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Blue Light for Treating Eczema

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ClinicalTrials.gov Identifier: NCT02002871
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : July 20, 2015
Last Update Posted : July 20, 2015
Sponsor:
Information provided by (Responsible Party):
Philips Light and Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Eczema
Intervention Device: PSO-CT02 device
Enrollment 21
Recruitment Details Date of first enrollment: 23.10.2013, University Clinic Aachen Date of LPLV: 17.02.2014
Pre-assignment Details  
Arm/Group Title Blue Light vs Control
Hide Arm/Group Description

Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control.

Period Title: Overall Study
Started 21
Completed 20
Not Completed 1
Arm/Group Title Blue Light vs Control
Hide Arm/Group Description

Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control.

Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
21
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
11
  52.4%
Male
10
  47.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 21 participants
21
1.Primary Outcome
Title Change From Baseline (Visit 2) of the Sum Score of Local Eczema Rating of the Target Area as Compared to the Control Area at End of Treatment
Hide Description The investigator rated the key symptoms erythema, induration/papulation/edema, excoriation, lichenification and crusts on a score of 0-3 (none, mild, moderate, and severe) with half steps allowed. A total severity score was calculated as the sum of the single symptom ratings (range 0-15 whereas 0 (best) - 15 (worst)).
Time Frame at week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants is also 20 because control and treated plaque were anaylsed on the same patient.
Arm/Group Title Blue Light Control
Hide Arm/Group Description:

Light wavelength 453nm

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light.

Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.9  (2.02) -1.3  (2.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Blue Light, Control
Comments The statistical analysis was performed on the difference of the change from baseline of the Blue light treated plaque versus the Control plaque.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0152
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up
Hide Description The investigator rated the key symptoms erythema, induration/papulation/edema, excoriation, lichenification and crusts on a score of 0-3 (none, mild, moderate, and severe) with half steps allowed. A total severity score was calculated as the sum of the single symptom ratings (range 0-15 whereas 0 (best) - 15 (worst)).
Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Blue Light Control
Hide Arm/Group Description:

Light wavelength 453nm

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light.

Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5  (1.54) -0.5  (1.43)
3.Secondary Outcome
Title Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area
Hide Description Higher values describe higher erythema levels.
Time Frame week 4, 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Blue Light Control
Hide Arm/Group Description:

Light wavelength 453nm

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light.

Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: arbitrary units
week 4 4.7  (8.11) -0.9  (10.28)
week 6 1.1  (7.74) 0.3  (7.36)
4.Secondary Outcome
Title Change From Week 4 (End of Treatment) of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area at End of Follow-up
Hide Description Higher values describe a higher level of erythema.
Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Blue Light Control
Hide Arm/Group Description:

Light wavelength 453nm

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light.

Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: arbitrary units
-3.6  (9.38) 1.2  (8.04)
5.Secondary Outcome
Title Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area
Hide Description patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching)
Time Frame week 4, 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Blue Light Control
Hide Arm/Group Description:

Light wavelength 453nm

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light.

Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
week 4 -2.6  (20.72) -15.6  (23.85)
week 6 -10.3  (26.25) -19.6  (27.77)
6.Secondary Outcome
Title Change From Week 4 (End of Treatment) of Patient Rating of Itching of the Target Area as Compared to the Control Area at End of Follow-up
Hide Description patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching).
Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Blue Light Control
Hide Arm/Group Description:

Light wavelength 453nm

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light.

Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.7  (14.11) -4.0  (14.31)
7.Other Pre-specified Outcome
Title Hyperpigmentation – Evaluation by Mexameter
Hide Description Higher values describe a higher level of pigmentation.
Time Frame week 0, 2, 4, 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Blue Light Control
Hide Arm/Group Description:

Light wavelength 453nm

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light.

Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: arbitrary units
week 0 27.8  (6.85) 28.0  (7.99)
week 2 26.3  (6.01) 28.4  (6.04)
week 4 25.6  (5.39) 28.4  (7.71)
week 6 26.5  (6.57) 26.8  (5.51)
8.Other Pre-specified Outcome
Title Adverse Events (Serious and Non-serious)
Hide Description [Not Specified]
Time Frame week 0, 2, 4, 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Blue Light Control
Hide Arm/Group Description:

Light wavelength 453nm

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light.

Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
week 0 0 0
week 2 0 0
week 4 0 0
week 6 0 0
9.Other Pre-specified Outcome
Title Adverse Device Events (Serious and Non-serious)
Hide Description [Not Specified]
Time Frame over 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Blue Light Control
Hide Arm/Group Description:

Light wavelength 453nm

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light.

Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
0 0
10.Other Pre-specified Outcome
Title Device Deficiencies
Hide Description This measure describes device deficiencies in general leading to a non functional device. No specific characteristics were assessed.
Time Frame over 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Blue Light Control
Hide Arm/Group Description:

Light wavelength 453nm

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light.

Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
0 0
11.Other Pre-specified Outcome
Title Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment)
Hide Description Higher values describe a higher level of pigmentation.
Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Blue Light Control
Hide Arm/Group Description:

Light wavelength 453nm

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light.

Contralateral untreated control plaque on the same patient.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: arbitrary units
0.9  (5.78) -1.7  (6.49)
12.Other Pre-specified Outcome
Title Number of Participants With Acceptance of Hyperpigmentation at Week 6
Hide Description Questionaire if hyperpigmentation was acceptable if reported. Outcome was number of patients answering "yes" or "no".
Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
7 patients out of 20 patients reported hyperpigmentation at week 6.
Arm/Group Title Blue Light
Hide Arm/Group Description:

Light wavelength 453nm

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light.

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
Yes 6
No 1
Time Frame Adverse events were collected throughout the whole study period after the patients signed the informed consent untill the last follow up visit (week 0 to week 6)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Blue Light vs Control
Hide Arm/Group Description

Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.

PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control.

All-Cause Mortality
Blue Light vs Control
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Blue Light vs Control
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Blue Light vs Control
Affected / at Risk (%)
Total   0/20 (0.00%) 
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
Name/Title: Prof. Dr. Matthias Born
Organization: Philips GmbH Innovative Technologies Aachen
Phone: +491735321764
Responsible Party: Philips Light and Health
ClinicalTrials.gov Identifier: NCT02002871     History of Changes
Other Study ID Numbers: EczemaCT01
CIV-13-08-011581 ( Other Identifier: Unique identification number EUDAMED )
First Submitted: December 2, 2013
First Posted: December 6, 2013
Results First Submitted: March 16, 2015
Results First Posted: July 20, 2015
Last Update Posted: July 20, 2015