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

Tracking Information

• First Submitted Date: March 16, 2016
• First Posted Date: April 12, 2016
• Results First Submitted Date: September 12, 2017
• Results First Posted Date: January 8, 2019
• Last Update Posted Date: January 8, 2019
• Study Start Date: March 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 7, 2019)

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). [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: April 11, 2016): 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). [ Time Frame: week 12 ]

Current Secondary Outcome Measures (submitted: January 7, 2019)

• 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). [ Time Frame: 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). [ Time Frame: week 12 ]
  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). [ Time Frame: week 12 ]
  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. [ Time Frame: week 12 ]
  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) [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: April 11, 2016)

• 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). [ Time Frame: week 12 ]
• 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). [ Time Frame: week 12 ]
• 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). [ Time Frame: week 12 ]
• Lesional erythema measured by Mexameter measured at study visits. [ Time Frame: week 2-16 ]
• Patient satisfaction (Week 12) [ Time Frame: week 12 ]
  Patient satisfaction will be measured by questionaire

Current Other Pre-specified Outcome Measures (submitted: January 7, 2019)

• Hyperpigmentation of Treated Skin Areas Exposed to Blue Light and Control Area Exposed to Daivonex- Evaluation by Mexameter [ Time Frame: week 2-16 ]
  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.
• Adverse Events (Serious and Non-serious) [ Time Frame: week 0-16 ]
  Adverse Events (serious and non-serious) collected during the study conduct.
• Adverse Device Effects [ Time Frame: week 0-16 ]
  Adverse device effects collected during the study conduct.
• Device Deficiencies [ Time Frame: week 0-12 ]
  The number of device deficiencies was collected throughout the study
• Thermal Comfort [ Time Frame: week 12 ]
  Thermal comfort will be measured by questionaire: How comfortable was this temperature on your skin?

Original Other Pre-specified Outcome Measures (submitted: April 11, 2016)

• Hyperpigmentation of treated skin areas exposed to blue light and control area exposed to Daivonex- evaluation by Mexameter [ Time Frame: week 2-16 ]
• Adverse events (serious and non-serious) [ Time Frame: week 0-16 ]
• Adverse device events (serious and non-serious) [ Time Frame: week 0-16 ]
• Device deficiencies [ Time Frame: week 0-12 ]
  The number of device deficiencies will be collected throughout the study
• Thermal comfort [ Time Frame: week 12 ]
  Thermal comfort will be measured by questionaire

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Psoriasis Vulgaris

Intervention

• Device: Blue light treatment
  Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.
• Drug: Vitamin D
  Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)

Study Arms

• Active Comparator: group30
  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.
  Interventions:

  • Device: Blue light treatment
  • Drug: Vitamin D
• Active Comparator: group15
  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.
  Interventions:

  • Device: Blue light treatment
  • Drug: Vitamin D

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 7, 2019): 51
• Original Estimated Enrollment (submitted: April 11, 2016): 50
• Actual Study Completion Date: August 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 74 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02735187
• Other Study ID Numbers: Psoriasis-CT03
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Philips Electronics Nederland BV
• Original Responsible Party: Same as current
• Current Study Sponsor: Philips Electronics Nederland BV
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Verena von Felbert, PD Dr.; Universityclinic of the RWTH Aachen

• PRS Account: Philips Electronics Nederland BV
• Verification Date: January 2019