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Blue Light for Treating Psoriasis Vulgaris

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ClinicalTrials.gov Identifier: NCT02004847
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : November 18, 2015
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Philips Electronics Nederland BV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis Vulgaris
Intervention Device: PSO-CT02
Enrollment 47
Recruitment Details 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.
Pre-assignment Details Two patients were screening failures, so 47 actually started the study.
Arm/Group Title High Intensity (HI) vs. Control Low Intensity (LI) vs. Control
Hide Arm/Group Description PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient. PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
Period Title: Overall Study
Started 24 23
Completed 23 22
Not Completed 1 1
Reason Not Completed
Protocol Violation             1             1
Arm/Group Title High Intensity (HI) vs Control Low Intensity (LI) vs Control Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 24 23 47
Hide Baseline Analysis Population Description
Full Aanalysis Set (FAS)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 23 participants 47 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
  95.8%
22
  95.7%
45
  95.7%
>=65 years
1
   4.2%
1
   4.3%
2
   4.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 23 participants 47 participants
46.54  (13.80) 49.09  (10.68) 47.79  (12.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 23 participants 47 participants
Female
9
  37.5%
8
  34.8%
17
  36.2%
Male
15
  62.5%
15
  65.2%
30
  63.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 24 participants 23 participants 47 participants
24 23 47
1.Primary Outcome
Title 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).
Hide Description

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)).

Time Frame baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (FAS)
Arm/Group Title High Intensity (HI) Control (HI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity
Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.38  (1.53) -1.46  (1.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Intensity (HI), Control (HI)
Comments Statistically analysed were the difference in change from baseline to the end of treatment (week 12) of the target plaque compared to the control plaque.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title 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)
Hide Description

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)).

Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title High Intensity (HI) Control (HI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity
Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.92  (1.21) -1.33  (1.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Intensity (HI), Control (HI)
Comments Statistically analysed were the difference in change from baseline to the end of treatment during the attack period (week 4) of the target plaque compared to the control plaque.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0036
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title 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
Hide Description

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)).

Time Frame Week 12 and week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 and 16
Arm/Group Title High Intensity (HI) Control (HI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity
Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.22  (1.313) -0.43  (1.590)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Intensity (HI), Control (HI)
Comments Statistically analysed were the difference in change from end of treatment (week 12, visit 7) to end of follow up (week 16, visit 8) of the target plaque compared to the control plaque.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3075
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title 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.
Hide Description

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)).

Time Frame baseline and week 4, 12, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Low Intensity Control (LI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, low intensity
Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
week 4 -1.83  (1.557) -0.87  (1.604)
week 12 -2.78  (1.347) -2.04  (1.461)
week 16 -3.00  (1.447) -2.50  (1.655)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Intensity, Control (LI)
Comments Statistically analysed were the difference in change from baseline to week 4 of the target plaque compared to the control plaque.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0140
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Intensity, Control (LI)
Comments Statistically analysed were the difference in change from baseline to week 12 of the target plaque compared to the control plaque.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0064
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Low Intensity, Control (LI)
Comments Statistically analysed were the difference in change from baseline to week 16 of the target plaque compared to the control plaque.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1020
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title 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
Hide Description

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).
Time Frame baseline and week 4, 8, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title High Intensity (HI) Control (HI) Low Intensity (LI) Control (LI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity
Contralateral untreated control plaque on the same patient
PSO-CT02 device: Light wavelength 453nm, low intensity
Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 24 24 23 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
week 4 n=24 (HI) n=23 (LI) -1.92  (1.213) -1.33  (1.659) -1.83  (1.557) -0.87  (1.604)
week 8 n=24 (HI) n=23 (LI) -2.25  (1.359) -1.50  (1.719) -1.78  (1.650) -1.30  (1.460)
week 16 n=23 (HI) n=22 (LI) -2.57  (1.619) -1.87  (1.842) -3.00  (1.447) -2.50  (1.655)
6.Secondary Outcome
Title 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
Hide Description Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.
Time Frame baseline and week 4, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title High Intensity (HI) Control (HI) Low Intensity (LI) Control (LI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
Contralateral untreated control plaque on the same patient
PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 24 24 23 23
Mean (Standard Deviation)
Unit of Measure: arbitrary units
4 weeks 3.38  (13.87) 1.00  (13.45) 0.13  (11.90) 2.87  (12.00)
12 weeks -0.38  (11.02) -0.58  (11.82) 5.50  (16.66) 1.05  (9.77)
7.Secondary Outcome
Title 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
Hide Description Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.
Time Frame week 12 and week 16
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title High Intensity (HI) Control (HI) Low Intensity (LI) Control (LI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
Contralateral untreated control plaque on the same patient
PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
Contralateral untreated control plaque on the same patient
Overall Number of Participants Analyzed 23 23 22 22
Mean (Standard Deviation)
Unit of Measure: arbitrary units
-2.26  (14.08) 2.00  (14.97) -1.64  (12.07) 3.23  (9.97)
8.Secondary Outcome
Title System Usability Scale
Hide Description 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).
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title High Intensity (HI) Low Intensity (LI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 23 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
88.37  (11.62) 88.53  (9.02)
9.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI)
Hide Description 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.
Time Frame baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title High Intensity (HI) Low Intensity (LI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.75  (2.98) -0.36  (4.18)
10.Secondary Outcome
Title Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)
Hide Description [Not Specified]
Time Frame patients will be followed for the complete duration of the clinical study for 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title High Intensity (HI) Low Intensity (LI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 17 16
Mean (Standard Deviation)
Unit of Measure: days
46.35  (17.68) 48.25  (26.36)
11.Secondary Outcome
Title Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)
Hide Description [Not Specified]
Time Frame week 16
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title High Intensity (HI) Low Intensity (LI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 17 16
Mean (Standard Deviation)
Unit of Measure: days
62.65  (23.82) 53.44  (33.66)
12.Secondary Outcome
Title Adverse Device Events (Serious and Non-serious)
Hide Description

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.

