Status:
COMPLETED
Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
Lead Sponsor:
LEO Pharma
Conditions:
Impetigo
Secondarily Infected Traumatic Lesions
Eligibility:
All Genders
2+ years
Phase:
PHASE2
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% ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
773 Patients enrolled
Trial Details
Trial ID
NCT00626795
Start Date
February 1 2008
End Date
June 1 2009
Last Update
March 12 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Anniston Medical Clinic
Anniston, Alabama, United States, 36207
2
Division of Dermatology, Groote Schuur Hospital, G23
Cape Town, Western Cape, South Africa, 7925