Trial Outcomes & Findings for Blue Light for Treating Psoriasis Vulgaris (NCT NCT02004847)
NCT ID: NCT02004847
Last Updated: 2015-12-18
Results Overview
In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale: 0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst)).
COMPLETED
NA
47 participants
baseline and week 12
2015-12-18
Participant Flow
All patient visits were conducted at the Department of Dermatology and Allergology, RWTH Aachen University Hospital. One hundred and twenty-nine patients were prescreened, 49 patients were screened and 47 enrolled in the study at the time of screening from October 2013 to June 2014.
Two patients were screening failures, so 47 actually started the study.
Participant milestones
| Measure |
High Intensity (HI) vs. Control
PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
|
Low Intensity (LI) vs. Control
PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
High Intensity (HI) vs. Control
PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
|
Low Intensity (LI) vs. Control
PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Blue Light for Treating Psoriasis Vulgaris
Baseline characteristics by cohort
| Measure |
High Intensity (HI) vs Control
n=24 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient.
PSO-CT02: The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light.
|
Low Intensity (LI) vs Control
n=23 Participants
PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient.
PSO-CT02: The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
46.54 years
STANDARD_DEVIATION 13.80 • n=5 Participants
|
49.09 years
STANDARD_DEVIATION 10.68 • n=7 Participants
|
47.79 years
STANDARD_DEVIATION 12.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and week 12Population: Full Analysis set (FAS)
In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale: 0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst)).
Outcome measures
| Measure |
High Intensity (HI)
n=24 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=24 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity (HI) Group) as Compared to the Control Area at End of Treatment (Visit 7, Week 12).
|
-2.38 units on a scale
Standard Deviation 1.53
|
-1.46 units on a scale
Standard Deviation 1.59
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and week 4Population: Full Analysis Set
In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale: 0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst)).
Outcome measures
| Measure |
High Intensity (HI)
n=24 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=24 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Change From Baseline of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Treatment During the Attack Period (Week 4, Visit 5)
|
-1.92 units on a scale
Standard Deviation 1.21
|
-1.33 units on a scale
Standard Deviation 1.66
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12 and week 16Population: Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 and 16
In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale: 0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst)).
Outcome measures
| Measure |
High Intensity (HI)
n=23 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=23 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Change From Week 12 of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Follow-up
|
-0.22 units on a scale
Standard Deviation 1.313
|
-0.43 units on a scale
Standard Deviation 1.590
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and week 4, 12, 16Population: Full Analysis Set (FAS)
In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale: 0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst)).
Outcome measures
| Measure |
High Intensity (HI)
n=23 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=23 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (Low Intensity (LI) Group) as Compared to the Control Area by Week.
week 4
|
-1.83 units on a scale
Standard Deviation 1.557
|
-0.87 units on a scale
Standard Deviation 1.604
|
—
|
—
|
|
Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (Low Intensity (LI) Group) as Compared to the Control Area by Week.
week 12
|
-2.78 units on a scale
Standard Deviation 1.347
|
-2.04 units on a scale
Standard Deviation 1.461
|
—
|
—
|
|
Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (Low Intensity (LI) Group) as Compared to the Control Area by Week.
week 16
|
-3.00 units on a scale
Standard Deviation 1.447
|
-2.50 units on a scale
Standard Deviation 1.655
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and week 4, 8, 16Population: Full Analysis Set (FAS)
In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale: 0\. = no sign 1. = slight 2. = moderate 3. = marked 4. = very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12).
Outcome measures
| Measure |
High Intensity (HI)
n=24 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=24 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
n=23 Participants
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
n=23 Participants
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Difference in Change From Baseline of Local Psoriasis Area Severity Index (PASI) Between Target and Control Area of the High Intensity (HI) Group as Compared to the Low Intensity (LI) Group
week 4 n=24 (HI) n=23 (LI)
|
-1.92 units on a scale
Standard Deviation 1.213
|
-1.33 units on a scale
Standard Deviation 1.659
|
-1.83 units on a scale
Standard Deviation 1.557
|
-0.87 units on a scale
Standard Deviation 1.604
|
|
Difference in Change From Baseline of Local Psoriasis Area Severity Index (PASI) Between Target and Control Area of the High Intensity (HI) Group as Compared to the Low Intensity (LI) Group
week 8 n=24 (HI) n=23 (LI)
|
-2.25 units on a scale
Standard Deviation 1.359
|
-1.50 units on a scale
Standard Deviation 1.719
|
-1.78 units on a scale
Standard Deviation 1.650
|
-1.30 units on a scale
Standard Deviation 1.460
|
|
Difference in Change From Baseline of Local Psoriasis Area Severity Index (PASI) Between Target and Control Area of the High Intensity (HI) Group as Compared to the Low Intensity (LI) Group
week 16 n=23 (HI) n=22 (LI)
|
-2.57 units on a scale
Standard Deviation 1.619
|
-1.87 units on a scale
Standard Deviation 1.842
|
-3.00 units on a scale
Standard Deviation 1.447
|
-2.50 units on a scale
Standard Deviation 1.655
|
SECONDARY outcome
Timeframe: baseline and week 4, 12Population: Full Analysis Set (FAS)
Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.
