Trial Outcomes & Findings for Interventional Study to Evaluate the Appearance of Surgical Scars After Laser Therapy (NCT NCT02985151)
NCT ID: NCT02985151
Last Updated: 2023-06-06
Results Overview
Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the suface area of the scar after laser therapy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)
Results posted on
2023-06-06
Participant Flow
51 patients enrolled in the study. One subject withdrew from the study prior to treatment. A total of 50 subjects received treatment in the study. There were 10 subjects who crossed-over from low-energy treatment to high-energy treatment after completing the low-energy portion of the study.
Participant milestones
| Measure |
High Energy Treatment Group
Subjects in this group received one to two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser will administer energy at either a high-intensity setting or a low-intensity setting to subjects randomized into a particular treatment group. It will be operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
|---|---|---|
|
Original Randomization
STARTED
|
25
|
26
|
|
Original Randomization
COMPLETED
|
25
|
25
|
|
Original Randomization
NOT COMPLETED
|
0
|
1
|
|
Crossover From Low to High Energy
STARTED
|
0
|
10
|
|
Crossover From Low to High Energy
COMPLETED
|
0
|
10
|
|
Crossover From Low to High Energy
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
High Energy Treatment Group
Subjects in this group received one to two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser will administer energy at either a high-intensity setting or a low-intensity setting to subjects randomized into a particular treatment group. It will be operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
|---|---|---|
|
Original Randomization
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Interventional Study to Evaluate the Appearance of Surgical Scars After Laser Therapy
Baseline characteristics by cohort
| Measure |
High Energy Treatment Group
n=25 Participants
Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
n=26 Participants
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Baseline Scar Length
|
31.0 mm
STANDARD_DEVIATION 17.42809 • n=5 Participants
|
36.8 mm
STANDARD_DEVIATION 27.25163 • n=7 Participants
|
33.5044 mm
STANDARD_DEVIATION 22.13543 • n=5 Participants
|
|
Baseline Scar Width
|
10.7 mm
STANDARD_DEVIATION 10.25 • n=5 Participants
|
11.6 mm
STANDARD_DEVIATION 9.95 • n=7 Participants
|
11.08 mm
STANDARD_DEVIATION 10.05 • n=5 Participants
|
|
Baseline Scar Surface Area
|
2.7 cm^2
STANDARD_DEVIATION 2.37 • n=5 Participants
|
4.4 cm^2
STANDARD_DEVIATION 6.72 • n=7 Participants
|
3.41 cm^2
STANDARD_DEVIATION 4.74 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months (month 0-3 for original randomized group, month 6-9 for crossover group)Population: The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).
Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.
Outcome measures
| Measure |
High Energy Treatment Group
n=35 Participants
Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
n=25 Participants
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
|---|---|---|
|
Change in Vectra Measured Length V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group
|
0.10 mm
Standard Deviation 0.78
|
0.03 mm
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: 3 months (month 0-3 for original randomized group, month 6-9 for crossover group)Population: The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).
Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.
Outcome measures
| Measure |
High Energy Treatment Group
n=35 Participants
Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
n=25 Participants
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
|---|---|---|
|
In Person Blinded Observer POSAS Change V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group
|
-3.29 score on a scale
Standard Deviation 3.95
|
-3.30 score on a scale
Standard Deviation 3.76
|
PRIMARY outcome
Timeframe: 3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)Population: The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).
Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the width of the scar after laser therapy.
Outcome measures
| Measure |
High Energy Treatment Group
n=35 Participants
Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
n=25 Participants
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
|---|---|---|
|
Change in Vectra Measured Width V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group
|
0.06 mm
Standard Deviation 0.34
|
-0.08 mm
Standard Deviation 0.39
|
PRIMARY outcome
Timeframe: 3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)Population: The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).
Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the surface area of the scar after laser therapy.
Outcome measures
| Measure |
High Energy Treatment Group
n=35 Participants
Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
n=25 Participants
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
|---|---|---|
|
Change in Vectra Measured Surface Area V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group
|
0.01 cm^2
Standard Deviation 0.11
|
-0.04 cm^2
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: 6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)Population: The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).
Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.
Outcome measures
| Measure |
High Energy Treatment Group
n=35 Participants
Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
n=25 Participants
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
|---|---|---|
|
Change in Vectra Measured Length V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group
|
0.42 mm
Standard Deviation 1.18
|
-0.23 mm
Standard Deviation 0.96
|
PRIMARY outcome
Timeframe: 6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)Population: The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).
Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the width of the scar after laser therapy.
Outcome measures
| Measure |
High Energy Treatment Group
n=35 Participants
Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
n=25 Participants
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
|---|---|---|
|
Change in Vectra Measured Width V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group
|
0.19 mm
Standard Deviation 0.83
|
-1.37 mm
Standard Deviation 4.62
|
PRIMARY outcome
Timeframe: 6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)Population: The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).
Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the suface area of the scar after laser therapy.
Outcome measures
| Measure |
High Energy Treatment Group
n=35 Participants
Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
n=25 Participants
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
|---|---|---|
|
Change in Vectra Measured Surface Area V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group
|
0.08 cm^2
Standard Deviation 0.18
|
-0.05 cm^2
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: 6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)Population: The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).
Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.
