Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Site A of keloid scar | Experimental | One half of keloid scarring on a single subject |
|
| Site B of keloid scar | Experimental | One half of keloid scarring on a single subject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil | Combination Product | Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil solution to one half of the scar (4 treatments) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 16 |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nayoung Lee, MD | NYU Langone | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Requests should be directed to nayoung.lee@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study Population | One half of keloid scarring (Site A of keloid scar) on a single subject will be assigned to 5-FU: Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil (5-FU) solution to one half of the scar (4 treatments) The other half of keloid scarring (Site B of keloid scar) on a single subject will be assigned to TAC: Split-scar fractional ablative erbium laser-assisted delivery of 10 mg/mL of triamcinolone acetonide (TAC) solution to the other half of the scar (4 treatments). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide | Combination 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) |
|
| Received 5-fluorouracil (5-FU) |
|
| Received Triamcinolone Acetonide |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | One half of keloid scarring (Site A of keloid scar) on a single subject will be assigned to 5-FU: Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil (5-FU) solution to one half of the scar (4 treatments) The other half of keloid scarring (Site B of keloid scar) on a single subject will be assigned to TAC: Split-scar fractional ablative erbium laser-assisted delivery of 10 mg/mL of triamcinolone acetonide (TAC) solution to the other half of the scar (4 treatments). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16 | Keloid scar | Keloid scar |
|
|
| |||||||||||||||||||||||||||||
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16 | Keloid scar | Keloid scar |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | cm^3 | Baseline, Week 16 | Keloid scar | Keloid scar |
|
|
Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Site A of Keloid Scar - 5-FU | One half of keloid scarring on a single subject Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil: Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil solution to one half of the scar (4 treatments) | 0 | 0 | 0 | 19 | 12 | 19 |
| EG001 | Site B of Keloid Scar - TAC | One half of keloid scarring on a single subject Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide: 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) | 0 | 0 | 0 | 19 | 12 | 19 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding at site | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Bruising at site | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Swelling/edema at site | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Burning at site | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema of site | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperpigmentation of site | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypopigmentation of site | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Itching at site | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pain at site | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Spreading/growth of scar | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nayoung Lee, MD | NYU Langone Health | 212-263-7019 | nayoung.lee@nyulangone.org |
| Feb 2, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007627 | Keloid |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Keloid scar |
|
|
| Keloid scar |
|
|