Clinical trial NCT02004847: Blue Light for Treating Psoriasis Vulgaris
Official title: Monocenter, Randomized, Double Blinded, Intraindividual, Exploratory Study of Effectiveness and Safety of 3 Months Treatment With 2 Peak Intensities of 453nm Blue Light for the Treatment of Mild Plaque Type Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis Vulgaris
Lead sponsor: Philips Electronics Nederland BV
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of a blue light device for treating Psoriasis vulgaris. The study will compare a blue light treated plaque with an untreated control plaque. Additionally, two intensities of blue light are compared.

Detailed description: Blue light has been shown to release bioactive nitric oxide (NO) from nitrite and nitrosated proteins found in high concentrations in the skin. This bioactive NO has many physiological functions regulating immune responses, proliferation / differentiation as well as local blood Perfusion of the skin. The study will test the PSO-CT02 device, an new investigational medical device emitting blue light with a peak wavelength of 453nm on treating localised mild Psoriasis vulgaris. It can be worn on the Skin above the effected skin area. In this study Treatment (target) and control area as well as intensity of blue light are randomized. The control area will serve as reference. 50 Patients will treat the target area daily (at least 5 times/week) at home for an initial treatment period of 4 weeks. During those 4 weeks, patients will return to the study site for safety and effectiveness assessments twice. After this initiation period patients will treat their plaque for further 8 weeks (3 times/week). This is followed by a 4 week follow up phase without treatment.

Eligibility criteria: Inclusion Criteria:

1. Signed and dated informed consent prior to any study mandated procedure
2. Good health according to physical examination 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 severity index (PASI) ≤10 and Body surface area (BSA)

   ≤10 and Dermatology Life quality index (DLQI) ≤ 10 at screening.
6. Presence of two comparable psoriatic plaques suitable to be defined as study areas as follows:

   1. located on extremities (plaques located on the palms or sole of the feet are not suitable)
   2. Both areas located either on lower or upper extremity
   3. Can be located on the same extremity
   4. Distance between the two study areas \> 10cm (border to border)
   5. If lesion is too large to be fully covered, partial treatment possible
7. Aged ≥ 18 years up to \<75 years
8. Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year; e.g. oral contraceptives, intra-uterine device \[IUD\] or transdermal contraceptive patch)
9. Willing to abstain from excessive sun / UV exposure (e.g. sunbathe, 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: Malignoma of the skin or severe actinic damage of the skin, atypical 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 genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer (i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom- Syndrome)

Primary outcomes:
measure: Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity (HI) Group) as Compared to the Control Area at End of Treatment (Visit 7, Week 12).
timeFrame: baseline and week 12
Secondary outcomes:
measure: Change From Baseline of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Treatment During the Attack Period (Week 4, Visit 5)
timeFrame: baseline and week 4
measure: Change From Week 12 of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Follow-up
timeFrame: Week 12 and week 16
measure: Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (Low Intensity (LI) Group) as Compared to the Control Area by Week.
timeFrame: baseline and week 4, 12, 16
measure: Difference in Change From Baseline of Local Psoriasis Area Severity Index (PASI) Between Target and Control Area of the High Intensity (HI) Group as Compared to the Low Intensity (LI) Group
timeFrame: baseline and week 4, 8, 16
measure: Change From Baseline of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area
timeFrame: baseline and week 4, 12
measure: Change From Week 12 (End of Treatment) of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area at End of Follow-up
timeFrame: week 12 and week 16
measure: System Usability Scale
timeFrame: week 12
measure: Change From Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: baseline and week 12
measure: Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)
timeFrame: patients will be followed for the complete duration of the clinical study for 16 weeks
measure: Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)
timeFrame: week 16
measure: Adverse Device Events (Serious and Non-serious)
timeFrame: week 0, 1, 2, 4, 8, 12, 16
Other outcomes:
measure: Hyperpigmentation of "Normal Skin Areas" Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter
timeFrame: week 4, 12, 16
measure: Adverse Events (Serious and Non-serious)
timeFrame: week 0, 1, 2, 4, 8, 12, 16
measure: Thermal Comfort
timeFrame: week 12
measure: Patient Acceptance of Hyperpigmentation
timeFrame: week 16
Locations:
city: Aachen
country: Germany
facility: Department of Dermatology and Allergology, Medical faculty of the RWTH Aachen
Study officials:
affiliation: Clinic for Dermatology and Allergology, Medical Faculty of the RWTH Aachen, Germany
name: Verena von Felbert, PD, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfaff S, Liebmann J, Born M, Merk HF, von Felbert V. Prospective Randomized Long-Term Study on the Efficacy and Safety of UV-Free Blue Light for Treating Mild Psoriasis Vulgaris. Dermatology. 2015;231(1):24-34. doi: 10.1159/000430495. Epub 2015 Jun 2.