Efficacy and safety of retapamulin ointment as treatment of impetigo: randomized double-blind multicentre placebo-controlled trial.
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.


OBJECTIVE
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.
Koning
S
S
Department of General Practice, Erasmus MC-University Medical Center Rotterdam, PO Box 2040, 3000 CA Rotterdam, The Netherlands.
van der Wouden
J C
JC
Chosidow
O
O
Twynholm
M
M
Singh
K P
KP
Scangarella
N
N
Oranje
A P
AP
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004224:Diterpenes; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007169:Impetigo / Q000188:drug therapy* / Q000382:microbiology; D007223:Infant; D008297:Male; D008875:Middle Aged; D009824:Ointments; D013211:Staphylococcus aureus
D000900:Anti-Bacterial Agents; D019086:Bridged Bicyclo Compounds, Heterocyclic; D004224:Diterpenes; D009824:Ointments; C508887:retapamulin