Comparing the Safety and Efficacy of CO2 LADD TAC With and Without 5-FU for Hypertrophic Burn Sca… (NCT07660120) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparing the Safety and Efficacy of CO2 LADD TAC With and Without 5-FU for Hypertrophic Burn Scars: A Triple-Blinded, Split Scar RCT
65 participantsStarted 2026-07-01
Plain-language summary
Burn scars can sometimes heal in a way that causes them to become thick, raised, and stiff. These scars may itch, feel uncomfortable, limit movement, and affect how the skin looks. Because of this, many burn survivors look for treatments that can help improve both the appearance and the symptoms of their scars.
One treatment that has shown promise is fractional CO₂ laser therapy. This laser creates tiny openings in the scar tissue that help soften the scar and stimulate the skin to remodel itself. These openings can also help medications applied to the skin reach deeper into the scar where they may work better.
A steroid medication called triamcinolone is commonly used to treat these scars. Another medication, called 5-fluorouracil (5-FU), has been shown in prior studies to work well when combined with steroids, but it is usually given by injection, which can be painful and sometimes causes side effects.
In this study, we will look at whether delivering these medications through the laser openings can improve scars more effectively. Each participant's scar will be divided into two halves. One side will receive both medications, and the other side will receive the steroid alone. By comparing the two sides of the same scar, we hope to better understand whether adding 5-FU provides additional benefit.
Who can participate
Age range
18 Years – 89 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:
* Patient with hypertrophic scarring secondary to burn injury
* Ages 18-89
Exclusion Criteria:
* Pregnant patients or patients of childbearing age, sexually active, and unwilling to utilize contraception
* Children
* Individuals that are cognitively impaired and unable to provide consent
* Currently breastfeeding
* Has taken oral retinoids within 6 months of study initiation
* Prior laser or intralesional TAC/5-FU treatments for their hypertrophic scars
* Active infection
* Active malignancy
* Known hypersensitivity to CO2 laser, TAC, or 5-FU
* Known dihydropyrimidine dehydrogenase (DPD) deficiency (complete or partial), due to risk of systemic 5-FU toxicity
* Systemic corticosteroid or immunosuppressive medication use
* Intolerance to anesthesia
* Known connective tissue disease
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
Patient and Observer Scar Assessment Scale Version 2.0
Timeframe: Baseline to 3 months after final laser treatment. Will possibly do extended review at 12 months after final laser treatment.