Trial Outcomes & Findings for Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid (NCT NCT04786210)
NCT ID: NCT04786210
Last Updated: 2024-03-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2024-03-26
Participant Flow
Unit of analysis: halves of keloid scarring
Participant milestones
| Measure |
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).
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|---|---|
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Overall Study
STARTED
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19 38
|
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Overall Study
Received 5-fluorouracil (5-FU)
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19 19
|
|
Overall Study
Received Triamcinolone Acetonide
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19 19
|
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Overall Study
COMPLETED
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13 26
|
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Overall Study
NOT COMPLETED
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6 12
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Reasons for withdrawal
| Measure |
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).
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|---|---|
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Overall Study
Lost to Follow-up
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2
|
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Overall Study
Withdrawal by Subject
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4
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Baseline Characteristics
Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=15 Participants
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).
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|---|---|
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Age, Continuous
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36 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
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|
Sex: Female, Male
Male
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6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=93 Participants
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|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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15 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
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5 Participants
n=93 Participants
|
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Race (NIH/OMB)
White
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3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
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Region of Enrollment
United States
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15 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16POSAS 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.
Outcome measures
| Measure |
Site A of Keloid Scar - 5-FU
n=13 Keloid scar
One half of keloid scarring on a single subject
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)
|
Site B of Keloid Scar - TAC
n=13 Keloid scar
One half of keloid scarring on a single subject
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)
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|---|---|---|
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Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit
|
-20 score on a scale
Standard Deviation 8
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-20.6 score on a scale
Standard Deviation 13.1
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PRIMARY outcome
Timeframe: Baseline, Week 16The Hamilton scale consists of 4 items with a score range of 0 to 14, where 14 represents more severe scarring.
Outcome measures
| Measure |
Site A of Keloid Scar - 5-FU
n=14 Keloid scar
One half of keloid scarring on a single subject
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)
|
Site B of Keloid Scar - TAC
n=14 Keloid scar
One half of keloid scarring on a single subject
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)
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|---|---|---|
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Change in Modified Hamilton Score
|
-0.88 score on a scale
Standard Deviation 1.79
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-1.36 score on a scale
Standard Deviation 1.21
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SECONDARY outcome
Timeframe: Baseline, Week 16Scar 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.
Outcome measures
| Measure |
Site A of Keloid Scar - 5-FU
n=13 Keloid scar
One half of keloid scarring on a single subject
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)
|
Site B of Keloid Scar - TAC
n=13 Keloid scar
One half of keloid scarring on a single subject
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)
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|---|---|---|
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Change in Scar Measurement From Baseline to Final Visit
|
-368.7 cm^3
Standard Deviation 692.9
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-310.7 cm^3
Standard Deviation 626.7
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Adverse Events
Site A of Keloid Scar - 5-FU
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Site B of Keloid Scar - TAC
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Site A of Keloid Scar - 5-FU
n=19 participants at risk
One half of keloid scarring on a single subject
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)
|
Site B of Keloid Scar - TAC
n=19 participants at risk
One half of keloid scarring on a single subject
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)
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|---|---|---|
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Skin and subcutaneous tissue disorders
Bleeding at site
|
5.3%
1/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
0.00%
0/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
|
Skin and subcutaneous tissue disorders
Bruising at site
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5.3%
1/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
5.3%
1/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
|
Skin and subcutaneous tissue disorders
Swelling/edema at site
|
15.8%
3/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
5.3%
1/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
|
Skin and subcutaneous tissue disorders
Burning at site
|
5.3%
1/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
5.3%
1/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
|
Skin and subcutaneous tissue disorders
Erythema of site
|
5.3%
1/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
5.3%
1/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation of site
|
47.4%
9/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
15.8%
3/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation of site
|
10.5%
2/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
0.00%
0/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
|
Skin and subcutaneous tissue disorders
Itching at site
|
42.1%
8/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
31.6%
6/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
|
Skin and subcutaneous tissue disorders
Pain at site
|
21.1%
4/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
21.1%
4/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
|
Skin and subcutaneous tissue disorders
Spreading/growth of scar
|
5.3%
1/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
0.00%
0/19 • Through study completion, on average 1 year.
Systematic - At each visit subsequent to visit 1, a standard questionnaire of side effects was administered to participants (yielding 4 assessments for side effects per participant). All-cause mortality was not assessed in this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place