Summary

Eligibility
for people ages 18-89 (full criteria)
Dates
study started
study ends around
Principal Investigator
by Ian A Powelson, MD (ucdavis)

Description

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.

Official Title

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

Keywords

Burn, Hypertrophic Scars, Scar Improvement by Laser, CO2 Laser in Scars, burn scar, hypertrophic scar, CO2 Laser, laser assisted drug delivery, Burns, Hypertrophic Cicatrix, Triamcinolone Acetonide, Adrenal Cortex Hormones, Fluorouracil, Fractional Ablative CO₂ Laser, Fluorouracil (5-FU), CO₂ Laser + Triamcinolone Acetonide, CO₂ Laser + Triamcinolone Acetonide + 5-Fluorouracil

Eligibility

You can join if…

Open to people ages 18-89

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

You CAN'T join 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

Lead Scientist at University of California Health

  • Ian A Powelson, MD (ucdavis)
    Assistant Professor, Med: Surgery, School of Medicine. Authored (or co-authored) 9 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT07660120
Study Type
Interventional
Participants
Expecting 65 study participants
Last Updated