Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid

Study Overview
=================
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.

Official Title
-----------------
A Prospective Triple-Blinded Single-Center Study of Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid Treatment for Keloids

Conditions
-----------------
Keloid Scar

Intervention / Treatment
-----------------
* Combination Product: Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil
* Combination Product: Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age 18-89 Has one large keloid scar or at least two similar but separate keloid scars Keloid present for at least 1 year Exclusion Criteria 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Site A of keloid scar<br>One half of keloid scarring on a single subject | Combination Product: Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil<br>* Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil solution to one half of the scar (4 treatments)<br>|
| Experimental: Site B of keloid scar<br>One half of keloid scarring on a single subject | Combination Product: Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 
| Modified Hamilton Score at Final Study Visit | The Hamilton scale consists of 4 items with a score range of 0 to 14, where 14 represents more severe scarring. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar Measurement at Baseline of Keloid Site Treated with Laser-Assisted 5-FU | 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 | 
| Scar Measurement of Keloid Site Treated with Laser-Assisted 5-FU at 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. | Week 16 | 
| Scar Measurement at Baseline of Keloid Site Treated with Laser-Assisted TAC | 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 | 
| Scar Measurement of Keloid Site Treated with Laser-Assisted TAC at 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. | Week 16 |