Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Trauma… (NCT00626795) | Clinical Trial Compass
CompletedPhase 2
Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
United States, South Africa773 participantsStarted 2008-02
Plain-language 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.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants With Clinical Cure According to Investigator's Assessment