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

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

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.

Study Overview

• Status: Completed
• Conditions: Keloid Scar
• Intervention / Treatment: Combination product: Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil; Combination product: Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nayoung Lee, MD; Phone Number: 212-263-7019; Email: nayoung.lee@nyulangone.org
• Study Contact Backup: Name: Lisa Akintilo, MD, MPH; Email: lisa.akintilo@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

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

Exclusion Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Site A of keloid scar; One half of keloid scarring on a single subject	Combination product: Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil; Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil solution to one half of the scar (4 treatments)
Experimental: Site B of keloid scar; One half of keloid scarring on a single subject	Combination product: Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit	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.	Baseline, Week 16
Change in Modified Hamilton Score	The Hamilton scale consists of 4 items with a score range of 0 to 14, where 14 represents more severe scarring.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Scar Measurement From Baseline to Final Visit	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.	Baseline, Week 16

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Nayoung Lee, MD, NYU Langone

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2021
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Keloid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fluorouracil; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 20-01172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Requests should be directed to nayoung.lee@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes