Keloid Scar
Conditions
Brief 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.
Interventions
COMBINATION_PRODUCTFractional 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)
COMBINATION_PRODUCTFractional 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)
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-89 2. Has one large keloid scar or at least two similar but separate keloid scars 3. Keloid present for at least 1 year
Exclusion criteria
1. Currently pregnant 2. Currently breastfeeding 3. Have taken oral retinoids within 6 months of study initiation 4. Has had keloid treatment within 1 month of study initiation 5. Has active infection at treatment site 6. Has active malignancy 7. Presence of pedunculated keloid(s) or keloid(s) that are judged to be best treated with surgical excision first 8. Hypertrophic scars 9. Known hypersensitivity to TAC or 5-FU 10. Chronic systemic corticosteroid or immunosuppressive medication use 11. Has intolerance to anesthesia 12. Has known connective tissue disease 13. Has known infectious disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit | 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 | Baseline, Week 16 | The Hamilton scale consists of 4 items with a score range of 0 to 14, where 14 represents more severe scarring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Scar Measurement From Baseline to Final Visit | Baseline, Week 16 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age, Continuous | 36 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 12 / 19 | 12 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
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.
Time frame: Baseline, Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site A of Keloid Scar - 5-FU | Change in Modified Hamilton Score | -0.88 score on a scale | Standard Deviation 1.79 |
| Site B of Keloid Scar - TAC | Change in Modified Hamilton Score | -1.36 score on a scale | Standard Deviation 1.21 |
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.
Time frame: Baseline, Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site A of Keloid Scar - 5-FU | Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit | -20 score on a scale | Standard Deviation 8 |
| Site B of Keloid Scar - TAC | Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit | -20.6 score on a scale | Standard Deviation 13.1 |
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.
Time frame: Baseline, Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site A of Keloid Scar - 5-FU | Change in Scar Measurement From Baseline to Final Visit | -368.7 cm^3 | Standard Deviation 692.9 |
| Site B of Keloid Scar - TAC | Change in Scar Measurement From Baseline to Final Visit | -310.7 cm^3 | Standard Deviation 626.7 |