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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

Study Summary

This trial is testing two drugs to see if they are safe and effective when delivered using a fractional erbium:YAG laser. 20 patients will receive 4 treatments spaced 4 weeks apart.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Modified Hamilton Score
Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit
Secondary outcome measures
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%
Bruising at site
5%
Burning at site
5%
Spreading/growth of scar
5%
Erythema of site
5%
Bleeding at site
100%
80%
60%
40%
20%
0%
Study treatment Arm
Site A of Keloid Scar - 5-FU
Site B of Keloid Scar - TAC

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
1,367 Previous Clinical Trials
839,741 Total Patients Enrolled
Nayoung Lee, MDPrincipal InvestigatorNYU Langone

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved the use of Fractional erbium:YAG-assisted drug delivery to administer 5-fluorouracil?

"The safety of Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil is highly regarded, with a score of 3. This conclusion was reached since this treatment has been approved and entered Phase 4 clinical trials."

Answered by AI

Has there been research into the efficacy of utilizing Fractional erbium:YAG-assisted delivery for administering 5-fluorouracil?

"At present, 355 clinical trials are researching the efficacy of Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil with 109 in Phase 3. Most studies for this intervention have taken place in Woolloongabba, Queensland; however there are 17948 locations conducting research on Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil worldwide."

Answered by AI

To what maladies is Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil most often recommended?

"Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil is a highly efficacious treatment for ulcerative colitis and other such medical conditions, including hand, brain and non-immunocompromised."

Answered by AI

How many participants are involved in the research project?

"Affirmative, clinicaltrials.gov showcases this trial as actively searching for participants. Originally posted on January 30th 2021 and last updated February 7th 2022, the study is welcoming 20 individuals to its single location."

Answered by AI

Is enlistment for this experiment ongoing?

"According to the information hosted on clinicaltrials.gov, this medical study is still searching for participants. The trial was initiated on January 30th 2021 and its most recent update occurred on February 7th 2022."

Answered by AI

What criteria must individuals meet to be eligible for this clinical trial?

"For this clinical trial, we are in search of 20 individuals aged 18-89 who possess one large keloid scar or multiple analogous marks."

Answered by AI

Is the requirement for this trial restricted to individuals aged 85 or younger?

"This trial requires that patients are between 18 and 89 years old. For those under the age of 18, there are 17 distinct clinical trials available whereas over 65s have access to 356 different studies."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
How old are they?
65+
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid
2021. "Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04786210.
~5 spots leftby Apr 2025
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