Topical retapamulin ointment (1%, wt/wt) twice daily for 5 days versus oral cephalexin twice daily for 10 days in the treatment of secondarily infected dermatitis: results of a randomized controlled trial.
BACKGROUND
New antibacterial agents with activity against pathogenic strains resistant to established antibiotics are needed to treat patients with secondarily infected dermatitis (SID).


OBJECTIVE
We sought to determine the clinical safety and efficacy of topical retapamulin ointment 1% versus oral cephalexin for the treatment of SID.


METHODS
Patients with SID were randomly assigned to retapamulin ointment 1% (twice daily [bid]) for 5 days, or oral cephalexin (500 mg bid) for 10 days. The primary efficacy end point was clinical response at follow-up. Secondary outcomes included microbiologic response at follow-up, safety, and compliance.


RESULTS
Retapamulin was as effective as cephalexin (clinical success rates at follow-up: 85.9% and 89.7%, respectively). Microbiologic success rates at follow-up were 87.2% for retapamulin and 91.8% for cephalexin. Retapamulin was well tolerated and the topical formulation was preferred over the oral drug.


CONCLUSIONS
An imbalance existed in the number of patients with the clinical outcome "unable to determine" (15 retapamulin, 2 cephalexin), mainly because of their failure to attend the study visit. If those who failed to attend visits (who did not withdraw as a result of drug-related events) are removed from the analysis, the clinical success rates are 89.9% for retapamulin and 89.7% for cephalexin.


CONCLUSIONS
Retapamulin ointment 1% (bid) for 5 days was as effective as oral cephalexin (bid) for 10 days in treatment of patients with SID, and was well tolerated.
Parish
Lawrence Charles
LC
Department of Dermatology and Cutaneous Biology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Jorizzo
Joseph Lucius
JL
Breton
John Jeffrey
JJ
Hirman
Joseph William
JW
Scangarella
Nicole Elizabeth
NE
Shawar
Ribhi Mohammad
RM
White
Scott Matthew
SM
D000279:Administration, Cutaneous; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000008:administration & dosage / Q000627:therapeutic use*; D002506:Cephalexin / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003872:Dermatitis / Q000150:complications*; D003876:Dermatitis, Atopic / Q000150:complications; D004224:Diterpenes; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D016106:Methicillin Resistance; D008875:Middle Aged; D009824:Ointments; D012874:Skin Diseases, Infectious / Q000188:drug therapy* / Q000209:etiology; D013207:Staphylococcal Skin Infections / Q000188:drug therapy* / Q000209:etiology; D013211:Staphylococcus aureus / Q000187:drug effects / Q000302:isolation & purification; D013290:Streptococcal Infections / Q000188:drug therapy* / Q000209:etiology; D013297:Streptococcus pyogenes / Q000187:drug effects / Q000302:isolation & purification*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D019086:Bridged Bicyclo Compounds, Heterocyclic; D004224:Diterpenes; D009824:Ointments; C508887:retapamulin; D002506:Cephalexin