Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

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.

Timeline

Start

2008-02

Primary completion

2009-03

Completion

2009-06

Drugs

Indications