Overview

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