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

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Blue light treatment
Vitamin D
Sponsored by
Philips Electronics Nederland BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed and dated informed consent prior to any study-mandated procedure
  2. Good health as determined by the Investigator
  3. Willing and able to comply with study requirements
  4. Skin type I-IV according to Fitzpatrick
  5. Mild plaque-type psoriasis vulgaris with a Psoriasis Area and Severity Index (PASI) ≤ 10 and body surface area (BSA) ≤ 10 at screening.

  6. Presence of two comparable psoriatic plaques suitable to be defined as study areas as follows:

    • located on extremities (plaques located on the palms or sole of the feet are not suitable)
    • Both areas located either on lower or upper extremity
    • Can be located on the same extremity
    • Distance between the two study areas ≥ 11cm (border to border)
    • If lesion is too large to be fully covered, partial treatment possible
  7. Otherwise healthy according to physical examination
  8. Aged 18 years up to ≤74 years
  9. Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1per cent per year; e.g. oral contraceptives, intra-uterine device (IUD) or transdermal contraceptive patch)
  10. Willing to abstain from excessive sun / UV exposure (e.g. sunbath, solarium) during the course of the study

Exclusion Criteria:

General

  1. Inmates of psychiatric wards, prisons, or other state institutions
  2. Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
  3. Participation in another clinical trial within the last 30 days
  4. Pregnant or lactating women Medical History
  5. Photodermatosis and/or Photosensitivity
  6. Porphyria and/or hypersensitivity to porphyrins
  7. Patients with current diagnosis of erythrodermic, exfoliative or pustular psoriasis
  8. Congenital or acquired immunodeficiency
  9. Patients with any of the following conditions present on the study areas: naevi or signs of hyperpigmentation, viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin
  10. Patients with any of the following conditions present or who have been diagnosed in the past with any of the following conditions on the study areas: skin cancer, severe actinic damage and other precancerous lesions

  11. Patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer ( i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom-Syndrome) Concomitant medication/treatment in medical history and during the study Required

    • Treatment of target and control area with Excipial U10 Lipolotio (Galderma)
    • Treatment of control area with Daivonex (Leo Pharma) Allowed
    • Topical treatment of non-study areas with Vitamin D or WHO group I-II corticosteroids or mometasone Not allowed Within 3 months prior to baseline
    • ustekinumab Within 2 months prior to baseline
    • adalimumab, alefacept, infliximab Within 1 month prior to baseline
    • Etanercept
    • Systemic corticosteroids
    • Retinoids
    • Immunosuppressants (e.g. methotrexate, ciclosporin, azathioprine, chemotherapeutics)
    • oral psoralen with ultraviolet A (PUVA)
    • Topical or intranasal/inhalation therapy with potent or very potent (WHO group III-IV) corticosteroids

Within 2 weeks prior to baseline

  • ultraviolet B light (UVB) / ultraviolet A light (UVA)
  • Topical therapy with
  • WHO group I-II corticosteroids
  • Topical retinoids
  • Vitamin D analogues
  • Topical immunomodulators (e.g. calcineurin inhibitors)
  • Anthracen derivatives
  • Tar
  • Salicylic acid

  • Intranasal/inhalation therapy with WHO group I-II corticosteroids At baseline

    • Photo-sensitizing medication (e.g. psoralen, tetracycline, nalidixic acid, furosemide, amiodarone, phenotiacine, chinclone, fibrates, hypericumperforatum, arnica, valerian, tar, psoralen, ketoprofen) or colours (e.g. thiazide, toluidine blue, eosin, methylene blue, rose Bengal, acridine)
    • Initiation of, or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and angiotensin converting enzyme (ACE) inhibitors)

Sites / Locations

  • Department of Dermatology and Allergology, Medical faculty of the RWTH Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group30

group15

Arm Description

Treatment of the target area with 30 minutes of blue light at 453nm compared to Vitamin D creme Daivonex on contralateral Plaque of same patient.

Treatment of the target area with 15 minutes of blue light at 453nm compared to Vitamin D creme Daivonex on contralateral Plaque of same patient.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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).
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.
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).
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.
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).
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.
Lesional Erythema Measured by Mexameter Measured at End of Treatment.
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.
Patient Satisfaction (Week 12)
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.

Full Information

First Posted
March 16, 2016
Last Updated
January 7, 2019
Sponsor
Philips Electronics Nederland BV
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1. Study Identification

Unique Protocol Identification Number
NCT02735187
Brief Title
Efficacy and Safety of Blue Light (453 nm) Treatment for Mild Psoriasis Vulgaris Over Three Months Compared to Vitamin D.
Official Title
Monocenter, Randomized, Blinded, Intraindividual Study Evaluating Efficacy and Safety of Blue Light (453 nm) Treatment for Mild Psoriasis Vulgaris Over Three Months Compared to Vitamin D
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Electronics Nederland BV