Outcome measures
| Measure |
High Intensity (HI)
n=24 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=24 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
n=23 Participants
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
n=23 Participants
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Change From Baseline of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area
4 weeks
|
3.38 arbitrary units
Standard Deviation 13.87
|
1.00 arbitrary units
Standard Deviation 13.45
|
0.13 arbitrary units
Standard Deviation 11.90
|
2.87 arbitrary units
Standard Deviation 12.00
|
|
Change From Baseline of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area
12 weeks
|
-0.38 arbitrary units
Standard Deviation 11.02
|
-0.58 arbitrary units
Standard Deviation 11.82
|
5.50 arbitrary units
Standard Deviation 16.66
|
1.05 arbitrary units
Standard Deviation 9.77
|
SECONDARY outcome
Timeframe: week 12 and week 16Population: Full Analysis Set (FAS); due to one drop out in each group this number is 23 for HI Group and 22 for LI group at week 12 and 16
Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.
Outcome measures
| Measure |
High Intensity (HI)
n=23 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=23 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
n=22 Participants
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
n=22 Participants
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Change From Week 12 (End of Treatment) of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area at End of Follow-up
|
-2.26 arbitrary units
Standard Deviation 14.08
|
2.00 arbitrary units
Standard Deviation 14.97
|
-1.64 arbitrary units
Standard Deviation 12.07
|
3.23 arbitrary units
Standard Deviation 9.97
|
SECONDARY outcome
Timeframe: week 12Population: Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 for HI group. Only 17 of 22 patients completed the questionaire in the LI group.
At the end of treatment (visit 7), the usability of the investigational device was evaluated by a questionnaire presented to the patient in German. The usability was evaluated by using the System Usability Scale (SUS) which is an effective tool for assessing the usability of a device. It provides an easy-to-understand score from 0 (negative) to 100 (positive).
Outcome measures
| Measure |
High Intensity (HI)
n=23 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=17 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
System Usability Scale
|
88.37 units on a scale
Standard Deviation 11.62
|
88.53 units on a scale
Standard Deviation 9.02
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and week 12Population: Full Analysis Set (FAS)
It is a simple 10-question validated questionnaire. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. As the change from baseline is calculated negative values in the Outcome Measure Data indicate an improvement in quality of life.
Outcome measures
| Measure |
High Intensity (HI)
n=24 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=22 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI)
|
-0.75 units on a scale
Standard Deviation 2.98
|
-0.36 units on a scale
Standard Deviation 4.18
|
—
|
—
|
SECONDARY outcome
Timeframe: patients will be followed for the complete duration of the clinical study for 16 weeksPopulation: Full Analysis Set (FAS); Not all patients requested co-use of vitamin D. Only 17 in HI group and 16 in LI group requested co-use of vitamin D
Outcome measures
| Measure |
High Intensity (HI)
n=17 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=16 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)
|
46.35 days
Standard Deviation 17.68
|
48.25 days
Standard Deviation 26.36
|
—
|
—
|
SECONDARY outcome
Timeframe: week 16Population: Full Analysis Set (FAS); Not all patients requested co-use of vitamin D. Only 17 in HI group and 16 in LI group requested co-use of vitamin D
Outcome measures
| Measure |
High Intensity (HI)
n=17 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=16 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)
|
62.65 days
Standard Deviation 23.82
|
53.44 days
Standard Deviation 33.66
|
—
|
—
|
SECONDARY outcome
Timeframe: week 0, 1, 2, 4, 8, 12, 16Population: Safety Set (SAF)
Adverse device events: Adverse event related to the use of an investigational medical device wich led to any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons. Serious adverse device event: Adverse device effect that has resulted in a) led to death, b) led to serious deterioration in the health of the subject, that either resulted in 1) a life-threatening illness or injury, or 2) a permanent impairment of a body structure or a body function, or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) led to foetal distress, foetal death or a congenital abnormality or birth defect.
Outcome measures
| Measure |
High Intensity (HI)
n=24 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=23 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Adverse Device Events (Serious and Non-serious)
non serious
|
0 number of participants
|
0 number of participants
|
—
|
—
|
|
Adverse Device Events (Serious and Non-serious)
serious
|
0 number of participants
|
0 number of participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 4, 12, 16Population: Safety Set (SAF)
Arbitrary units measured by mexameter. Mexameter readings ranged from 0 to 100. Higher values correspond to higher pigmentation levels.
