Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
Summary
An international, multi-centre, prospective three arm parallel-group, phase II proof of
concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7
days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2%
cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an
evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A
total of 664 patients will be enrolled in a stepwise manner according to age groups starting
with the oldest age group.