Trial Outcomes & Findings for Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention (NCT NCT03795116)
NCT ID: NCT03795116
Last Updated: 2022-06-01
Results Overview
The ElastiMeter, a non-invasive indentation instrument, will be used to evaluate skin elasticity (i.e., skin stiffness) of the LED-RL-treated scar versus the untreated scar. Skin elasticity is measured in Newtons/meters (N/m).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
1 month, 3 months, 6 months
Results posted on
2022-06-01
Participant Flow
30 participants were included in the study. This was a split-face study in which each patient received LED-RL phototherapy (i.e. low, medium, or high dose) on one preauricular incision site and mock phototherapy on the other preauricular incision site.
Unit of analysis: Incision Sites
Participant milestones
| Measure |
LED-RL Phototherapy Group 1
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes
|
Mock Irradiation Group 1
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 1: Received mock phototherapy for 30 minutes.
|
LED-RL Phototherapy Group 2
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes
|
Mock Irradiation Group 2
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 2: Received mock phototherapy for 60 minutes.
|
LED-RL Phototherapy Group 3
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes
|
Mock Irradiation Group 3
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 3: Received mock phototherapy for 90 minutes.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10 10
|
10 10
|
10 10
|
10 10
|
10 10
|
10 10
|
|
Overall Study
COMPLETED
|
6 6
|
6 6
|
9 9
|
9 9
|
9 9
|
9 9
|
|
Overall Study
NOT COMPLETED
|
4 4
|
4 4
|
1 1
|
1 1
|
1 1
|
1 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention
Baseline characteristics by cohort
| Measure |
All Participants Group 1
n=10 Participants
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Group 1 participants received Low dose LED-RL (160 J/cm2) for 30 minutes on one incision site and mock phototherapy for 30 minutes on the other incision site.
|
All Participants Group 2
n=10 Participants
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Group 2 participants received medium dose LED-RL (320 J/cm2) for 60 minutes on one incision site and mock phototherapy for 60 minutes on the other incision site.
|
All Participants Group 3
n=10 Participants
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Group 3 participants received high dose LED-RL (480 J/cm2) for 90 minutes on one incision site and mock phototherapy for 90 minutes on the other incision site.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
54.1 years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White non-hispanic
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White hispanic
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Two or more races
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 month, 3 months, 6 monthsPopulation: Collected data were not considered valid due to an equipment malfunction.
The ElastiMeter, a non-invasive indentation instrument, will be used to evaluate skin elasticity (i.e., skin stiffness) of the LED-RL-treated scar versus the untreated scar. Skin elasticity is measured in Newtons/meters (N/m).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).Population: In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.
The SkinFibroMeter, a non-invasive indentation instrument, will be used to evaluate the induration of the skin and subcutaneous tissue (i.e., hardness) of the LED-RL-treated scar versus the untreated scar. Skin induration is measured in Newtons (N).
Outcome measures
| Measure |
Mock Irradiation Group 3
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 3: Received mock phototherapy for 90 minutes.
|
LED-RL Phototherapy
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.
|
Mock Irradiation
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.
|
LED-RL Phototherapy Group 2
n=10 Incision Sites
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes
|
Mock Irradiation Group 2
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 2: Received mock phototherapy for 60 minutes.
|
LED-RL Phototherapy Group 3
n=10 Incision Sites
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes
|
|---|---|---|---|---|---|---|
|
Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline
Baseline
|
.07 Newton
Interval 0.02 to 0.08
|
.08 Newton
Interval 0.04 to 0.14
|
.05 Newton
Interval 0.02 to 0.08
|
.09 Newton
Interval 0.03 to 0.13
|
.06 Newton
Interval 0.04 to 0.08
|
.06 Newton
Interval 0.04 to 0.07
|
|
Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline
1 month
|
.04 Newton
Interval 0.02 to 0.04
|
.05 Newton
Interval 0.04 to 0.08
|
.04 Newton
Interval 0.03 to 0.08
|
.06 Newton
Interval 0.04 to 0.08
|
.05 Newton
Interval 0.03 to 0.12
|
.05 Newton
Interval 0.03 to 0.08
|
|
Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline
3 months
|
.06 Newton
Interval 0.04 to 0.08
|
.03 Newton
Interval 0.03 to 0.06
|
.04 Newton
Interval 0.02 to 0.05
|
.04 Newton
Interval 0.03 to 0.07
|
.04 Newton
Interval 0.04 to 0.07
|
.05 Newton
Interval 0.04 to 0.06
|
|
Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline
6 months
|
.02 Newton
Interval 0.02 to 0.03
|
.03 Newton
Interval 0.02 to 0.03
|
.03 Newton
Interval 0.02 to 0.03
|
.02 Newton
Interval 0.02 to 0.03
|
.03 Newton
Interval 0.03 to 0.03
|
.03 Newton
Interval 0.02 to 0.03
|
SECONDARY outcome
Timeframe: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).Population: In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.
The scale consists of six items rated from 1 to 10, where 1 is "normal skin" and 10 is the "worst imaginable scar". The observer (i.e., investigator) evaluates scar vascularity, pigmentation, thickness, relief, pliability, and surface area. The scores of each of the six items are summed for a total score (range 6 to 60).
Outcome measures
| Measure |
Mock Irradiation Group 3
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 3: Received mock phototherapy for 90 minutes.
|
LED-RL Phototherapy
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.
|
Mock Irradiation
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.
|
LED-RL Phototherapy Group 2
n=10 Incision Sites
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes
|
Mock Irradiation Group 2
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 2: Received mock phototherapy for 60 minutes.
|
LED-RL Phototherapy Group 3
n=10 Incision Sites
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes
|
|---|---|---|---|---|---|---|
|
Observer Scar Assessment Scale
Baseline
|
16.5 score on a scale
Interval 15.0 to 20.0
|
16.5 score on a scale
Interval 14.0 to 20.0
|
16.5 score on a scale
Interval 15.0 to 21.0
|
19.0 score on a scale
Interval 16.0 to 21.0
|
14.0 score on a scale
Interval 13.0 to 17.0
|
18.0 score on a scale
Interval 16.0 to 19.0
|
|
Observer Scar Assessment Scale
1 month
|
13.0 score on a scale
Interval 12.0 to 15.0
|
17.0 score on a scale
Interval 15.0 to 18.0
|
17.0 score on a scale
Interval 14.0 to 19.0
|
13.0 score on a scale
Interval 11.0 to 16.0
|
17.5 score on a scale
Interval 11.0 to 19.0
|
19.0 score on a scale
Interval 17.0 to 21.0
|
|
Observer Scar Assessment Scale
3 months
|
13.0 score on a scale
Interval 12.0 to 14.0
|
12.5 score on a scale
Interval 11.5 to 17.0
|
15.0 score on a scale
Interval 14.0 to 16.0
|
12.0 score on a scale
Interval 11.0 to 18.0
|
14.0 score on a scale
Interval 9.0 to 18.0
|
15.0 score on a scale
Interval 12.0 to 19.0
|
|
Observer Scar Assessment Scale
6 months
|
12.0 score on a scale
Interval 8.0 to 19.0
|
9.0 score on a scale
Interval 8.0 to 18.0
|
12.5 score on a scale
Interval 11.0 to 14.0
|
8.0 score on a scale
Interval 8.0 to 20.0
|
14.0 score on a scale
Interval 12.0 to 16.0
|
13.0 score on a scale
Interval 10.0 to 15.0
|
SECONDARY outcome
Timeframe: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).Population: Data were not collected for this outcome measure.
The scar images will be rated by two independent, blinded dermatologists using a VAS. The VAS is presented as a 10 cm horizontal line, where the extreme ends of 0 indicates "normal skin" and 10 corresponds to the "worst possible scar," for each of the following scar attributes: pigmentation, vascularity, observer comfort, contour, and overall severity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).Population: In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.
A non-invasive, handheld diffuse reflectance probe will be used to measure collagen concentration in the dermis at each incision site. The scale ranges from 10 to 99 and the collagen measurement corresponds to the half of the optical scattering coefficient of the dermis.
Outcome measures
| Measure |
Mock Irradiation Group 3
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 3: Received mock phototherapy for 90 minutes.
|
LED-RL Phototherapy
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.
|
Mock Irradiation
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.
|
LED-RL Phototherapy Group 2
n=10 Incision Sites
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes
|
Mock Irradiation Group 2
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 2: Received mock phototherapy for 60 minutes.
|
LED-RL Phototherapy Group 3
n=10 Incision Sites
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes
|
|---|---|---|---|---|---|---|
|
Dermal Collagen Concentration
Baseline
|
52.5 arbitrary units
Interval 46.0 to 62.0
|
48.7 arbitrary units
Interval 41.0 to 59.5
|
52.0 arbitrary units
Interval 37.0 to 62.6
|
51.0 arbitrary units
Interval 34.0 to 59.0
|
50.5 arbitrary units
Interval 42.0 to 62.0
|
47.7 arbitrary units
Interval 39.3 to 62.0
|
|
Dermal Collagen Concentration
1 month
|
57.0 arbitrary units
Interval 48.3 to 60.3
|
60.3 arbitrary units
Interval 50.0 to 62.0
|
47.0 arbitrary units
Interval 29.3 to 56.3
|
50.7 arbitrary units
Interval 44.7 to 58.0
|
55.2 arbitrary units
Interval 43.7 to 60.0
|
52.7 arbitrary units
Interval 42.3 to 60.7
|
|
Dermal Collagen Concentration
3 months
|
58.7 arbitrary units
Interval 55.6 to 62.0
|
57.5 arbitrary units
Interval 47.8 to 60.3
|
57.4 arbitrary units
Interval 55.5 to 61.5
|
58.3 arbitrary units
Interval 55.0 to 60.7
|
57.3 arbitrary units
Interval 54.7 to 58.0
|
58.7 arbitrary units
Interval 48.0 to 59.6
|
|
Dermal Collagen Concentration
6 months
|
59.3 arbitrary units
Interval 56.7 to 61.3
|
57.0 arbitrary units
Interval 55.3 to 58.7
|
56.5 arbitrary units
Interval 53.0 to 60.3
|
60.0 arbitrary units
Interval 56.0 to 61.7
|
61.0 arbitrary units
Interval 54.7 to 61.3
|
56.7 arbitrary units
Interval 50.3 to 57.0
|
SECONDARY outcome
Timeframe: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).Population: In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.
A non-invasive, handheld diffuse reflectance probe will be used to measure water concentration in the dermis at each incision site. Infrared light is emitted at different wavelengths to retrieve the scattering and the absorption coefficients of the dermis. The more water, the less reflectance. Concentration ranges from 40% to 85%.
Outcome measures
| Measure |
Mock Irradiation Group 3
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 3: Received mock phototherapy for 90 minutes.
|
LED-RL Phototherapy
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.
|
Mock Irradiation
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.
|
LED-RL Phototherapy Group 2
n=10 Incision Sites
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes
|
Mock Irradiation Group 2
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 2: Received mock phototherapy for 60 minutes.
