Trial Outcomes & Findings for Blue Light for Treating Eczema (NCT NCT02002871)

NCT ID: NCT02002871

Last Updated: 2015-07-20

Results Overview

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)).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: at week 4
• Results posted on: 2015-07-20

Participant Flow

Date of first enrollment: 23.10.2013, University Clinic Aachen Date of LPLV: 17.02.2014

Participant milestones

Measure	Blue Light vs Control 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 Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Blue Light for Treating Eczema

Baseline characteristics by cohort

Measure	Blue Light vs Control n=21 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment Germany	21 participants n=5 Participants

PRIMARY outcome

Timeframe: at week 4

Population: Overall number of participants is also 20 because control and treated plaque were anaylsed on the same patient.

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)).

Outcome measures

Measure	Blue Light n=20 Participants 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.	Control n=20 Participants Contralateral untreated control plaque on the same patient.
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	-1.9 units on a scale Standard Deviation 2.02	-1.3 units on a scale Standard Deviation 2.24

SECONDARY outcome

Timeframe: week 6

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)).

Outcome measures

Measure	Blue Light n=20 Participants 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.	Control n=20 Participants Contralateral untreated control plaque on the same patient.
Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up	-0.5 units on a scale Standard Deviation 1.54	-0.5 units on a scale Standard Deviation 1.43

SECONDARY outcome

Timeframe: week 4, 6

Higher values describe higher erythema levels.

Outcome measures

Measure	Blue Light n=20 Participants 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.	Control n=20 Participants Contralateral untreated control plaque on the same patient.
Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area week 4	4.7 arbitrary units Standard Deviation 8.11	-0.9 arbitrary units Standard Deviation 10.28
Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area week 6	1.1 arbitrary units Standard Deviation 7.74	0.3 arbitrary units Standard Deviation 7.36

SECONDARY outcome

Timeframe: week 6

Higher values describe a higher level of erythema.

Outcome measures

Measure	Blue Light n=20 Participants 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.	Control n=20 Participants Contralateral untreated control plaque on the same patient.
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	-3.6 arbitrary units Standard Deviation 9.38	1.2 arbitrary units Standard Deviation 8.04

SECONDARY outcome

Timeframe: week 4, 6

patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching)

Outcome measures

Measure	Blue Light n=20 Participants 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.	Control n=20 Participants Contralateral untreated control plaque on the same patient.
Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area week 4	-2.6 units on a scale Standard Deviation 20.72	-15.6 units on a scale Standard Deviation 23.85
Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area week 6	-10.3 units on a scale Standard Deviation 26.25	-19.6 units on a scale Standard Deviation 27.77

SECONDARY outcome

Timeframe: week 6

patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching).

Outcome measures

Measure	Blue Light n=20 Participants 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.	Control n=20 Participants Contralateral untreated control plaque on the same patient.
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	-7.7 units on a scale Standard Deviation 14.11	-4.0 units on a scale Standard Deviation 14.31

OTHER_PRE_SPECIFIED outcome

Timeframe: week 0, 2, 4, 6

Higher values describe a higher level of pigmentation.

Outcome measures

Measure	Blue Light n=20 Participants 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.	Control n=20 Participants Contralateral untreated control plaque on the same patient.
Hyperpigmentation - Evaluation by Mexameter week 0	27.8 arbitrary units Standard Deviation 6.85	28.0 arbitrary units Standard Deviation 7.99
Hyperpigmentation - Evaluation by Mexameter week 2	26.3 arbitrary units Standard Deviation 6.01	28.4 arbitrary units Standard Deviation 6.04
Hyperpigmentation - Evaluation by Mexameter week 4	25.6 arbitrary units Standard Deviation 5.39	28.4 arbitrary units Standard Deviation 7.71
Hyperpigmentation - Evaluation by Mexameter week 6	26.5 arbitrary units Standard Deviation 6.57	26.8 arbitrary units Standard Deviation 5.51

OTHER_PRE_SPECIFIED outcome

Timeframe: week 0, 2, 4, 6

Outcome measures

Measure	Blue Light n=20 Participants 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.	Control n=20 Participants Contralateral untreated control plaque on the same patient.
Adverse Events (Serious and Non-serious) week 0	0 participants	0 participants
Adverse Events (Serious and Non-serious) week 2	0 participants	0 participants
Adverse Events (Serious and Non-serious) week 4	0 participants	0 participants
Adverse Events (Serious and Non-serious) week 6	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: over 6 weeks

Outcome measures

Measure	Blue Light n=20 Participants 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.	Control n=20 Participants Contralateral untreated control plaque on the same patient.
Adverse Device Events (Serious and Non-serious)	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: over 6 weeks

This measure describes device deficiencies in general leading to a non functional device. No specific characteristics were assessed.

Outcome measures

Measure	Blue Light n=20 Participants 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.	Control n=20 Participants Contralateral untreated control plaque on the same patient.
Device Deficiencies	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 6

Higher values describe a higher level of pigmentation.

Outcome measures

Measure	Blue Light n=20 Participants 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.	Control n=20 Participants Contralateral untreated control plaque on the same patient.
Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment)	0.9 arbitrary units Standard Deviation 5.78	-1.7 arbitrary units Standard Deviation 6.49

OTHER_PRE_SPECIFIED outcome

Timeframe: week 6

Population: 7 patients out of 20 patients reported hyperpigmentation at week 6.

Questionaire if hyperpigmentation was acceptable if reported. Outcome was number of patients answering "yes" or "no".

Outcome measures

Measure	Blue Light n=7 Participants 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.	Control Contralateral untreated control plaque on the same patient.
Number of Participants With Acceptance of Hyperpigmentation at Week 6 Yes	6 participants	—
Number of Participants With Acceptance of Hyperpigmentation at Week 6 No	1 participants	—

Adverse Events

Blue Light vs Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. Matthias Born

Philips GmbH Innovative Technologies Aachen

Phone: +491735321764

Email: matthias.born@philips.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place