Time Frame week 0, 1, 2, 4, 8, 12, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SAF)
Arm/Group Title High Intensity (HI) Low Intensity (LI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 24 23
Measure Type: Number
Unit of Measure: number of participants
non serious 0 0
serious 0 0
13.Other Pre-specified Outcome
Title Hyperpigmentation of "Normal Skin Areas" Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter
Hide Description Arbitrary units measured by mexameter. Mexameter readings ranged from 0 to 100. Higher values correspond to higher pigmentation levels.
Time Frame week 4, 12, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SAF)
Arm/Group Title High Intensity (HI) Control (HI) Low Intensity (LI) Control (LI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity
Contralateral untreated control plaque on the same patient
PSO-CT02 device: Light wavelength 453nm, low intensity
Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 24 24 23 23
Mean (Standard Deviation)
Unit of Measure: arbitrary units
4 weeks 25.88  (6.02) 26.58  (6.80) 25.09  (7.86) 23.48  (5.69)
12 weeks 27.71  (6.75) 25.17  (4.65) 24.50  (6.81) 24.18  (5.88)
16 weeks 27.17  (8.61) 26.39  (5.99) 25.05  (6.45) 22.95  (6.22)
14.Other Pre-specified Outcome
Title Adverse Events (Serious and Non-serious)
Hide Description [Not Specified]
Time Frame week 0, 1, 2, 4, 8, 12, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SAF)
Arm/Group Title High Intensity (HI) Low Intensity (LI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 24 23
Measure Type: Number
Unit of Measure: number of participants
adverse events 11 8
serious adverse events 0 0
15.Other Pre-specified Outcome
Title Thermal Comfort
Hide Description Questionaire
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title High Intensity (HI) Low Intensity (LI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 24 23
Measure Type: Number
Unit of Measure: percentage of participants
Very uncomfortable 0.00 0.00
Uncomfortable 0.00 0.00
A little uncomfortable 4.17 8.70
Just right 25.00 30.43
A little comfortable 4.17 8.70
Comfortable 58.33 47.83
Very comfortable 8.33 0.00
Missing 0.00 4.35
16.Other Pre-specified Outcome
Title Patient Acceptance of Hyperpigmentation
Hide Description Questionaire
Time Frame week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set (SAF)
Arm/Group Title High Intensity (HI) Low Intensity (LI)
Hide Arm/Group Description:
PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 24 23
Measure Type: Number
Unit of Measure: percentage of participants
Acceptable 50.00 47.83
No Hyperpigmentation 41.67 47.83
missing data 8.33 4.34
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Intensity (HI) Low Intensity (LI)
Hide Arm/Group Description PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient. PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
All-Cause Mortality
High Intensity (HI) Low Intensity (LI)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High Intensity (HI) Low Intensity (LI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/23 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Intensity (HI) Low Intensity (LI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/24 (45.83%)      8/23 (34.78%)    
Ear and labyrinth disorders     
tinnitus  1  0/24 (0.00%)  0 1/23 (4.35%)  1
Gastrointestinal disorders     
Gastrooesophageal reflux disease  1  1/24 (4.17%)  1 0/23 (0.00%)  0
General disorders     
Influenza like illness  1  0/24 (0.00%)  0 1/23 (4.35%)  1
Immune system disorders     
Drug hypersensitivity  1  1/24 (4.17%)  1 0/23 (0.00%)  0
Seasonal allergy  1  1/24 (4.17%)  1 0/23 (0.00%)  0
Infections and infestations     
Cystitis  1  1/24 (4.17%)  1 0/23 (0.00%)  0
Gastroenteritis  1  1/24 (4.17%)  1 2/23 (8.70%)  2
Herpes virus infection  1  1/24 (4.17%)  1 0/23 (0.00%)  0
Herpes zoster  1  1/24 (4.17%)  1 0/23 (0.00%)  0
Nasopharyngitis  1  1/24 (4.17%)  1 2/23 (8.70%)  2
Sinobronchitis  1  1/24 (4.17%)  1 0/23 (0.00%)  0
Sinusitis  1  1/24 (4.17%)  1 0/23 (0.00%)  0
Tonsillitis  1  1/24 (4.17%)  1 0/23 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal stiffness  1  0/24 (0.00%)  0 1/23 (4.35%)  1
Sacroiliitis  1  0/24 (0.00%)  0 1/23 (4.35%)  1
Skin and subcutaneous tissue disorders     
Drug eruption  1  1/24 (4.17%)  1 0/23 (0.00%)  0
Psoriasis  1  3/24 (12.50%)  3 2/23 (8.70%)  2
Surgical and medical procedures     
Knee operation  1  1/24 (4.17%)  1 0/23 (0.00%)  0
Tooth extraction  1  0/24 (0.00%)  0 1/23 (4.35%)  1
Vascular disorders     
Hypertension  1  0/24 (0.00%)  0 1/23 (4.35%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Dr. Matthias Born
Organization: Philips GmbH Innovative Technologies Aachen
Phone: +491735321764
EMail: matthias.born@philips.com
Layout table for additonal information
Responsible Party: Philips Electronics Nederland BV
ClinicalTrials.gov Identifier: NCT02004847     History of Changes
Other Study ID Numbers: PsoriasisCT02
First Submitted: November 19, 2013
First Posted: December 9, 2013
Results First Submitted: August 12, 2015
Results First Posted: November 18, 2015
Last Update Posted: December 18, 2015