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

Официальное название

Comparing the Safety and Efficacy of CO2 Laser-Assisted Triamcinolone Delivery With and Without 5-Fluorouracil for Hypertrophic Burn Scars: A Triple-Blinded, Randomized Split Scar Clinical Trial

Обзор

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.

Вмешательства

• Устройство Fractional 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.
• Препарат Triamcinolone Acetonide
  Triamcinolone acetonide will be administered to assigned hypertrophic burn scar segments following fractional ablative CO₂ laser treatment as part of laser-assisted corticosteroid delivery.
• Препарат Fluorouracil (5-FU)
  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.

Первичные конечные точки

• Patient and Observer Scar Assessment Scale Version 2.0 [Срок оценки: Baseline to 3 months after final laser treatment. Will possibly do extended review at 12 months after final laser treatment.]

Вторичные конечные точки (2)

• Change in Vancouver Scar Scale Score [Срок оценки: 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 [Срок оценки: Baseline to 3 months after final laser treatment]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07660120 · 2356901

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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