Trial Outcomes & Findings for Multiplex Laser vs. PDL (Pulsed Dye Laser ) in the Treatment of Surgical Scars (NCT NCT02472405)
NCT ID: NCT02472405
Last Updated: 2018-08-21
Results Overview
POSAS is a scale that contains the following parameters: pigmentation, vascularity, pliability, height, surface area, and patient input with regards to pain, itching, relief, stiffness, color and thickness. Both the patient and the observer are asked to give their Overall Opinion on the appearance of the scar. Again, a 10-point scale (ranging from 1 to 10) is used in which 10 corresponds to the worst imaginable scar.
COMPLETED
NA
18 participants
2 months
2018-08-21
Participant Flow
Participant milestones
| Measure |
595nm PDL - 595/1064nm Multiplex - Control
A third of each participant's scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). And the remaining third of the scar was left untreated for the duration of the study. The order of treatment was not randomized. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.
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|---|---|
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Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
595nm PDL - 595/1064nm Multiplex - Control
A third of each participant's scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). And the remaining third of the scar was left untreated for the duration of the study. The order of treatment was not randomized. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.
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|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
595nm PDL - 595/1064nm Multiplex - Control
n=18 Participants
A third of each participant's scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). And the remaining third of the scar was left untreated for the duration of the study. The order of treatment was not randomized. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: The measurement used for this outcome was completed 4 weeks post final intervention, only eight participants completed the study protocol, but only 6 participant's POSAS score was collected. Observer's score for the POSAS is not available. Only the score for the participants was reported.
POSAS is a scale that contains the following parameters: pigmentation, vascularity, pliability, height, surface area, and patient input with regards to pain, itching, relief, stiffness, color and thickness. Both the patient and the observer are asked to give their Overall Opinion on the appearance of the scar. Again, a 10-point scale (ranging from 1 to 10) is used in which 10 corresponds to the worst imaginable scar.
Outcome measures
| Measure |
595nm PDL
n=6 Participants
One third of the scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.
595nm PDL: One third of the scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week).
|
595/1064nm Multiplex Laser
n=6 Participants
One third of the scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.
595/1064nm Multiplex Laser: The multiplex cynergy laser was used for this study. A third of the scar was solely be treated with the 595nm PDL.
|
Control
n=6 Participants
One third of the scar was left untreated for the duration of the study. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.
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|---|---|---|---|
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POSAS (The Patient and Observer Scar Assessment Scale) Measure
|
2.5 Score
Standard Deviation 1.5
|
2.5 Score
Standard Deviation 1.5
|
2.5 Score
Standard Deviation 1.5
|
Adverse Events
595nm PDL - 595/1064nm Multiplex Laser - Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
595nm PDL - 595/1064nm Multiplex Laser - Control
n=18 participants at risk
A third of each participant's scar was treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). Another third of the scar was treated with 595nm PDL solely for 3 weeks (1 treatment session per week). The remaining third of the scar was left untreated for the duration of the study. A blinded observer evaluated each third of the scar 4 weeks after the last treatment session using the POSAS system.
595/1064nm Multiplex Laser: The multiplex cynergy laser will be used for this study. A third of the scar will solely be treated with the 595nm PDL.
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|---|---|
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Skin and subcutaneous tissue disorders
Minor bleeding and scabbing
|
5.6%
1/18 • Seven weeks.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
5.6%
1/18 • Seven weeks.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place