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

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

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.

Inclusion Criteria:

• Signed and dated informed consent from patient and/or legally acceptable representative has been obtained
• Outpatients of any sex or ethnic origin
• Patients >= 2 years of age (depending on study step)
• Patients must be suffering from primary bullous/non-bullous impetigo or SITL

Exclusion Criteria:

• Presence of skin diseases at or near the investigational area
• Immunosuppressed state or other serious systemic disease
• Signs and/or symptoms of systemic infection
• Presence of skin infection/disorder not amenable to topical antibacterial treatment only
• Presence of secondarily-infected animal/human bite
• Presence of secondarily infected burnwound
• Topical or systemic use of medicinal or other products before or during the study which in the investigators opinion could confound the evaluation of the effect of the study drugs
• Known or suspected hypersensitivity to TD1414 or any of the excipients in the TD1414 2% cream
• Known or suspected hypersensitivity to mupirocin or any of the excipients in the Bactroban® (mupirocin) 2% cream
• Participation in any other investigational drug study or use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to randomisation
• Patients previously enrolled/randomised in this study
• Abnormal ECG at baseline though the PR interval may be up to 220 ms, the QRS interval up to 110 ms and the QTc interval up to 450 ms