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

Not Applicable

Completed

Conditions: Psoriasis Vulgaris

Interventions: Device: Blue light treatment
Drug: Vitamin D

Registration Number: NCT02735187

Lead Sponsor: Philips Electronics Nederland BV

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 51

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group30	Blue light treatment	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.
group15	Blue light treatment	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.
group30	Vitamin D	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.
group15	Vitamin D	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.

Primary Outcome Measures

Name	Time	Method
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).	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

Name	Time	Method
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).	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.	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.
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).	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).	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.
Patient Satisfaction (Week 12)	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.