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Blue Light for Treating Psoriasis Vulgaris

Primary Purpose

Psoriasis Vulgaris

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

PSO-CT02

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
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
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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

High Intensity (HI) vs control

Low Intensity (LI) vs control

Arm Description

PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient.

PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient.

Outcomes

Primary Outcome Measures

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).

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 Outcome Measures

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)

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

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.

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

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 = slight = moderate = marked = very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12).

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

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

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

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

System Usability Scale

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).

Change From Baseline in Dermatology Life Quality Index (DLQI)

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.

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

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

Adverse Device Events (Serious and Non-serious)

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.

Full Information

NCT ID

NCT02004847

First Posted

November 19, 2013

Last Updated

November 17, 2015

Sponsor

Philips Electronics Nederland BV

1. Study Identification

Unique Protocol Identification Number

NCT02004847

Brief Title

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

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Philips Electronics Nederland BV

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High Intensity (HI) vs control

Arm Type

Experimental

Arm Description

PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient.

Arm Title

Low Intensity (LI) vs control

Arm Type

Experimental

Arm Description

PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient.

Intervention Type

Device

Intervention Name(s)

PSO-CT02

Intervention Description

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 Outcome Measure Information:

Title

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).

Description

Time Frame

baseline and week 12

Secondary Outcome Measure Information:

Title

Description

Time Frame

baseline and week 4

Title

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

Description

Time Frame

Week 12 and week 16

Title

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.

Description

Time Frame

baseline and week 4, 12, 16

Title

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

Description

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 = slight = moderate = marked = very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12).

Time Frame

baseline and week 4, 8, 16

Title

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

Description

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

Time Frame

baseline and week 4, 12

Title

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

Description

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

Time Frame

week 12 and week 16

Title

System Usability Scale

Description

Time Frame

week 12

Title

Change From Baseline in Dermatology Life Quality Index (DLQI)

Description

Time Frame

baseline and week 12

Title

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

Title

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

Time Frame

week 16

Title

Adverse Device Events (Serious and Non-serious)

Description

Time Frame

week 0, 1, 2, 4, 8, 12, 16

Other Pre-specified Outcome Measures:

Title

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

Description

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

Time Frame

week 4, 12, 16

Title

Adverse Events (Serious and Non-serious)

Time Frame

week 0, 1, 2, 4, 8, 12, 16

Title

Thermal Comfort

Description

Questionaire

Time Frame

week 12

Title

Patient Acceptance of Hyperpigmentation

Description

Questionaire

Time Frame

week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Verena von Felbert, PD, Dr.

Organizational Affiliation

Clinic for Dermatology and Allergology, Medical Faculty of the RWTH Aachen, Germany

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

Citations:

PubMed Identifier

26044167

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.

Results Reference

derived

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Blue Light for Treating Psoriasis Vulgaris

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