Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT00626795
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT00626795
Study Brief:
Protocol Section:
NCT00626795