A Phase 4 interventional study of Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil and Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide in Keloid Scar, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by NYU Langone Health · Phase 4, Interventional, and Treatment
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.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 20 is below the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One half of keloid scarring on a single subject
Combination Product: Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil
One half of keloid scarring on a single subject
Combination Product: Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide
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)
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.
Time frame: 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.
Time frame: Baseline, Week 16
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.
Time frame: Baseline, Week 16
| Milestone | Overall Study Population |
|---|---|
| Started | 19 |
| Received 5-fluorouracil (5-fu) | 19 |
| Received triamcinolone acetonide | 19 |
| Completed | 13 |
| Not completed | 6 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 4 |
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.
| score on a scale | Site A of Keloid Scar - 5-FU | Site B of Keloid Scar - TAC |
|---|---|---|
| Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit | -20 ± 8 | -20.6 ± 13.1 |
The Hamilton scale consists of 4 items with a score range of 0 to 14, where 14 represents more severe scarring.
| score on a scale | Site A of Keloid Scar - 5-FU | Site B of Keloid Scar - TAC |
|---|---|---|
| Change in Modified Hamilton Score | -0.88 ± 1.79 | -1.36 ± 1.21 |
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.
| cm^3 | Site A of Keloid Scar - 5-FU | Site B of Keloid Scar - TAC |
|---|---|---|
| Change in Scar Measurement From Baseline to Final Visit | -368.7 ± 692.9 | -310.7 ± 626.7 |
Collected over Through study completion, on average 1 year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Site A of Keloid Scar - 5-FU | — | 0/19 (0%) | 12/19 (63.2%) |
| Site B of Keloid Scar - TAC | — | 0/19 (0%) | 12/19 (63.2%) |
| Event | Site A of Keloid Scar - 5-FU | Site B of Keloid Scar - TAC |
|---|---|---|
| Hyperpigmentation of siteSkin and subcutaneous tissue disorders | 9/19 | 3/19 |
| Itching at siteSkin and subcutaneous tissue disorders | 8/19 | 6/19 |
| Pain at siteSkin and subcutaneous tissue disorders | 4/19 | 4/19 |
| Swelling/edema at siteSkin and subcutaneous tissue disorders | 3/19 | 1/19 |
| Hypopigmentation of siteSkin and subcutaneous tissue disorders | 2/19 | 0/19 |
| Bleeding at siteSkin and subcutaneous tissue disorders | 1/19 | 0/19 |
| Bruising at siteSkin and subcutaneous tissue disorders | 1/19 | 1/19 |
| Burning at siteSkin and subcutaneous tissue disorders | 1/19 | 1/19 |
| Erythema of siteSkin and subcutaneous tissue disorders | 1/19 | 1/19 |
| Spreading/growth of scarSkin and subcutaneous tissue disorders | 1/19 | 0/19 |
| Age, Continuous(years) | Overall Study Population |
|---|---|
| Median | 36 (26 to 46) |
| Sex: Female, Male(Participants) | Overall Study Population |
|---|---|
| Female | 9 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Overall Study Population |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Overall Study Population |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 7 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Overall Study Population |
|---|---|
| United States | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
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.
Ran from Jan 2021 to primary completion in Dec 2022, 22 months.
Results were first posted in Mar 2024, 1 year 3 months after primary completion. A results delay was requested in Dec 2023.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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