ClinicalTrials.gg
Not yet recruitingNCT07660120Updated Aug 24, 2026

Carbon Dioxide Laser-Assisted Delivery of Triamcinolone With or Without 5-Fluorouracil for Hypertrophic Burn Scars

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

Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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 (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.

02

Conditions studied

  • Burn
  • Hypertrophic Scars
  • Scar Improvement by Laser
  • CO2 Laser in Scars

Keywords

  • burn scar
  • hypertrophic scar
  • CO2 Laser
  • laser assisted drug delivery
03

In context

Burns

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Patient with hypertrophic scarring secondary to burn injury
  • Ages 18-89

Exclusion criteria

Exclusion Criteria:

  • Pregnant patients or patients of childbearing age, sexually active, and unwilling to utilize
  • 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
  • Known to CO2 laser, TAC, or 5-FU
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency (complete or partial), due to risk of systemic 5-FU toxicity
  • Systemic or medication use
  • Intolerance to anesthesia
  • Known connective tissue disease
Terms in these criteria, in plain language(5)

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
65 participants (estimated)

Study arms

  • Active comparator
    CO₂ Laser + Triamcinolone Acetonide

    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

  • Experimental
    CO₂ Laser + Triamcinolone Acetonide + 5-Fluorouracil

    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)

Interventions

  • DeviceFractional Ablative CO₂ 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.

    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

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Other outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

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 32681723 ↗
  • Srivastava 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 30083505 ↗
  • Acharya 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 39355745 ↗
  • Tawfik 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 30936735 ↗
  • Baryza 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 8537427 ↗
  • van 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 16079683 ↗
  • Younes 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 39847194 ↗
  • Waibel 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 30365461 ↗
  • Won 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 37856225 ↗
  • Shilova 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 40971504 ↗
  • Bernabe 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 38347765 ↗
  • Jiang 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 32342167 ↗
  • Shah 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 27105629 ↗
  • Darougheh 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 19018794 ↗
  • Khalid 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 ↗
  • Mavilakandy AK, Vayalapra S, Minty I, Parekh JN, Charles WN, Khajuria A. Comparing Combination Triamcinolone Acetonide and 5-Fluorouracil with Monotherapy Triamcinolone Acetonide or 5-Fluorouracil in the Treatment of Hypertrophic Scars: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2024 Jun 1;153(6):1318-1330. doi: 10.1097/PRS.0000000000010867. Epub 2023 Jun 20. PubMed 37337341 ↗

Individual participant data

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Jun 15, 2026
First posted
Jun 22, 2026
StartEst.
Aug 22, 2026
Primary completionEst.
Jul 10, 2027
CompletionEst.
Jul 10, 2028
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07660120
Responsible party
Sponsor
First posted
Jun 22, 2026
Start date
Aug 22, 2026 (estimated)
Primary completion
Jul 10, 2027 (estimated)
Completion
Jul 10, 2028 (estimated)
Last update
Aug 24, 2026

Study contacts

Arman J Fijany, MD
Contact
afijany@health.ucdavis.edu
(949) 351-5830
Ian A Powelson, MD
principal investigator · University of California, Davis

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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Studies of the drug tested here: Fluorouracil

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