Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: TD1414 2% cream
  • BID 7 days
• Drug: TD1414 2% cream
  • TID 7 days
• Drug: Bactroban® (mupirocin) 2% cream
  • BID 7 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Active Comparator: 3

Primary Measures

• Clinical cure at end of treatment according to invstigator's assessment
  • Time Frame: End of treatment
    Safety Issue?: Yes

Secondary Measures

• Clinical cure at follow-up according to investigator's assessment. Clinical cure at end of treatment and follow-up according to investigator's assessment. Bacteriological cure at end of treatment, follow-up, and end of treatment and follow-up according
  • Time Frame: At Visit 2, at follow up, at end of treatment
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: LEO Pharma

Overall Clinical Trial Officials and Contacts

Almena L Free, MD Principal Investigator Anniston Medical Clinic  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00626795

Study ID Number: TD1414-C21

ClinicalTrials.gov Identifier: NCT00626795

Health Authority: United States: Food and Drug Administration