Efficacy and Safety of Blue Light (453 nm) Treatment for Mild Psoriasis Vulgaris Over Three Months Compared to Vitamin D.

• ClinicalTrials.gov Identifier: NCT02735187
• Recruitment Status: Completed
• First Posted: April 12, 2016
• Results First Posted: January 8, 2019
• Last Update Posted: January 8, 2019
• Sponsor: Philips Electronics Nederland BV
• Information provided by (Responsible Party): Philips Electronics Nederland BV

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Psoriasis Vulgaris
• Interventions: Device: Blue light treatment; Drug: Vitamin D
• Enrollment: 51

Participant Flow

Recruitment Details	A total number of 51 patients were enrolled for the study at 1 study site in Germany between March and April 2016. 140 patients were pre-screened.
Pre-assignment Details

Arm/Group Title	group30	group15
Arm/Group Description	Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)	Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Period Title: Overall Study
Started	25	26
Completed	21	25
Not Completed	4	1

Baseline Characteristics

Arm/Group Title		group30	group15	Total
Arm/Group Description		Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)	Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)	Total of all reporting groups
Overall Number of Baseline Participants		25	26	51
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	25 participants	26 participants	51 participants
		42.4 (13.4)	47.9 (13.7)	45.2 (13.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	26 participants	51 participants
	Female	13 52.0%	16 61.5%	29 56.9%
	Male	12 48.0%	10 38.5%	22 43.1%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Germany	Number Analyzed	25 participants	26 participants	51 participants
		25	26	51
Skin type [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	26 participants	51 participants
	Type I	1 4.0%	0 0.0%	1 2.0%
	Type II	12 48.0%	17 65.4%	29 56.9%
	Type III	12 48.0%	9 34.6%	21 41.2%
	Type IV	0 0.0%	0 0.0%	0 0.0%
	Type V	0 0.0%	0 0.0%	0 0.0%
	Type VI	0 0.0%	0 0.0%	0 0.0%
		[1] Measure Description: Skin type was assessed by a dermatologist according to Fitzpatrick type (I-VI): Type I always burns, never tans (pale white; blond or red hair; blue eyes; freckles). Type II usually burns, tans minimally (white; fair; blond or red hair; blue, green, or hazel eyes) Type III sometimes mild burn, tans uniformly (cream white; fair with any hair or eye color) Type IV burns minimally, always tans well (moderate brown) Type V very rarely burns, tans very easily (dark brown) Type VI Never burns, never tans (deeply pigmented dark brown to darkest brown)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline (Visit 2) of the Local PSI of the Blue Light Treated Area (Group 30) as Compared to the VitaminD Treated Area (Control) at End of Treatment (Week 12).
Description	The local Psoriasis severity index (LPSI) was adapted from the well known PASI. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas (0-4). A total severity score was calculated as the sum of the three symptom ratings (range 0-12). The measure reported is the change in LPSI at end of treatment versus baseline. A negative change indicates an improvement of the LPSI.
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS)

Arm/Group Title	group30 (Blue Light)	group30 (Comparator)
Arm/Group Description:	Treatment of the target area with 30 minutes of blue light at 453nm	Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Overall Number of Participants Analyzed	25	25
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.4 (1.45)	-2.4 (1.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	group30 (Blue Light), group30 (Comparator)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	A paired t-test was applied to test the primary hypothesis. In case the requirements for normality were not met, a non-parametric analysis (Wilcoxon signed rank test) was performed.
Statistical Test of Hypothesis	P-Value	0.6469
	Comments	A probability (P-Value) above 0.05 is considered not to be statistical significant.
	Method	t-test, 2 sided
	Comments	[Not Specified]

2. Secondary Outcome

Title	Change From Baseline (Visit 2) of the Local PSI of the Blue Light Treated Area (Group 15) as Compared to the VitaminD Treated (Control) Area at End of Treatment (Week 12).
Description	The local Psoriasis severity index (LPSI) was adapted from the well known PASI. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas (0-4 each). A total severity score was calculated as the sum of the three symptom ratings (range 0-12). The measure reported is the change in LPSI at end of treatment versus baseline. A negative change indicates an improvement of the LPSI.
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	group15 (Blue Light)	group15 (Comparator)
Arm/Group Description:	Treatment of the target area with 30 minutes of blue light at 453nm	Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Overall Number of Participants Analyzed	26	26
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.4 (1.65)	-2.5 (1.56)