Outcome measures
| Measure |
High Intensity (HI)
n=24 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=24 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
n=23 Participants
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
n=23 Participants
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Hyperpigmentation of "Normal Skin Areas" Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter
4 weeks
|
25.88 arbitrary units
Standard Deviation 6.02
|
26.58 arbitrary units
Standard Deviation 6.80
|
25.09 arbitrary units
Standard Deviation 7.86
|
23.48 arbitrary units
Standard Deviation 5.69
|
|
Hyperpigmentation of "Normal Skin Areas" Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter
12 weeks
|
27.71 arbitrary units
Standard Deviation 6.75
|
25.17 arbitrary units
Standard Deviation 4.65
|
24.50 arbitrary units
Standard Deviation 6.81
|
24.18 arbitrary units
Standard Deviation 5.88
|
|
Hyperpigmentation of "Normal Skin Areas" Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter
16 weeks
|
27.17 arbitrary units
Standard Deviation 8.61
|
26.39 arbitrary units
Standard Deviation 5.99
|
25.05 arbitrary units
Standard Deviation 6.45
|
22.95 arbitrary units
Standard Deviation 6.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 0, 1, 2, 4, 8, 12, 16Population: Safety Set (SAF)
Outcome measures
| Measure |
High Intensity (HI)
n=24 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=23 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Adverse Events (Serious and Non-serious)
adverse events
|
11 number of participants
|
8 number of participants
|
—
|
—
|
|
Adverse Events (Serious and Non-serious)
serious adverse events
|
0 number of participants
|
0 number of participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 12Population: Full Analysis Set
Questionaire
Outcome measures
| Measure |
High Intensity (HI)
n=24 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=23 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Thermal Comfort
Very uncomfortable
|
0.00 percentage of participants
|
0.00 percentage of participants
|
—
|
—
|
|
Thermal Comfort
Uncomfortable
|
0.00 percentage of participants
|
0.00 percentage of participants
|
—
|
—
|
|
Thermal Comfort
A little uncomfortable
|
4.17 percentage of participants
|
8.70 percentage of participants
|
—
|
—
|
|
Thermal Comfort
Just right
|
25.00 percentage of participants
|
30.43 percentage of participants
|
—
|
—
|
|
Thermal Comfort
A little comfortable
|
4.17 percentage of participants
|
8.70 percentage of participants
|
—
|
—
|
|
Thermal Comfort
Comfortable
|
58.33 percentage of participants
|
47.83 percentage of participants
|
—
|
—
|
|
Thermal Comfort
Very comfortable
|
8.33 percentage of participants
|
0.00 percentage of participants
|
—
|
—
|
|
Thermal Comfort
Missing
|
0.00 percentage of participants
|
4.35 percentage of participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 16Population: Safety set (SAF)
Questionaire
Outcome measures
| Measure |
High Intensity (HI)
n=24 Participants
PSO-CT02 device: Light wavelength 453nm, high intensity
|
Control (HI)
n=23 Participants
Contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
PSO-CT02 device: Light wavelength 453nm, low intensity
|
Control (LI)
Contralateral untreated control plaque on the same patient.
|
|---|---|---|---|---|
|
Patient Acceptance of Hyperpigmentation
Acceptable
|
50.00 percentage of participants
|
47.83 percentage of participants
|
—
|
—
|
|
Patient Acceptance of Hyperpigmentation
No Hyperpigmentation
|
41.67 percentage of participants
|
47.83 percentage of participants
|
—
|
—
|
|
Patient Acceptance of Hyperpigmentation
missing data
|
8.33 percentage of participants
|
4.34 percentage of participants
|
—
|
—
|
Adverse Events
High Intensity (HI)
Low Intensity (LI)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Intensity (HI)
n=24 participants at risk
PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
|
Low Intensity (LI)
n=23 participants at risk
PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
|
|---|---|---|
|
Ear and labyrinth disorders
tinnitus
|
0.00%
0/24 • 16 weeks
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
|
General disorders
Influenza like illness
|
0.00%
0/24 • 16 weeks
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Immune system disorders
Drug hypersensitivity
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
|
Immune system disorders
Seasonal allergy
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
|
Infections and infestations
Cystitis
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
|
Infections and infestations
Gastroenteritis
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Infections and infestations
Herpes virus infection
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
|
Infections and infestations
Herpes zoster
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Infections and infestations
Sinobronchitis
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
|
Infections and infestations
Tonsillitis
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/24 • 16 weeks
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/24 • 16 weeks
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
12.5%
3/24 • Number of events 3 • 16 weeks
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Surgical and medical procedures
Knee operation
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/24 • 16 weeks
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • 16 weeks
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
Additional Information
Prof. Dr. Matthias Born
Philips GmbH Innovative Technologies Aachen
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place