Conditions: Impetigo Secondarily Infected Traumatic Lesions
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 773
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: TD1414 2% cream intervention 2: TD1414 2% cream intervention 3: Bactroban® (mupirocin) 2% cream
Intervention descriptions: intervention 1: BID 7 days intervention 2: TID 7 days intervention 3: BID 7 days

Protocol document: