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

Primary Purpose

Keloid Scar

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil
Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid Scar

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Site A of keloid scar

Site B of keloid scar

Arm Description

One half of keloid scarring on a single subject

One half of keloid scarring on a single subject

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
January 25, 2021
Last Updated
June 15, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04786210
Brief Title
Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid
Official Title
A Prospective Triple-Blinded Single-Center Study of Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid Treatment for Keloids
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2021 (Actual)
Primary Completion Date
December 16, 2022 (Actual)
Study Completion Date
December 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid Scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Site A of keloid scar
Arm Type
Experimental
Arm Description
One half of keloid scarring on a single subject
Arm Title
Site B of keloid scar
Arm Type
Experimental
Arm Description
One half of keloid scarring on a single subject
Intervention Type
Combination Product
Intervention Name(s)
Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil
Intervention Description
Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil solution to one half of the scar (4 treatments)
Intervention Type
Combination Product
Intervention Name(s)
Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in Patient and Observer Scar Assessment Scale (POSAS) Score from Baseline to Final Visit
Description
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
Title
Modified Hamilton Score at Final Study Visit
Description
The Hamilton scale consists of 4 items with a score range of 0 to 14, where 14 represents more severe scarring.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Scar Measurement at Baseline of Keloid Site Treated with Laser-Assisted 5-FU
Description
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
Title
Scar Measurement of Keloid Site Treated with Laser-Assisted 5-FU at Final Visit
Description
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
Week 16
Title
Scar Measurement at Baseline of Keloid Site Treated with Laser-Assisted TAC
Description
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
Title
Scar Measurement of Keloid Site Treated with Laser-Assisted TAC at Final Visit
Description
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
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nayoung Lee, MD
Organizational Affiliation
NYU Langone
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
Requests should be directed to nayoung.lee@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

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

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