Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL) (NCT00684177) | Clinical Trial Compass
CompletedPhase 3
Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)
United States, Argentina, Brazil508 participantsStarted 2008-05
Plain-language summary
The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of age and older will be treated with topical retapamulin or placebo ointment twice daily for 5 days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14; 7-9 days after the end of therapy) in the intent-to-treat clinical population.
Who can participate
Age range
2 Months
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:
* subject is aged 2 months or older
* subject has secondarily-infected traumatic lesion (laceration, sutured wound or abrasion)
* negative urine pregnancy test
* subject has total skin infection rating scale score of at least 8, including pus/exudate score of at least 3
* subject and/or parent/legal guardian is willing and able to comply with protocol
* subject or parent/legal guardian has given written informed consent or assent as applicable
Exclusion criteria:
* previous hypersensitivity to pleuromutilin
* secondarily-infected animal/human bite or puncture wound
* subject has an abscess
* chronic ulcerative lesion
* underlying skin disease
* systemic signs and symptoms of infection
* infection not appropriately treated with topical antibiotic
* infection requires surgical intervention prior to or during study
* subject received systemic antibacterial or steroid, or topical therapeutic agent within 24 hours of entry into study
* serious underlying disease
* subject pregnant, breast feeding or planning a pregnancy, or unacceptable method of contraception
* other investigational drug within 30 days of study entry
* subject previously enrolled in this study
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
Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population