NCT Number: NCT07660120
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.
Trial opening soon.
Get Notified18 year–89 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fractional ablative CO₂ laser treatment will be applied to assigned hypertrophic burn scar segments to create microthermal treatment zones and facilitate laser-assisted delivery of topical/intralesional study medication.
Other names: CO₂ laser, Fractional carbon dioxide laser, Ablative fractional laser
Triamcinolone acetonide will be administered to assigned hypertrophic burn scar segments following fractional ablative CO₂ laser treatment as part of laser-assisted corticosteroid delivery.
Other names: Kenalog, TAC, Corticosteroid
Fluorouracil will be administered in combination with triamcinolone acetonide to assigned hypertrophic burn scar segments following fractional ablative CO₂ laser treatment to evaluate whether adjunctive 5-fluorouracil improves scar outcomes compared with triamcinolone acetonide alone.
Other names: 5-FU, 5-Fluorauracil, Efudex
Time frame: Baseline to 3 months after final laser treatment. Will possibly do extended review at 12 months after final laser treatment.
The primary outcome will be the change in scar thickness and pliability as measured by the Patient and Observer Scar Assessment Scale Version 2.0 (POSAS 2.0). Treated scar segments receiving fractional ablative CO₂ laser-assisted drug delivery with triamcinolone acetonide plus 5-fluorouracil will be compared with contralateral or adjacent split-scar segments receiving fractional ablative CO₂ laser-assisted delivery with triamcinolone acetonide alone.
Time frame: Baseline to 3 months after final laser treatment. Possibly will do extended review 12 months after final laser treatment.
Secondary outcome will include change in Vancouver Scar Scale score, including vascularity, pigmentation, pliability, and height, comparing scar segments treated with fractional ablative CO₂ laser-assisted delivery of triamcinolone acetonide plus 5-fluorouracil versus triamcinolone acetonide alone.
Time frame: Baseline to 3 months after final laser treatment
Patient-reported scar symptoms, including pain and pruritus, will be assessed before and after treatment. Symptom scores will be compared between split-scar segments treated with fractional ablative CO₂ laser-assisted delivery of triamcinolone acetonide plus 5-fluorouracil versus triamcinolone acetonide alone.
Time frame: From first treatment through 3 months after final laser treatment
Treatment-related adverse events will be recorded, including ulceration, infection, pigmentary change, skin atrophy, delayed wound healing, or other local complications at treated scar sites.
Contact information is provided by the study sponsor or research team.
University of California, Davis
Other
Comparing the Safety and Efficacy of CO2 Laser-Assisted Triamcinolone Delivery With and Without 5-Fluorouracil for Hypertrophic Burn Scars: A Triple-Blinded, Randomized Split Scar Clinical Trial
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