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
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2021
CompletedStudy Start
First participant enrolled
January 30, 2021
CompletedFirst Posted
Study publicly available on registry
March 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2022
CompletedResults Posted
Study results publicly available
March 26, 2024
CompletedMarch 26, 2024
February 1, 2024
1.9 years
January 25, 2021
February 2, 2024
February 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Change in Scar Measurement From Baseline to Final Visit
Baseline, Week 16
Study Arms (2)
Site A of keloid scar
EXPERIMENTALOne half of keloid scarring on a single subject
Site B of keloid scar
EXPERIMENTALOne half of keloid scarring on a single subject
Interventions
Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil solution to one half of the scar (4 treatments)
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)
Eligibility Criteria
You may qualify if:
- Age 18-89
- Has one large keloid scar or at least two similar but separate keloid scars
- Keloid present for at least 1 year
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nayoung Lee, MD
- Organization
- NYU Langone Health
Study Officials
- PRINCIPAL INVESTIGATOR
Nayoung Lee, MD
NYU Langone
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2021
First Posted
March 8, 2021
Study Start
January 30, 2021
Primary Completion
December 16, 2022
Study Completion
December 16, 2022
Last Updated
March 26, 2024
Results First Posted
March 26, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- Access Criteria
- Requests should be directed to nayoung.lee@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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.