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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma
• Treatments: Mupirocin

Criteria

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