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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intensity (HI) vs control | Experimental | PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient. |
|
| Low Intensity (LI) vs control | Experimental | PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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)). |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperpigmentation of "Normal Skin Areas" Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | Arbitrary units measured by mexameter. Mexameter readings ranged from 0 to 100. Higher values correspond to higher pigmentation levels. | week 4, 12, 16 |
| Adverse Events (Serious and Non-serious) |
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Verena von Felbert, PD, Dr. | Clinic for Dermatology and Allergology, Medical Faculty of the RWTH Aachen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology and Allergology, Medical faculty of the RWTH Aachen | Aachen | 52074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26044167 | Derived | 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. |
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Two patients were screening failures, so 47 actually started the study.
All patient visits were conducted at the Department of Dermatology and Allergology, RWTH Aachen University Hospital. One hundred and twenty-nine patients were prescreened, 49 patients were screened and 47 enrolled in the study at the time of screening from October 2013 to June 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Intensity (HI) vs. Control | PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient. |
| FG001 | Low Intensity (LI) vs. Control | PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Aanalysis Set (FAS)
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| ID | Title | Description |
|---|---|---|
| BG000 | High Intensity (HI) vs Control | PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient. PSO-CT02: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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)). | Full Analysis set (FAS) | Posted | Mean | Standard Deviation | units on a scale | baseline and week 12 |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Intensity (HI) | PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tinnitus | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Matthias Born | Philips GmbH Innovative Technologies Aachen | +491735321764 | matthias.born@philips.com |
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| baseline and week 4 |
| 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 | 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 |
| 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. | 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 |
| 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
| baseline and week 4, 8, 16 |
| 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. | baseline and week 4, 12 |
| 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. | week 12 and week 16 |
| 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). | week 12 |
| 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. | baseline and week 12 |
| Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI) | patients will be followed for the complete duration of the clinical study for 16 weeks |
| Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI) | week 16 |
| 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. | week 0, 1, 2, 4, 8, 12, 16 |
| week 0, 1, 2, 4, 8, 12, 16 |
| Thermal Comfort | Questionaire | week 12 |
| Patient Acceptance of Hyperpigmentation | Questionaire | week 16 |
| BG001 |
| Low Intensity (LI) vs Control |
PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient. PSO-CT02: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control (HI) | Contralateral untreated control plaque on the same patient. |
|
|
|
| Secondary | 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) | 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)). | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | baseline and week 4 |
|
|
|
|
| Secondary | 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 | 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)). | Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 and 16 | Posted | Mean | Standard Deviation | units on a scale | Week 12 and week 16 |
|
|
|
|
| Secondary | 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. | 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)). | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | units on a scale | baseline and week 4, 12, 16 |
|
|
|
|
| Secondary | 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
| Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | units on a scale | baseline and week 4, 8, 16 |
|
|
|
| Secondary | 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. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | arbitrary units | baseline and week 4, 12 |
|
|
|
| Secondary | 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. | Full Analysis Set (FAS); due to one drop out in each group this number is 23 for HI Group and 22 for LI group at week 12 and 16 | Posted | Mean | Standard Deviation | arbitrary units | week 12 and week 16 |
|
|
|
| Secondary | 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). | Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 for HI group. Only 17 of 22 patients completed the questionaire in the LI group. | Posted | Mean | Standard Deviation | units on a scale | week 12 |
|
|
|
| Secondary | 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. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | units on a scale | baseline and week 12 |
|
|
|
| Secondary | Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI) | Full Analysis Set (FAS); Not all patients requested co-use of vitamin D. Only 17 in HI group and 16 in LI group requested co-use of vitamin D | Posted | Mean | Standard Deviation | days | patients will be followed for the complete duration of the clinical study for 16 weeks |
|
|
|
| Secondary | Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI) | Full Analysis Set (FAS); Not all patients requested co-use of vitamin D. Only 17 in HI group and 16 in LI group requested co-use of vitamin D | Posted | Mean | Standard Deviation | days | week 16 |
|
|
|
| Other Pre-specified | Hyperpigmentation of "Normal Skin Areas" Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | Arbitrary units measured by mexameter. Mexameter readings ranged from 0 to 100. Higher values correspond to higher pigmentation levels. | Safety Set (SAF) | Posted | Mean | Standard Deviation | arbitrary units | week 4, 12, 16 |
|
|
|
| Other Pre-specified | Adverse Events (Serious and Non-serious) | Safety Set (SAF) | Posted | Number | number of participants | week 0, 1, 2, 4, 8, 12, 16 |
|
|
|
| Secondary | 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. | Safety Set (SAF) | Posted | Number | number of participants | week 0, 1, 2, 4, 8, 12, 16 |
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| Other Pre-specified | Thermal Comfort | Questionaire | Full Analysis Set | Posted | Number | percentage of participants | week 12 |
|
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| Other Pre-specified | Patient Acceptance of Hyperpigmentation | Questionaire | Safety set (SAF) | Posted | Number | percentage of participants | week 16 |
|
|
|
| 0 |
| 24 |
| 11 |
| 24 |
| EG001 | Low Intensity (LI) | PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient. | 0 | 23 | 8 | 23 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Herpes virus infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Sinobronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Knee operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
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| week 16 |
|
| t-test, 2 sided |
| 0.0064 |
| 2-Sided |
| No |
| Superiority or Other |
| Statistically analysed were the difference in change from baseline to week 16 of the target plaque compared to the control plaque. | t-test, 2 sided | 0.1020 | 2-Sided | No | Superiority or Other |
| week 8 n=24 (HI) n=23 (LI) |
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| week 16 n=23 (HI) n=22 (LI) |
|
| 12 weeks |
|
| 12 weeks |
|
| 16 weeks |
|
| A little uncomfortable |
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| Just right |
|
| A little comfortable |
|
| Comfortable |
|
| Very comfortable |
|
| Missing |
|
| missing data |
|