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

NYU Langone Health

Status and phase: Completed; Phase 4

Conditions: Keloid Scar

Treatments: Combination Product: Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide; Combination Product: Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT04786210

20-01172

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Site A of keloid scar

Experimental group

Description:

One half of keloid scarring on a single subject

Treatment:

Combination Product: Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil

Site B of keloid scar

Experimental group

Description:

One half of keloid scarring on a single subject

Treatment:

Combination Product: Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide