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

Keloid Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04786210
• Other study ID #: 20-01172
• Status: Completed
• Phase: Phase 4
• Start date: January 30, 2021
• Est. completion date: December 16, 2022

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Keloid
• Keloid Scar

Intervention

Combination Product:
• 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)
• 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)

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, Week 16
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.	Baseline, Week 16
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.	Baseline, Week 16