BurnNCT07660120
Carbon Dioxide Laser-Assisted Delivery of Triamcinolone With or Without 5-Fluorouracil for Hypertrophic Burn Scars
A study testing Fractional Ablative CO₂ Laser, Triamcinolone Acetonide and Fluorouracil (5-FU) in people with Burn and Hypertrophic Scars, run by University of California, Davis.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Burn, Hypertrophic Scars, Scar Improvement by Laser
- What is being tested?
- Fractional Ablative CO₂ Laser, Triamcinolone Acetonide and Fluorouracil (5-FU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 22 Aug 2026to 10 Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with hypertrophic scarring secondary to burn injury
- Ages 18-89
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing the Safety and Efficacy of Carbon Dioxide Laser-Assisted Triamcinolone Delivery With and Without 5-Fluorouracil for Hypertrophic Burn Scars: A Triple-Blinded, Randomized Split Scar Clinical Trial
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.
Read more
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.
- Being tested
- Fractional Ablative CO₂ Laser, Triamcinolone Acetonide, Fluorouracil (5-FU)
- Keywords
- burn scar, hypertrophic scar, CO2 Laser, laser assisted drug delivery
- Medical subject headings
- Burns, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Ablative CO₂ LaserDevice
Also called CO₂ laser, Fractional carbon dioxide laser, Ablative fractional laser
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.
Triamcinolone AcetonideDrug
Also called Kenalog, TAC, Corticosteroid
Triamcinolone acetonide will be administered to assigned hypertrophic burn scar segments following fractional ablative CO₂ laser treatment as part of laser-assisted corticosteroid delivery.
Fluorouracil (5-FU)Drug
Also called 5-FU, 5-Fluorauracil, Efudex
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.
| Study group | Role | What they receive |
|---|---|---|
| CO₂ Laser + Triamcinolone Acetonide | Active comparator | 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. Receives: Device: Fractional Ablative CO₂ Laser; Drug: Triamcinolone Acetonide |
| CO₂ Laser + Triamcinolone Acetonide + 5-Fluorouracil | Experimental | 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. Receives: Device: Fractional Ablative CO₂ Laser; Drug: Triamcinolone Acetonide; Drug: Fluorouracil (5-FU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months after final laser treatment. Will possibly do extended review at 12 months after final laser treatment.
Secondary outcomes (2)
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).
Measured: 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).
Measured: Baseline to 3 months after final laser treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start22 Aug 2026 (estimated)
- Primary completion10 Jul 2027 (estimated)
- Study completion10 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will serve as their own controls in a split-scar, randomized design. Each eligible hypertrophic burn scar will be divided into treatment segments, with one segment assigned to fractional CO₂ laser-assisted triamcinolone acetonide delivery and the paired segment assigned to fractional CO₂ laser-assisted triamcinolone acetonide plus 5-fluorouracil delivery.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian A Powelson, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660120
- Sponsor's protocol ID
- 2356901
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Zhang CQ, Gogal C, Gaugler T, Blome-Eberwein S. A 6-Year Experience of Laser Treatments for Burn Scars in a Regional Burn Center-Safety, Efficacy, and Quality Improvement. J Burn Care Res. 2021 Feb 3;42(1):74-81. doi: 10.1093/jbcr/iraa118.
PubMed 32681723Srivastava S, Patil A, Prakash C, Kumari H. Comparison of Intralesional Triamcinolone Acetonide, 5-Fluorouracil, and Their Combination in Treatment of Keloids. World J Plast Surg. 2018 May;7(2):212-219.
PubMed 30083505Acharya R, Agrawal S, Khadka DK, Pant AR. Efficacy and safety of intralesional triamcinolone acetonide alone and its combination with 5- fluorouracil in keloids and hypertrophic scars: Randomized, parallel group, and double blinded trial. Skin Health Dis. 2024 Aug 24;4(5):e450. doi: 10.1002/ski2.450. eCollection 2024 Oct.