3. Secondary Outcome

Title	Change From Baseline in Patient Self-assessment of Severity of Psoriasis of the Blue Light Treated Area (Group 30) Compared to the VitaminD Treated (Control) Area at Week 12 (VAS Scale).
Description	Patient Rating of severity of Psoriasis Plaques on a 0-10 cm Visual Analogue Scale (VAS) scale. VAS = 0 cm corresponds to no pain,, VAS = 10 cm corresponds to maximal imaginable pain.
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

Full Analysis set

Arm/Group Title	group30 (Blue Light)	group30 (Comparator)
Arm/Group Description:	Treatment of the target area with 30 minutes of blue light at 453nm	Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Overall Number of Participants Analyzed	25	25
Mean (Standard Deviation); Unit of Measure: units on a scale
	-3.82 (2.70)	-3.56 (2.73)

4. Secondary Outcome

Title	Change From Baseline in Patient Self-assessment of Severity of Psoriasis of the Blue Light Treated Area (Group 15) Compared to the VitaminD Treated (Control) Area at Week 12 (VAS Scale).
Description	Patient Rating of severity of Psoriasis Plaques on 0-10 cm Visual Analogue Scale (VAS) scale. VAS = 0 corresponds to no symptoms of Psoriasis, VAS = 10 corresponds to most severe symptoms of Psoriasis.
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

Full Analysis set

Arm/Group Title	group15 (Blue Light)	group15 (Comparator)
Arm/Group Description:	Treatment of the target area with 30 minutes of blue light at 453nm	Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Overall Number of Participants Analyzed	26	26
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.92 (2.44)	-2.44 (2.79)

5. Secondary Outcome

Title	Lesional Erythema Measured by Mexameter Measured at End of Treatment.
Description	Lesional erythema was measured objectively with a measurement device (Mexameter). The Mexameter delivers a two digit number for the redness of the skin (range 0-99). 0 = no redness and 99 = maximal redness.
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

Full Analysis set

Arm/Group Title	group30 (Blue Light)	group30 (Comparator)	group15 (Blue Light)	group15 (Comparator)
Arm/Group Description:	Treatment of the target area with 30 minutes of blue light at 453nm	Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)	Treatment of the target area with 15 minutes of blue light at 453nm	Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Overall Number of Participants Analyzed	25	25	26	26
Mean (Standard Deviation); Unit of Measure: units on a scale
	65.44 (16.29)	65.32 (14.27)	59.88 (10.94)	61.50 (11.75)

6. Secondary Outcome

Title	Patient Satisfaction (Week 12)
Description	Patient satisfaction will be measured by questionnaire using the System usability score (SUS). The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. The higher the score the better the patient satisfaction the better the outcome. The lower the score the worse the patient satisfaction the worse the outcome.
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

Full Analysis set

Arm/Group Title	group30	group15
Arm/Group Description:	Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)	Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Overall Number of Participants Analyzed	21	20
Mean (Standard Deviation); Unit of Measure: units on a scale
	88.62 (7.92)	89.00 (8.71)

7. Other Pre-specified Outcome

Title	Hyperpigmentation of Treated Skin Areas Exposed to Blue Light and Control Area Exposed to Daivonex- Evaluation by Mexameter
Description	Lesional tanning was measured objectively with a measurement device (Mexameter). The Mexameter delivers a two digit number for the brownish color of the skin (range 0-99). 0 = no tanning and 99 = maximal tanning.
Time Frame	week 2-16

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	group30 (Blue Light)	group30 (Comparator)	group15 (Blue Light)	group15 (Comparator)
Arm/Group Description:	Treatment of the target area with 30 minutes of blue light at 453nm	Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)	Treatment of the target area with 15 minutes of blue light at 453nm	Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Overall Number of Participants Analyzed	25	25	26	26
Mean (Standard Deviation); Unit of Measure: units on a scale
week 2	26.72 (7.20)	24.16 (3.77)	24.65 (6.72)	22.92 (3.78)
week 4	25.48 (5.95)	24.52 (5.93)	24.15 (3.90)	23.12 (3.60)
week 8	27.40 (6.89)	25.00 (4.21)	25.31 (8.99)	22.35 (6.24)
week 12/End of treatment	25.60 (5.11)	24.96 (4.23)	26.15 (5.90)	24.15 (5.96)
week 16	25.76 (4.61)	25.16 (4.67)	26.31 (7.04)	25.04 (7.13)

8. Other Pre-specified Outcome

Title	Adverse Events (Serious and Non-serious)
Description	Adverse Events (serious and non-serious) collected during the study conduct.
Time Frame	week 0-16

Outcome Measure Data

Analysis Population Description

Safety set

Arm/Group Title	group30	group15
Arm/Group Description:	Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)	Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Overall Number of Participants Analyzed	25	26
Measure Type: Number; Unit of Measure: Number of adverse events
Any adverse events	4	10
Causal related to IMD	0	0
Causal related to medical procedure	1	0

