily infected traumatic lesions.
  
  
  METHODS
  Study medication was applied twice daily for 5 days.
  
  
  METHODS
  Primary end point: clinical response (success/failure) at follow-up. Secondary efficacy end points included clinical and microbiological outcomes at end of therapy (on days 7-9); microbiological and therapeutic responses at follow-up.
  
  
  RESULTS
  A total of 508 patients were recruited for the study; 359 patients were included in the primary efficacy analysis population (246 received retapamulin; 113 received the placebo). Secondarily infected abrasions were the most common secondarily infected traumatic lesions present (56.3%), Staphylococcus aureus being the most frequently isolated pathogen at baseline (60.1%); 15.1% infections were methicillin-resistant. At follow-up, patients receiving retapamulin had higher clinical success rates than those receiving the placebo (74.8% vs 66.4%, respectively) in the primary efficacy analysis population; however, the treatment difference was not statistically significant (8.4%; 95% confidence interval, -1.6 to 18.4). The proportion of patients experiencing adverse events, which were typically mild or moderate in severity, was similar between the retapamulin (5.6%, 19/342) and placebo groups (4.8%, 8/165).
  
  
  CONCLUSIONS
  Clinical success rates were higher with retapamulin versus placebo in the treatment of patients with secondarily infected traumatic lesions, but the difference between treatment groups was not significant. Retapamulin was well tolerated.
authors: Department of Infectious Diseases, Medicines, Discovery and Development, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
authors: John F
authors: JF
authors: Tomayko
authors: Gang
authors: G
authors: Li
authors: John J
authors: JJ
authors: Breton
authors: Nicole
authors: N
authors: Scangarella-Oman
authors: Marybeth
authors: M
authors: Dalessandro
authors: Michael
authors: M
authors: Martin
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004224:Diterpenes; D004311:Double-Blind Method; D024881:Drug Resistance, Bacterial; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D009824:Ointments / Q000008:administration & dosage* / Q000009:adverse effects; D015990:Placebo Effect; D013207:Staphylococcal Skin Infections / Q000188:drug therapy*; D013290:Streptococcal Infections / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D019086:Bridged Bicyclo Compounds, Heterocyclic; D004224:Diterpenes; D009824:Ointments; C508887:retapamulin