Trial Outcomes & Findings for Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars (NCT NCT01789346)
NCT ID: NCT01789346
Last Updated: 2023-02-21
Results Overview
Improvement in surgical scar of 532 nm KTP and 595 nm PDL treatment arms at 12 weeks post-final treatment (compared to baseline) as assessed by blinded independent reviewers Physician's Global Assessment (min=0; max=3) Higher scores mean better outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
12-weeks post-final laser treatment
Results posted on
2023-02-21
Participant Flow
Unit of analysis: Halves or single scars treated
Participant milestones
| Measure |
All Study Participants
Patients with matched bilateral erythematous surgical scars or a single linear erythematous scar measuring longer than 5 cm were enrolled in the study. Single scars were divided into equal halves, with each half randomized to receive treatments with either a 532-nm KTP laser (Excel V; Brisbane, CA) or a 595-nm PDL (Cynergy; Cynosure Inc., Chelmsford, MA) at equivalent laser parameters. Bilateral matched scars were similarly randomized to receive 532-nm KTP or 595-nm PDL treatments.
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|---|---|
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Overall Study
STARTED
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20 40
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Overall Study
Treatment With 532 nm KTP Laser
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20 20
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Overall Study
Treatment With 595 nm PDL Laser
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20 20
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Overall Study
COMPLETED
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18 36
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Overall Study
NOT COMPLETED
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2 4
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Subjects
n=20 Participants
All subjects treated with Cutera ExcelV 532nm KTP laser or Cynosure Cynergy 595nm pulsed-dye laser
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|---|---|
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Age, Continuous
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49.4 years
STANDARD_DEVIATION 11.7 • n=20 Participants
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Sex: Female, Male
Female
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19 Participants
n=20 Participants
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Sex: Female, Male
Male
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1 Participants
n=20 Participants
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Region of Enrollment
United States
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20 participants
n=20 Participants
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PRIMARY outcome
Timeframe: 12-weeks post-final laser treatmentImprovement in surgical scar of 532 nm KTP and 595 nm PDL treatment arms at 12 weeks post-final treatment (compared to baseline) as assessed by blinded independent reviewers Physician's Global Assessment (min=0; max=3) Higher scores mean better outcome
Outcome measures
| Measure |
532nm KTP Laser
n=18 Halves or single scars treated
Cutera ExcelV 532nm KTP laser
532nm potassium titanyl phosphate (KTP) laser
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595nm PDL
n=18 Halves or single scars treated
Cynosure Cynergy 595nm pulsed-dye laser
595nm pulsed-dye laser (PDL)
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|---|---|---|
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Improvement in Surgical Scar of Treatment (532nm KTP Laser) and Active Control (595nm PDL) Treatment Arms.
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2.0 score on a scale
Interval 1.0 to 2.5
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1.5 score on a scale
Interval 0.0 to 2.0
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Adverse Events
532nm KTP Laser
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
595nm PDL
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
532nm KTP Laser
n=19 participants at risk
Cutera ExcelV 532nm KTP laser
532nm potassium titanyl phosphate (KTP) laser
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595nm PDL
n=19 participants at risk
Cynosure Cynergy 595nm pulsed-dye laser
595nm pulsed-dye laser (PDL)
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|---|---|---|
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Skin and subcutaneous tissue disorders
Erythema
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47.4%
9/19 • Adverse events were collected from the time of first laser treatment through completion of the study for all subjects (24 weeks)
Systematic assessment occurred through regular investigator assessments during study visits. Between visits, participants were also encouraged to contact the site to report any adverse events that occurred as applicable.
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36.8%
7/19 • Adverse events were collected from the time of first laser treatment through completion of the study for all subjects (24 weeks)
Systematic assessment occurred through regular investigator assessments during study visits. Between visits, participants were also encouraged to contact the site to report any adverse events that occurred as applicable.
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Skin and subcutaneous tissue disorders
Edema
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10.5%
2/19 • Adverse events were collected from the time of first laser treatment through completion of the study for all subjects (24 weeks)
Systematic assessment occurred through regular investigator assessments during study visits. Between visits, participants were also encouraged to contact the site to report any adverse events that occurred as applicable.
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10.5%
2/19 • Adverse events were collected from the time of first laser treatment through completion of the study for all subjects (24 weeks)
Systematic assessment occurred through regular investigator assessments during study visits. Between visits, participants were also encouraged to contact the site to report any adverse events that occurred as applicable.
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Skin and subcutaneous tissue disorders
Purpura
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15.8%
3/19 • Adverse events were collected from the time of first laser treatment through completion of the study for all subjects (24 weeks)
Systematic assessment occurred through regular investigator assessments during study visits. Between visits, participants were also encouraged to contact the site to report any adverse events that occurred as applicable.
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5.3%
1/19 • Adverse events were collected from the time of first laser treatment through completion of the study for all subjects (24 weeks)
Systematic assessment occurred through regular investigator assessments during study visits. Between visits, participants were also encouraged to contact the site to report any adverse events that occurred as applicable.
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Skin and subcutaneous tissue disorders
Crusting
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10.5%
2/19 • Adverse events were collected from the time of first laser treatment through completion of the study for all subjects (24 weeks)
Systematic assessment occurred through regular investigator assessments during study visits. Between visits, participants were also encouraged to contact the site to report any adverse events that occurred as applicable.
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0.00%
0/19 • Adverse events were collected from the time of first laser treatment through completion of the study for all subjects (24 weeks)
Systematic assessment occurred through regular investigator assessments during study visits. Between visits, participants were also encouraged to contact the site to report any adverse events that occurred as applicable.
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Skin and subcutaneous tissue disorders
Burning Sensation
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5.3%
1/19 • Adverse events were collected from the time of first laser treatment through completion of the study for all subjects (24 weeks)
Systematic assessment occurred through regular investigator assessments during study visits. Between visits, participants were also encouraged to contact the site to report any adverse events that occurred as applicable.
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5.3%
1/19 • Adverse events were collected from the time of first laser treatment through completion of the study for all subjects (24 weeks)
Systematic assessment occurred through regular investigator assessments during study visits. Between visits, participants were also encouraged to contact the site to report any adverse events that occurred as applicable.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place