CO2 LADD TAC With and Without 5-FU for Hypertrophic Burn Scars: A Triple-Blinded, Split Scar RCT

NCT07660120 | Not Yet Recruiting DMC

• 1 other identifier: 2356901
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

burn scar; hypertrophic scar; CO2 Laser; laser assisted drug delivery

Outcome Measures

Primary Outcomes (1)

• Patient and Observer Scar Assessment Scale Version 2.0

  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.

  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

  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

  Baseline to 3 months after final laser treatment

Other Outcomes (1)

• Treatment-Related Adverse Events

  From first treatment through 3 months after final laser treatment

Study Arms (2)

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.

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.

Device: Fractional Ablative CO₂ Laser; Drug: Triamcinolone Acetonide; Drug: Fluorouracil (5-FU)

Interventions

Fractional Ablative CO₂ Laser DEVICE

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

CO₂ Laser + Triamcinolone Acetonide; CO₂ Laser + Triamcinolone Acetonide + 5-Fluorouracil

Triamcinolone Acetonide DRUG

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

CO₂ Laser + Triamcinolone Acetonide; CO₂ Laser + Triamcinolone Acetonide + 5-Fluorouracil

Fluorouracil (5-FU) DRUG

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

CO₂ Laser + Triamcinolone Acetonide + 5-Fluorouracil

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Related Publications (16)

• 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.

  PMID: 32681723 BACKGROUND

• 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.

  PMID: 30083505 BACKGROUND

• 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.

  PMID: 39355745 BACKGROUND

• 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.

  PMID: 30936735 BACKGROUND

• 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.

  PMID: 8537427 BACKGROUND

• 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.

  PMID: 16079683 BACKGROUND

• 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.

  PMID: 39847194 BACKGROUND

• 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.

  PMID: 30365461 BACKGROUND

• 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.

  PMID: 37856225 BACKGROUND

• 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.

  PMID: 40971504 BACKGROUND

• 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.

  PMID: 38347765 BACKGROUND

• 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.

  PMID: 32342167 BACKGROUND

• 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.

  PMID: 27105629 BACKGROUND

• 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.

  PMID: 19018794 BACKGROUND

• 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.

  PMID: 30340861 BACKGROUND

• 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.

  PMID: 37337341 BACKGROUND

MeSH Terms

Conditions

Burns; Cicatrix, Hypertrophic

Interventions

Triamcinolone Acetonide; Adrenal Cortex Hormones; Fluorouracil

Condition Hierarchy (Ancestors)

Wounds and Injuries; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ian A Powelson, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arman J Fijany, MD

CONTACT

(949) 351-5830; afijany@health.ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, treating clinicians, and outcome assessors will be masked to treatment allocation. Study medications will be prepared and labeled in a manner that does not reveal group assignment. Treatment segments will be identified using coded allocation records, and outcome assessments will be performed using standardized evaluations without disclosure of the assigned treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): July 10, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share