Skip to main content
OpenTrials
Completed

NCT Number: NCT02004847

Blue Light for Treating Psoriasis Vulgaris

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psoriasis Vulgaris

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aachen, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

≤10 and Dermatology Life quality index (DLQI) ≤ 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 > 10cm (border to border)
  • If lesion is too large to be fully covered, partial treatment possible
  • Aged ≥ 18 years up to <75 years
  • 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)
  • Willing to abstain from excessive sun / UV exposure (e.g. sunbathe, 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: 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
  • Patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer (i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom- Syndrome)

Treatment and study plan

PSO-CT02

Device

The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light.

Primary outcomes

  1. 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).

    Time frame: baseline and week 12

    In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:

    0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked

    A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst)).

Secondary outcomes

  1. 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)

    Time frame: baseline and week 4

    In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:

    0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked

    A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst)).

  2. 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

    Time frame: Week 12 and week 16

    In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:

    0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked

    A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst)).

  3. 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.

    Time frame: baseline and week 4, 12, 16

    In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:

    0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked

    A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst)).

  4. 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

    Time frame: baseline and week 4, 8, 16

    In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:

    • = no sign
    • = slight
    • = moderate
    • = marked
    • = very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12).

  5. 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

    Time frame: baseline and week 4, 12

    Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.

  6. 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

    Time frame: week 12 and week 16

    Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.

  7. System Usability Scale

    Time frame: week 12

    At the end of treatment (visit 7), the usability of the investigational device was evaluated by a questionnaire presented to the patient in German. The usability was evaluated by using the System Usability Scale (SUS) which is an effective tool for assessing the usability of a device. It provides an easy-to-understand score from 0 (negative) to 100 (positive).

  8. Change From Baseline in Dermatology Life Quality Index (DLQI)

    Time frame: baseline and week 12

    It is a simple 10-question validated questionnaire. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. As the change from baseline is calculated negative values in the Outcome Measure Data indicate an improvement in quality of life.

  9. Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)

    Time frame: patients will be followed for the complete duration of the clinical study for 16 weeks

  10. Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)

    Time frame: week 16

  11. Adverse Device Events (Serious and Non-serious)

    Time frame: week 0, 1, 2, 4, 8, 12, 16

    Adverse device events: Adverse event related to the use of an investigational medical device wich led to any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons.

    Serious adverse device event: Adverse device effect that has resulted in a) led to death, b) led to serious deterioration in the health of the subject, that either resulted in 1) a life-threatening illness or injury, or 2) a permanent impairment of a body structure or a body function, or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) led to foetal distress, foetal death or a congenital abnormality or birth defect.

Other outcomes

  1. Hyperpigmentation of "Normal Skin Areas" Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter

    Time frame: week 4, 12, 16

    Arbitrary units measured by mexameter. Mexameter readings ranged from 0 to 100. Higher values correspond to higher pigmentation levels.

  2. Adverse Events (Serious and Non-serious)

    Time frame: week 0, 1, 2, 4, 8, 12, 16

  3. Thermal Comfort

    Time frame: week 12

    Questionaire

  4. Patient Acceptance of Hyperpigmentation

    Time frame: week 16

    Questionaire

Sponsors and collaborators

Lead sponsor

Philips Electronics Nederland BV

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2013
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.