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Completed

NCT Number: NCT04786210

Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid

This is a split-scar study with a target sample size of 20. There are two interventions: fractional erbium:YAG-assisted drug delivery of 5-fluorouracil and fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide. Patients will undergo treatments in a series of 4 treatments at approximately 4 week ± 1 week intervals. Investigators will monitor for safety and continued benefit after the end of the interventional treatment.

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Key information

Conditions

Keloid Scar Cicatrix Collagen Diseases Connective Tissue Diseases Fibrosis Keloid Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-89
  • Has one large keloid scar or at least two similar but separate keloid scars
  • Keloid present for at least 1 year

Exclusion criteria

  • Currently pregnant
  • Currently breastfeeding
  • Have taken oral retinoids within 6 months of study initiation
  • Has had keloid treatment within 1 month of study initiation
  • Has active infection at treatment site
  • Has active malignancy
  • Presence of pedunculated keloid(s) or keloid(s) that are judged to be best treated with surgical excision first
  • Hypertrophic scars
  • Known hypersensitivity to TAC or 5-FU
  • Chronic systemic corticosteroid or immunosuppressive medication use
  • Has intolerance to anesthesia
  • Has known connective tissue disease
  • Has known infectious disease

Treatment and study plan

Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil

Combination Product

Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil solution to one half of the scar (4 treatments)

Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide

Combination Product

Split-scar fractional ablative erbium laser-assisted delivery of 10 mg/mL of triamcinolone acetonide solution to the other half of the scar (4 treatments)

Primary outcomes

  1. Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit

    Time frame: Baseline, Week 16

    POSAS has two components, the observer (physician) portion and the patient portion. The observer grades on a scale of 1 to 10, 10 being the worst scar imaginable, six measures: vascularity, pigmentation, thickness, relief, pliability and surface area. The patient answers six questions regarding the characteristics of the scar, with each question being on a scale of 1 to 10. The scores of each category are summed to get the total POSAS score, with 120 being the highest score and representing the worst scar and 12 being the lowest score.

  2. Change in Modified Hamilton Score

    Time frame: Baseline, Week 16

    The Hamilton scale consists of 4 items with a score range of 0 to 14, where 14 represents more severe scarring.

Secondary outcomes

  1. Change in Scar Measurement From Baseline to Final Visit

    Time frame: Baseline, Week 16

    Scar measurement will be calculated as the total volume (length x width x height) in cm3 of the scar, or (length x width) in cm2 if the scars are flush with the surrounding skin scar surface.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Prospective Triple-Blinded Single-Center Study of Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid Treatment for Keloids

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2021
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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