4. Oversight

5. Study Description

Brief Summary
Patients will be screened up to 28 days before start of treatment. During the screening visit, the purpose and procedures of the study will be explained to potential patients and informed consent will be obtained. At the baseline visit, all inclusion and exclusion criteria will be re-assessed. Eligible patients will be randomized to treatment of the target area with either 30 minutes (group30) or 15 minutes (group15) blue light at 600 milliwatt per square centimeter (mW/cm²). Additionally, two study areas with similar clinical symptomatology will be determined and will be randomized to blue light treated area and Daivonex (Vitamin D) treated area. After randomization, patients will be trained on a demonstrator device (no actual treatment to ensure investigator is blinded as to which group the patient is randomized to) as well as the Daivonex cream. After patients have been instructed, treatment of the areas will be applied daily (once per day, 5-7 times / week) at home for a treatment period of 12 weeks. During those 12 weeks, patients will return to the study site for safety and effectiveness assessments at week 2, 4, 8 and week 12. A phone call visit will be performed after one week of treatment to check for any adverse events or problems in handling the device or the cream. The visit at week 12 serves as end of treatment visit. The patients will be followed-up for another 4 weeks. Treatment responses will be photo documented.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group30
Arm Type
Active Comparator
Arm Description
Treatment of the target area with 30 minutes of blue light at 453nm compared to Vitamin D creme Daivonex on contralateral Plaque of same patient.
Arm Title
group15
Arm Type
Active Comparator
Arm Description
Treatment of the target area with 15 minutes of blue light at 453nm compared to Vitamin D creme Daivonex on contralateral Plaque of same patient.
Intervention Type
Device
Intervention Name(s)
Blue light treatment
Intervention Description
Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
Other Pre-specified Outcome Measures:
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
Title
Adverse Events (Serious and Non-serious)
Description
Adverse Events (serious and non-serious) collected during the study conduct.
Time Frame
week 0-16
Title
Adverse Device Effects
Description
Adverse device effects collected during the study conduct.
Time Frame
week 0-16
Title
Device Deficiencies
Description
The number of device deficiencies was collected throughout the study
Time Frame
week 0-12
Title
Thermal Comfort
Description
Thermal comfort will be measured by questionaire: How comfortable was this temperature on your skin?
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and dated informed consent prior to any study-mandated procedure Good health as determined by the Investigator Willing and able to comply with study requirements Skin type I-IV according to Fitzpatrick Mild plaque-type psoriasis vulgaris with a Psoriasis Area and Severity Index (PASI) ≤ 10 and body surface area (BSA) ≤ 10 at screening. Presence of two comparable psoriatic plaques suitable to be defined as study areas as follows: located on extremities (plaques located on the palms or sole of the feet are not suitable) Both areas located either on lower or upper extremity Can be located on the same extremity Distance between the two study areas ≥ 11cm (border to border) If lesion is too large to be fully covered, partial treatment possible Otherwise healthy according to physical examination Aged 18 years up to ≤74 years Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1per cent per year; e.g. oral contraceptives, intra-uterine device (IUD) or transdermal contraceptive patch) Willing to abstain from excessive sun / UV exposure (e.g. sunbath, solarium) during the course of the study Exclusion Criteria: General Inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Participation in another clinical trial within the last 30 days Pregnant or lactating women Medical History Photodermatosis and/or Photosensitivity Porphyria and/or hypersensitivity to porphyrins Patients with current diagnosis of erythrodermic, exfoliative or pustular psoriasis Congenital or acquired immunodeficiency Patients with any of the following conditions present on the study areas: naevi or signs of hyperpigmentation, viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin Patients with any of the following conditions present or who have been diagnosed in the past with any of the following conditions on the study areas: skin cancer, severe actinic damage and other precancerous lesions Patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer ( i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom-Syndrome) Concomitant medication/treatment in medical history and during the study Required Treatment of target and control area with Excipial U10 Lipolotio (Galderma) Treatment of control area with Daivonex (Leo Pharma) Allowed Topical treatment of non-study areas with Vitamin D or WHO group I-II corticosteroids or mometasone Not allowed Within 3 months prior to baseline ustekinumab Within 2 months prior to baseline adalimumab, alefacept, infliximab Within 1 month prior to baseline Etanercept Systemic corticosteroids Retinoids Immunosuppressants (e.g. methotrexate, ciclosporin, azathioprine, chemotherapeutics) oral psoralen with ultraviolet A (PUVA) Topical or intranasal/inhalation therapy with potent or very potent (WHO group III-IV) corticosteroids Within 2 weeks prior to baseline ultraviolet B light (UVB) / ultraviolet A light (UVA) Topical therapy with WHO group I-II corticosteroids Topical retinoids Vitamin D analogues Topical immunomodulators (e.g. calcineurin inhibitors) Anthracen derivatives Tar Salicylic acid Intranasal/inhalation therapy with WHO group I-II corticosteroids At baseline Photo-sensitizing medication (e.g. psoralen, tetracycline, nalidixic acid, furosemide, amiodarone, phenotiacine, chinclone, fibrates, hypericumperforatum, arnica, valerian, tar, psoralen, ketoprofen) or colours (e.g. thiazide, toluidine blue, eosin, methylene blue, rose Bengal, acridine) Initiation of, or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and angiotensin converting enzyme (ACE) inhibitors)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Verena von Felbert, PD Dr.
Organizational Affiliation
Universityclinic of the RWTH Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology and Allergology, Medical faculty of the RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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

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