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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 COâ‚‚ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COâ‚‚ Laser + Triamcinolone Acetonide | Active Comparator | Participants will receive fractional ablative COâ‚‚ 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. |
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| COâ‚‚ Laser + Triamcinolone Acetonide + 5-Fluorouracil | Experimental | Participants will receive fractional ablative COâ‚‚ 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional Ablative COâ‚‚ Laser | Device | Fractional ablative COâ‚‚ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 COâ‚‚ laser-assisted drug delivery with triamcinolone acetonide plus 5-fluorouracil will be compared with contralateral or adjacent split-scar segments receiving fractional ablative COâ‚‚ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 COâ‚‚ laser-assisted delivery of triamcinolone acetonide plus 5-fluorouracil versus triamcinolone acetonide alone. | Baseline to 3 months after final laser treatment. Possibly will do extended review 12 months after final laser treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first treatment through 3 months after final laser treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arman J Fijany, MD | Contact | (949) 351-5830 | afijany@health.ucdavis.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ian A Powelson, MD | University of California, Davis | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32681723 | Background | 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. | |
| 30083505 | 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. |
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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.
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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 COâ‚‚ laser-assisted triamcinolone acetonide delivery and the paired segment assigned to fractional COâ‚‚ laser-assisted triamcinolone acetonide plus 5-fluorouracil delivery.
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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.
|
| Triamcinolone Acetonide | Drug | Triamcinolone acetonide will be administered to assigned hypertrophic burn scar segments following fractional ablative COâ‚‚ laser treatment as part of laser-assisted corticosteroid delivery. |
|
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| Fluorouracil (5-FU) | Drug | Fluorouracil will be administered in combination with triamcinolone acetonide to assigned hypertrophic burn scar segments following fractional ablative COâ‚‚ laser treatment to evaluate whether adjunctive 5-fluorouracil improves scar outcomes compared with triamcinolone acetonide alone. |
|
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| 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 COâ‚‚ laser-assisted delivery of triamcinolone acetonide plus 5-fluorouracil versus triamcinolone acetonide alone. | Baseline to 3 months after final laser treatment |
| 39355745 | 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. |
| 30936735 | 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. |
| 8537427 | 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. |
| 16079683 | 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. |
| 39847194 | 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. |
| 30365461 | 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. |
| 37856225 | 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. |
| 40971504 | 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. |
| 38347765 | 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. |
| 32342167 | 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. |
| 27105629 | 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. |
| 19018794 | 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. |
| 30340861 | 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. |
| 37337341 | 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. |
| ID | Term |
|---|---|
| D002056 | Burns |
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D000305 | Adrenal Cortex Hormones |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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