Outcome measures
| Measure |
High Energy Treatment Group
n=35 Participants
Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
n=25 Participants
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
|---|---|---|
|
In-person Blinded Observer Change POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group
|
-4.95 score on a scale
Standard Deviation 2.98
|
-5.16 score on a scale
Standard Deviation 5.29
|
PRIMARY outcome
Timeframe: 3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)Population: The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).
Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by the blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.
Outcome measures
| Measure |
High Energy Treatment Group
n=35 Participants
Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
n=25 Participants
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
|---|---|---|
|
Change in Blinded Photo Observer Score POSAS V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group
|
-2.36 score on a scale
Standard Deviation 3.51
|
-2.73 score on a scale
Standard Deviation 2.81
|
PRIMARY outcome
Timeframe: 6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.
Outcome measures
| Measure |
High Energy Treatment Group
n=35 Participants
Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
n=25 Participants
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
|---|---|---|
|
Change in Blinded Photo Observer Score on POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group
|
-4.18 score on a scale
Standard Deviation 4.38
|
-4.28 score on a scale
Standard Deviation 3.40
|
SECONDARY outcome
Timeframe: V1 (month 0) and V2 (month 3) for the original group; visit 3 (month 6) and visit 4 (month 9) for crossover groupPopulation: The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).
Participants will be given a diary to record the severity and duration of symptoms for the day of treatment and then daily for seven days after each laser treatment: redness, scaling/flaking, pustules, swelling, pain, itching, burning, color changes (darkening and/or lightning), infection, and any other adverse events that arise following treatment. Subjects score each of the symptom severity on a scale of 0-4 (0=none, 1= mild, 2= moderate, 3= intense, 4= intolerable). The average weekly score for each group is reported below.
Outcome measures
| Measure |
High Energy Treatment Group
n=35 Participants
Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
n=25 Participants
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
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|---|---|---|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Redness After Visit 1
|
1.91 score on a scale
Standard Deviation 0.73
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1.98 score on a scale
Standard Deviation 0.63
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Scaling After Visit 1
|
0.58 score on a scale
Standard Deviation 0.62
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0.70 score on a scale
Standard Deviation 0.53
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Pustules After Visit 1
|
0.41 score on a scale
Standard Deviation 0.67
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0.29 score on a scale
Standard Deviation 0.48
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Swelling After Visit 1
|
1.03 score on a scale
Standard Deviation 0.90
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0.99 score on a scale
Standard Deviation 0.92
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Pain After Visit 1
|
0.45 score on a scale
Standard Deviation 0.54
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0.62 score on a scale
Standard Deviation 0.60
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Itch After Visit 1
|
0.63 score on a scale
Standard Deviation 0.59
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0.64 score on a scale
Standard Deviation 0.73
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Burn After Visit 1
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0.36 score on a scale
Standard Deviation 0.44
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0.59 score on a scale
Standard Deviation 0.44
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Color After Visit 1
|
0.69 score on a scale
Standard Deviation 0.90
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0.95 score on a scale
Standard Deviation 0.96
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Infection After Visit 1
|
0.06 score on a scale
Standard Deviation 0.19
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0.0 score on a scale
Standard Deviation 0.0
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Redness After Visit 2
|
1.78 score on a scale
Standard Deviation 0.77
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2.00 score on a scale
Standard Deviation 0.62
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Scaling After Visit 2
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0.83 score on a scale
Standard Deviation 0.70
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0.95 score on a scale
Standard Deviation 0.64
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Pustules After Visit 2
|
0.38 score on a scale
Standard Deviation 0.67
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0.58 score on a scale
Standard Deviation 0.75
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Swelling After Visit 2
|
1.17 score on a scale
Standard Deviation 0.90
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1.04 score on a scale
Standard Deviation 0.89
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Pain After Visit 2
|
0.58 score on a scale
Standard Deviation 0.74
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0.66 score on a scale
Standard Deviation 0.74
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Itch After Visit 2
|
0.56 score on a scale
Standard Deviation 0.50
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1.23 score on a scale
Standard Deviation 1.02
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Burn After Visit 2
|
0.49 score on a scale
Standard Deviation 0.66
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0.65 score on a scale
Standard Deviation 0.68
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Color After Visit 2
|
0.96 score on a scale
Standard Deviation 0.81
|
0.64 score on a scale
Standard Deviation 0.96
|
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Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
Patient Diary Infection After Visit 2
|
0.01 score on a scale
Standard Deviation 0.06
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0.0 score on a scale
Standard Deviation 0.0
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Adverse Events
High Energy Treatment Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Low Energy Placebo Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Energy Treatment Group
n=35 participants at risk
Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
Low Energy Placebo Group
n=26 participants at risk
Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.
|
|---|---|---|
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Musculoskeletal and connective tissue disorders
Fracture
|
5.7%
2/35 • Number of events 2 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
11.5%
3/26 • Number of events 3 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
|
Infections and infestations
Infection
|
8.6%
3/35 • Number of events 3 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
3.8%
1/26 • Number of events 1 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
|
Vascular disorders
Lymphedema
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
0.00%
0/26 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
|
Nervous system disorders
Concussion
|
0.00%
0/35 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
3.8%
1/26 • Number of events 1 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/35 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
3.8%
1/26 • Number of events 1 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/35 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
3.8%
1/26 • Number of events 1 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma of the Skin
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
0.00%
0/26 • Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
|
Additional Information
Research Manager/Coordinator
Dermatology SLUCare Physician Group
Phone: 314 977-1794
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place