An interventional study of Fractional Ablative CO₂ Laser and Triamcinolone Acetonide in Burn, Hypertrophic Scars and Scar Improvement by Laser, sponsored by University of California, Davis. Not yet recruiting. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
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 (TAC) 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.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 65 is above the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive fractional ablative CO₂ laser treatment followed by laser-assisted delivery of triamcinolone acetonide to the assigned hypertrophic burn scar segment. This arm serves as the active comparator for evaluating the additional effect of 5-fluorouracil when combined with triamcinolone acetonide.
Device: Fractional Ablative CO₂ Laser · Drug: Triamcinolone Acetonide
Participants will receive fractional ablative CO₂ laser treatment followed by laser-assisted delivery of triamcinolone acetonide plus 5-fluorouracil to the assigned hypertrophic burn scar segment. This arm will evaluate whether the addition of 5-fluorouracil improves hypertrophic burn scar outcomes compared with triamcinolone acetonide alone.
Device: Fractional Ablative CO₂ Laser · Drug: Triamcinolone Acetonide · Drug: Fluorouracil (5-FU)
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.
Also known as: 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.
Also known as: 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.
Also known as: 5-FU, 5-Fluorauracil, Efudex
Patient and Observer Scar Assessment Scale Version 3.0
The primary outcome will be the change in scar thickness and pliability as measured by the Patient and Observer Scar Assessment Scale Version 3.0 (POSAS 3.0). 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. The POSAS 3.0 Scale grades on a 5 point scale where both the patient and observer select one of the following for each scar description category: Not, Minimally, Moderately, Severely, or Extremely.
Time frame: Baseline to 3 months after final laser treatment. Will possibly do extended review at 12 months after final laser treatment.
Change in Vancouver Scar Scale Score
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. The Vancouver Scar scale grades on a scale of 0-3 for vascularity (Normal, pink, red, and purple). A scale of 0-5 is used for pliability (normal, supply, yielding, firm, ropes/bands, and contracture). A scale of 0-2 for pigmentation (normal, hypopigmentation, hyperpigmentation). A scale of 0-3 for height (flat, less than 2 mm, 2 to 5 mm, greater than 5 mm).
Time frame: Baseline to 3 months after final laser treatment. Possibly will do extended review 12 months after final laser treatment.
Change in Patient-Reported Scar Symptoms
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. The patient reported scar symptoms will be graded on a scale of 1-5 (not noticeable, noticeable, somewhat bothersome, very bothersome, and extremely bothersome).
Time frame: Baseline to 3 months after final laser treatment
Treatment-Related Adverse Events
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.
Time frame: From first treatment through 3 months after final laser treatment
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared. Deidentified aggregate results will be reported in future publications and presentations; however, participant-level data will not be made available due to privacy considerations, the potential identifiability of scar images and clinical characteristics, and limitations of the current IRB-approved protocol.
Start is estimated for Aug 2026; primary completion for Jul 2027, 10 months later.
Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 10 months is below that.
Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fluorouracil
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