|
LED-RL Phototherapy Group 3
n=10 Incision Sites
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes
|
|---|---|---|---|---|---|---|
|
Dermal Water Concentration
Baseline
|
66.2 percentage
Interval 63.0 to 68.0
|
63.0 percentage
Interval 60.0 to 64.3
|
65.3 percentage
Interval 62.3 to 66.0
|
60.7 percentage
Interval 58.7 to 62.0
|
62.7 percentage
Interval 60.0 to 66.0
|
63.2 percentage
Interval 62.0 to 67.7
|
|
Dermal Water Concentration
1 month
|
64.0 percentage
Interval 60.0 to 65.0
|
64.0 percentage
Interval 62.0 to 65.0
|
62.3 percentage
Interval 61.3 to 63.3
|
60.2 percentage
Interval 58.3 to 61.7
|
62.3 percentage
Interval 58.3 to 63.3
|
60.6 percentage
Interval 58.7 to 62.7
|
|
Dermal Water Concentration
3 months
|
62.0 percentage
Interval 57.0 to 67.6
|
63.0 percentage
Interval 59.7 to 67.8
|
61.4 percentage
Interval 59.0 to 67.3
|
63.0 percentage
Interval 59.7 to 66.3
|
60.7 percentage
Interval 59.3 to 62.3
|
61.7 percentage
Interval 60.6 to 63.3
|
|
Dermal Water Concentration
6 months
|
64.0 percentage
Interval 61.3 to 64.7
|
62.5 percentage
Interval 59.0 to 64.3
|
61.2 percentage
Interval 59.7 to 64.0
|
63.7 percentage
Interval 62.3 to 68.3
|
63.0 percentage
Interval 62.7 to 64.7
|
62.0 percentage
Interval 61.3 to 62.3
|
SECONDARY outcome
Timeframe: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).Population: Data were not collected for this outcome measure.
A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of pigmentation at each incision site.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).Population: Data were not collected for this outcome measure.
A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of vascularity at each incision site.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).Population: Data were not collected for this outcome measure.
A 3D digital imaging system will be used to construct 3D images of the scars for skin profilometry analyses, including quantitative measurements of tissue volume at each incision site.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Skin specimens will be obtained via optional 2 mm punch biopsy on post-operative day 0 (prior to surgery) and post-operative day 30 (first follow-up visit after completion of LED-RL treatment).Population: Biopsy was optional. This outcome measure was not performed for any subjects.
The histological changes that occur in vivo in response to LED-RL phototherapy will be evaluated by examination of pre- and post-treated skin tissue. Skin specimens will be obtained via optional 2 mm punch biopsy and stained for collagen fibers.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first LED-RL and mock phototherapy treatment session on post-operative day 5 until final follow-up visit on post-operative day 180 (6 month follow-up).Population: This was a split-face study including 30 participants. Each participant received LED-RL phototherapy (i.e. low, medium, or high dose) on one preauricular incision site and mock phototherapy on the other preauricular incision site.
Subjects will be provided with a daily diary to record any adverse events experienced during the three-week intervention period. Treatment sessions will be monitored closely for the occurrence of any safety issues or adverse events, as reported by the subject or observed by the clinical research team. At each follow up visit, patients will be asked about adverse effects.
Outcome measures
| Measure |
Mock Irradiation Group 3
n=10 Participants
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 3: Received mock phototherapy for 90 minutes.
|
LED-RL Phototherapy
n=10 Participants
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.
|
Mock Irradiation
n=10 Participants
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.
|
LED-RL Phototherapy Group 2
n=10 Participants
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes
|
Mock Irradiation Group 2
n=10 Participants
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 2: Received mock phototherapy for 60 minutes.
|
LED-RL Phototherapy Group 3
n=10 Participants
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes
|
|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events in Each Treatment Group
localized bulla
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Adverse Events in Each Treatment Group
localized facial swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Adverse Events in Each Treatment Group
no adverse events
|
10 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).Population: In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.
The scale consists of six items rated from 1 to 10, where 1 is "normal skin" and 10 is the "worst imaginable scar". The patient assesses pain, itching, color, stiffness, thickness, and irregularity. The scores of each of the six items are summed for a total score (range 6 to 60).