9. Other Pre-specified Outcome

Title	Adverse Device Effects
Description	Adverse device effects collected during the study conduct.
Time Frame	week 0-16

Outcome Measure Data

Analysis Population Description

Safety set

Arm/Group Title	group30	group15
Arm/Group Description:	Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)	Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Overall Number of Participants Analyzed	25	26
Measure Type: Number; Unit of Measure: Number of adverse device effects
	0	0

10. Other Pre-specified Outcome

Title	Device Deficiencies
Description	The number of device deficiencies was collected throughout the study
Time Frame	week 0-12

Outcome Measure Data

Analysis Population Description

Safety set

Arm/Group Title	group30	group15
Arm/Group Description:	Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)	Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Overall Number of Participants Analyzed	25	26
Measure Type: Number; Unit of Measure: Number of device deficiencies
	2	2

11. Other Pre-specified Outcome

Title	Thermal Comfort
Description	Thermal comfort will be measured by questionaire: How comfortable was this temperature on your skin?
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

Safety set

Arm/Group Title	group30	group15
Arm/Group Description:	Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)	Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Overall Number of Participants Analyzed	25	26
Measure Type: Number; Unit of Measure: Count of Participants
Very uncomfortable	0	0
Uncomfortable	0	0
Slightly uncomfortable	5	4
Just right	9	8
Slightly comfortable	2	3
Comfortable	7	10
Very comfortable	0	0
No data	2	1

Adverse Events

Time Frame	Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Adverse Event Reporting Description	Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
Arm/Group Title	group30		group15
Arm/Group Description	Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)		Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient. Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
All-Cause Mortality
	group30		group15
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/25 (0.00%)		0/26 (0.00%)
Serious Adverse Events
	group30		group15
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0.00%)		3/26 (11.54%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion † 1 [1]	0/25 (0.00%)	0	1/26 (3.85%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ † 1 [2]	0/25 (0.00%)	0	1/26 (3.85%)	1
Psychiatric disorders
Mental disorder † 1 [3]	0/25 (0.00%)	0	1/26 (3.85%)	1
1 Term from vocabulary, MedDRA 19.0; † Indicates events were collected by systematic assessment; [1] Not related to investigational medical device (IMD) or medical procedure; [2] Not on investigational site, not related to IMD or medical procedure; [3] Not related to IMD or medical procedure
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	3%
	group30		group15
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/25 (16.00%)		10/26 (38.46%)
Infections and infestations
Tonsillitis † 1	1/25 (4.00%)	1	1/26 (3.85%)	1
Bronchitis † 1	0/25 (0.00%)	0	1/26 (3.85%)	1
Gastrointestinal viral infection † 1	0/25 (0.00%)	0	1/26 (3.85%)	1
Viral infection † 1	1/25 (4.00%)	1	0/26 (0.00%)	0
Viral upper respiratory tract infection † 1	0/25 (0.00%)	0	1/26 (3.85%)	1
Injury, poisoning and procedural complications
Fall † 1	1/25 (4.00%)	1	0/26 (0.00%)	0
Investigations
Endoscopy upper gastrointestinal tract † 1	0/25 (0.00%)	0	1/26 (3.85%)	1
Musculoskeletal and connective tissue disorders
Back pain † 1	0/25 (0.00%)	0	1/26 (3.85%)	1
Nervous system disorders
Migraine † 1	0/25 (0.00%)	0	1/26 (3.85%)	1
Reproductive system and breast disorders
Postmenopausal haemorrhage † 1	0/25 (0.00%)	0	1/26 (3.85%)	1
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic † 1	0/25 (0.00%)	0	1/26 (3.85%)	1
Skin and subcutaneous tissue disorders
Dermatitis † 1	0/25 (0.00%)	0	1/26 (3.85%)	1
Dermatitis contact † 1	1/25 (4.00%)	1	0/26 (0.00%)	0
1 Term from vocabulary, MedDRA 19.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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: Dr. Joerg Liebmann
• Organization: Philips Light & Health
• Phone: + 49-(0)1733715907
• EMail: joerg.liebmann@philips.com

• Responsible Party: Philips Electronics Nederland BV
• ClinicalTrials.gov Identifier: NCT02735187
• Other Study ID Numbers: Psoriasis-CT03
• First Submitted: March 16, 2016
• First Posted: April 12, 2016
• Results First Submitted: September 12, 2017
• Results First Posted: January 8, 2019
• Last Update Posted: January 8, 2019