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.
Author(s): Tomayko JF(1), Li G, Breton JJ, Scangarella-Oman N, Dalessandro M, Martin M.
Affiliation(s): Author information:
(1)Department of Infectious Diseases, Medicines, Discovery and Development,
GlaxoSmithKline, Collegeville, Pennsylvania, USA.
Publication date & source: 2013, Adv Skin Wound Care. , 26(3):113-21
OBJECTIVE: To evaluate whether retapamulin 1% is clinically superior to a placebo
in the treatment of patients with secondarily infected traumatic lesions.
DESIGN: The study was a double-blind, placebo-controlled, parallel-group, phase 3
study.
SETTING: Patients were recruited from 5 countries.
PATIENTS: The aforementioned patients were all 2 months or older and diagnosed
with secondarily infected traumatic lesions.
INTERVENTIONS: Study medication was applied twice daily for 5 days.
MAIN OUTCOME MEASURES: 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.
MAIN 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).
CONCLUSION: 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.
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