Outcome measures
| Measure |
Mock Irradiation Group 3
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 3: Received mock phototherapy for 90 minutes.
|
LED-RL Phototherapy
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.
|
Mock Irradiation
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.
|
LED-RL Phototherapy Group 2
n=10 Incision Sites
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes
|
Mock Irradiation Group 2
n=10 Incision Sites
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 2: Received mock phototherapy for 60 minutes.
|
LED-RL Phototherapy Group 3
n=10 Incision Sites
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes
|
|---|---|---|---|---|---|---|
|
Patient Scar Assessment Scale
6 months
|
17.0 score on a scale
Interval 11.0 to 26.0
|
12.0 score on a scale
Interval 7.0 to 17.0
|
10.5 score on a scale
Interval 10.0 to 12.0
|
23.0 score on a scale
Interval 12.0 to 28.0
|
18.0 score on a scale
Interval 16.0 to 24.0
|
13.0 score on a scale
Interval 10.0 to 25.0
|
|
Patient Scar Assessment Scale
Baseline
|
28.5 score on a scale
Interval 24.0 to 48.0
|
36.0 score on a scale
Interval 27.0 to 42.0
|
37.0 score on a scale
Interval 24.0 to 41.0
|
32.0 score on a scale
Interval 23.0 to 34.0
|
30.5 score on a scale
Interval 27.0 to 32.0
|
26.5 score on a scale
Interval 21.0 to 33.0
|
|
Patient Scar Assessment Scale
1 month
|
26.0 score on a scale
Interval 13.0 to 37.0
|
25.0 score on a scale
Interval 21.0 to 34.0
|
25.0 score on a scale
Interval 19.0 to 34.0
|
24.0 score on a scale
Interval 19.0 to 29.0
|
23.5 score on a scale
Interval 18.0 to 30.0
|
17.0 score on a scale
Interval 13.0 to 37.0
|
|
Patient Scar Assessment Scale
3 months
|
20.0 score on a scale
Interval 12.0 to 26.0
|
12.5 score on a scale
Interval 12.0 to 18.0
|
15.0 score on a scale
Interval 12.0 to 25.5
|
18.0 score on a scale
Interval 17.0 to 26.0
|
21.0 score on a scale
Interval 18.0 to 26.0
|
17.5 score on a scale
Interval 14.0 to 32.0
|
Adverse Events
LED-RL Phototherapy Group 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LED-RL Phototherapy Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mock Irradiation Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mock Irradiation Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LED-RL Phototherapy Group 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Mock Irradiation Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LED-RL Phototherapy Group 2
n=10 participants at risk
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes.
|
LED-RL Phototherapy Group 1
n=10 participants at risk
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes.
|
Mock Irradiation Group 1
n=10 participants at risk
30 subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 1: Received mock phototherapy for 30 minutes.
|
Mock Irradiation Group 2
n=10 participants at risk
30 subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 2: Received mock phototherapy for 60 minutes.
|
LED-RL Phototherapy Group 3
n=10 participants at risk
30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes.
|
Mock Irradiation Group 3
n=10 participants at risk
Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Mock irradiation group 3: Received mock phototherapy for 90 minutes.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Localized Bulla
|
10.0%
1/10 • Number of events 1 • LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.
|
0.00%
0/10 • LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.
|
0.00%
0/10 • LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.
|
0.00%
0/10 • LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.
|
10.0%
1/10 • Number of events 1 • LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.
|
0.00%
0/10 • LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.
|
|
Skin and subcutaneous tissue disorders
Localized Facial Swelling
|
0.00%
0/10 • LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.
|
0.00%
0/10 • LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.
|
0.00%
0/10 • LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.
|
0.00%
0/10 • LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.
|
10.0%
1/10 • Number of events 1 • LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.
|
0.00%
0/10 • LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.
|
Additional Information
Jared Jagdeo MD, MS
SUNY Downstate Health Sciences University
Phone: 347-466-9263
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place