- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02004847
Blue Light for Treating Psoriasis Vulgaris
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 Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aachen, Germany, 52074
- Department of Dermatology and Allergology, Medical faculty of the RWTH Aachen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: High Intensity (HI) vs control
PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient.
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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.
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EXPERIMENTAL: Low Intensity (LI) vs control
PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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)). |
baseline and week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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)). |
baseline and week 4
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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
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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)). |
Week 12 and week 16
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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
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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)). |
baseline and week 4, 12, 16
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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
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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
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baseline and week 4, 8, 16
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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
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Erythema was measured directly after treatment.
Mexameter readings ranged from 0 to 100.
Higher values describe higher erythema levels.
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baseline and week 4, 12
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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
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Erythema was measured directly after treatment.
Mexameter readings ranged from 0 to 100.
Higher values describe higher erythema levels.
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week 12 and week 16
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System Usability Scale
Time Frame: week 12
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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).
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week 12
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Change From Baseline in Dermatology Life Quality Index (DLQI)
Time Frame: baseline and week 12
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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.
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baseline and week 12
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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
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patients will be followed for the complete duration of the clinical study for 16 weeks
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Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)
Time Frame: week 16
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week 16
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Adverse Device Events (Serious and Non-serious)
Time Frame: week 0, 1, 2, 4, 8, 12, 16
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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. |
week 0, 1, 2, 4, 8, 12, 16
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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Arbitrary units measured by mexameter.
Mexameter readings ranged from 0 to 100.
Higher values correspond to higher pigmentation levels.
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week 4, 12, 16
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Adverse Events (Serious and Non-serious)
Time Frame: week 0, 1, 2, 4, 8, 12, 16
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week 0, 1, 2, 4, 8, 12, 16
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Thermal Comfort
Time Frame: week 12
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Questionaire
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week 12
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Patient Acceptance of Hyperpigmentation
Time Frame: week 16
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Questionaire
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week 16
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Verena von Felbert, PD, Dr., Clinic for Dermatology and Allergology, Medical Faculty of the RWTH Aachen, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PsoriasisCT02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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