PubMed 39355745Tawfik AA, Fathy M, Badawi A, Abdallah N, Shokeir H. Topical 5 fluorouracil cream vs combined 5 fluorouracil and fractional erbium YAG laser for treatment of severe hypertrophic scars. Clin Cosmet Investig Dermatol. 2019 Mar 14;12:173-180. doi: 10.2147/CCID.S191137. eCollection 2019.
PubMed 30936735Baryza MJ, Baryza GA. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil. 1995 Sep-Oct;16(5):535-8. doi: 10.1097/00004630-199509000-00013.
PubMed 8537427van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
PubMed 16079683Younes B, Mandour E, Soliman Hashish M, Gamal Shoukr T. The efficacy of fractional CO2 laser with or without triamcinolone acetonide or 5-fluorouracil in the treatment of early postburn hypertrophic scars. Lasers Med Sci. 2025 Jan 23;40(1):33. doi: 10.1007/s10103-024-04256-z.
PubMed 39847194Waibel JS, Wulkan AJ, Rudnick A, Daoud A. Treatment of Hypertrophic Scars Using Laser-Assisted Corticosteroid Versus Laser-Assisted 5-Fluorouracil Delivery. Dermatol Surg. 2019 Mar;45(3):423-430. doi: 10.1097/DSS.0000000000001678.
PubMed 30365461Won P, Cooper M, Gillenwater TJ, Yenikomshian HA. Treatment of Hypertrophic Burn Scars With Laser Therapy: A Review of Adverse Events. Ann Plast Surg. 2023 Dec 1;91(6):715-719. doi: 10.1097/SAP.0000000000003712. Epub 2023 Sep 19.
PubMed 37856225Shilova M, Plummer K, Ware R, Kimble R, Clark J, Cho E, McMillan L, Kimble L, Meikle B, Kunde L, Griffin B. Laser-Assisted Drug Delivery for Hypertrophic Scar Treatment: A Scoping Review. J Burn Care Res. 2026 Jan 6;47(1):130-146. doi: 10.1093/jbcr/iraf167.
PubMed 40971504Bernabe RM, Choe D, Calero T, Lin J, Pham C, Dang J, Madrigal P, Yenikomshian HA, Gillenwater TJ. Laser-Assisted Drug Delivery in the Treatment of Hypertrophic Scars and Keloids: A Systematic Review. J Burn Care Res. 2024 May 6;45(3):590-600. doi: 10.1093/jbcr/irae023.
PubMed 38347765Jiang ZY, Liao XC, Liu MZ, Fu ZH, Min DH, Yu XT, Guo GH. Efficacy and Safety of Intralesional Triamcinolone Versus Combination of Triamcinolone with 5-Fluorouracil in the Treatment of Keloids and Hypertrophic Scars: A Systematic Review and Meta-analysis. Aesthetic Plast Surg. 2020 Oct;44(5):1859-1868. doi: 10.1007/s00266-020-01721-2. Epub 2020 Apr 27.
PubMed 32342167Shah VV, Aldahan AS, Mlacker S, Alsaidan M, Samarkandy S, Nouri K. 5-Fluorouracil in the Treatment of Keloids and Hypertrophic Scars: A Comprehensive Review of the Literature. Dermatol Ther (Heidelb). 2016 Jun;6(2):169-83. doi: 10.1007/s13555-016-0118-5. Epub 2016 Apr 22.
PubMed 27105629Darougheh A, Asilian A, Shariati F. Intralesional triamcinolone alone or in combination with 5-fluorouracil for the treatment of keloid and hypertrophic scars. Clin Exp Dermatol. 2009 Mar;34(2):219-23. doi: 10.1111/j.1365-2230.2007.02631.x. Epub 2008 Nov 6.
PubMed 19018794Khalid FA, Mehrose MY, Saleem M, Yousaf MA, Mujahid AM, Rehman SU, Ahmad S, Tarar MN. Comparison of efficacy and safety of intralesional triamcinolone and combination of triamcinolone with 5-fluorouracil in the treatment of keloids and hypertrophic scars: Randomised control trial. Burns. 2019 Feb;45(1):69-75. doi: 10.1016/j.burns.2018.08.011. Epub 2018 Oct 16.
PubMed 30340861