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Anti-metabolites

Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil for Keloid Scars

Phase 4
Waitlist Available
Led By Nayoung Lee, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 16
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial uses a special laser to help deliver medications into the skin of patients with scars. The laser makes small holes in the skin, allowing the medicine to work more effectively. The goal is to see if this method improves scar appearance and healing. This technique has been found to enhance the local uptake of any drug or substance applied to the skin.

Eligible Conditions
  • Keloid Scars

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Modified Hamilton Score
Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit
Secondary study objectives
Change in Scar Measurement From Baseline to Final Visit

Side effects data

From 2022 Phase 4 trial • 20 Patients • NCT04786210
47%
Hyperpigmentation of site
42%
Itching at site
21%
Pain at site
16%
Swelling/edema at site
11%
Hypopigmentation of site
5%
Bleeding at site
5%
Bruising at site
5%
Spreading/growth of scar
5%
Erythema of site
5%
Burning at site
100%
80%
60%
40%
20%
0%
Study treatment Arm
Site A of Keloid Scar - 5-FU
Site B of Keloid Scar - TAC

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Site B of keloid scarExperimental Treatment1 Intervention
One half of keloid scarring on a single subject
Group II: Site A of keloid scarExperimental Treatment1 Intervention
One half of keloid scarring on a single subject
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil
2021
Completed Phase 4
~20
Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide
2021
Completed Phase 4
~20

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,410 Previous Clinical Trials
855,586 Total Patients Enrolled
Nayoung Lee, MDPrincipal InvestigatorNYU Langone
~4 spots leftby Dec 2025
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