Keloid ScarPhase 4NCT04786210
Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid
A Phase 4 study testing Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil and Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide in people with Keloid Scar, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Keloid Scar
- What is being tested?
- Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil and Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2021to 16 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-89
- Has one large keloid scar or at least two similar but separate keloid scars
- Keloid present for at least 1 year
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Keloid Scar
- Being tested
- Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil, Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional erbium:YAG-assisted drug delivery of 5-fluorouracilCombination product
Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil solution to one half of the scar (4 treatments)
Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonideCombination product
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)
| Study group | Role | What they receive |
|---|---|---|
| Site A of keloid scar | Experimental | One half of keloid scarring on a single subject Receives: Combination Product: Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil |
| Site B of keloid scar | Experimental | One half of keloid scarring on a single subject Receives: Combination Product: Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 16
Secondary outcomes (1)
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.
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start30 Jan 2021
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Keloid ScarStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nayoung Lee, MD, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786210
- Sponsor's protocol ID
- 20-01172
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2021
- Last updated
- 26 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Triple-Blinded Single-Center Study of Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid Treatment for Keloids
- ClinicalTrials.gov ID
- NCT04786210
- Acronym / sponsor ID
- 20-01172
- Conditions
- Keloid Scar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Posted 26 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Site A of keloid scar | Experimental | Combination Product: Fractional erbium:YAG-assisted drug delivery of 5-fluorouracilOne half of keloid scarring on a single subject |
| Site B of keloid scar | Experimental | Combination Product: Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonideOne half of keloid scarring on a single subject |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-89
- Has one large keloid scar or at least two similar but separate keloid scars
- Keloid present for at least 1 year
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional erbium:YAG-assisted drug delivery of 5-fluorouracilSplit-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil solution to one half of the scar (4 treatments) | Combination product | Site A of keloid scar |
| Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonideSplit-scar fractional ablative erbium laser-assisted delivery of 10 mg/mL of triamcinolone acetonide solution to the other half of the scar (4 treatments) | Combination product | Site B of keloid scar |
Primary outcome
Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit
Time frame: Baseline, Week 16
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.
Change in Modified Hamilton Score
Time frame: Baseline, Week 16
The Hamilton scale consists of 4 items with a score range of 0 to 14, where 14 represents more severe scarring.
1 secondary outcome
Change in Scar Measurement From Baseline to Final Visit
Time frame: Baseline, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayoung Lee, MD principal investigator
NYU Langone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil and Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide in people with Keloid Scar, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit (time frame: Baseline, Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.