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NCT04786210 · ClinicalTrials.gov registry record · Phase 4
Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid
A Phase 4 study of Keloid Scar, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04786210: Completed Phase 4 study of Keloid Scar, sponsored by NYU Langone Health.
NCT04786210 is a Phase 4 study of Keloid Scar that has completed, run by NYU Langone Health. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04786210, a Phase 4 study of Keloid Scar, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- COMBINATION_PRODUCT Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil
- COMBINATION_PRODUCT Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-01-30 |
| Est. Completion | 2022-12-16 |
| Phase | Phase 4 |
What the finished NCT04786210 record still lists
NCT04786210 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Keloid Scar appearing as the primary indexed condition, and to 2 interventions - of which Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil is the first listed.
NCT04786210 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04786210 about?
NCT04786210 is a clinical study titled "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 approxi...
What is the current status of trial NCT04786210?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2021-01-30. Estimated completion is 2022-12-16.
What conditions does trial NCT04786210 study?
This clinical trial studies the following conditions: Keloid Scar.
What interventions are being tested in trial NCT04786210?
The interventions under investigation include: Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil (COMBINATION_PRODUCT), Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04786210?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04786210 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04786210's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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