Psoriasis Vulgaris
Conditions
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.
Interventions
DEVICEPSO-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.
Sponsors
Philips Electronics Nederland BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | baseline and week 4, 12 | Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) | 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. |
| 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) | 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. |
| 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) | 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)). |
| 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 | 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)). |
| 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. | 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)). |
| 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 | 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: 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). |
| 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 | week 12 and week 16 | Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels. |
| System Usability Scale | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Thermal Comfort | week 12 | Questionaire |
| Patient Acceptance of Hyperpigmentation | week 16 | Questionaire |
| Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | week 4, 12, 16 | Arbitrary units measured by mexameter. Mexameter readings ranged from 0 to 100. Higher values correspond to higher pigmentation levels. |
| Adverse Events (Serious and Non-serious) | week 0, 1, 2, 4, 8, 12, 16 | — |
Countries
Germany
Participant flow
Recruitment details
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.
Pre-assignment details
Two patients were screening failures, so 47 actually started the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 23 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Low Intensity (LI) vs Control | High Intensity (HI) vs Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 23 Participants | 45 Participants |
| Age, Continuous | 49.09 years STANDARD_DEVIATION 10.68 | 46.54 years STANDARD_DEVIATION 13.8 | 47.79 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment Germany | 23 participants | 24 participants | 47 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 24 | 8 / 23 |
| serious Total, serious adverse events | 0 / 24 | 0 / 23 |
Outcome results
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)).
Time frame: baseline and week 12
Population: Full Analysis set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity (HI) | 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). | -2.38 units on a scale | Standard Deviation 1.53 |
| Control (HI) | 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). | -1.46 units on a scale | Standard Deviation 1.59 |
Comparison: Statistically analysed were the difference in change from baseline to the end of treatment (week 12) of the target plaque compared to the control plaque.p-value: 0.0005t-test, 2 sided
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.
Time frame: week 0, 1, 2, 4, 8, 12, 16
Population: Safety Set (SAF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Intensity (HI) | Adverse Device Events (Serious and Non-serious) | non serious | 0 number of participants |
| High Intensity (HI) | Adverse Device Events (Serious and Non-serious) | serious | 0 number of participants |
| Control (HI) | Adverse Device Events (Serious and Non-serious) | non serious | 0 number of participants |
| Control (HI) | Adverse Device Events (Serious and Non-serious) | serious | 0 number of participants |
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.
Time frame: baseline and week 12
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity (HI) | Change From Baseline in Dermatology Life Quality Index (DLQI) | -0.75 units on a scale | Standard Deviation 2.98 |
| Control (HI) | Change From Baseline in Dermatology Life Quality Index (DLQI) | -0.36 units on a scale | Standard Deviation 4.18 |
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.
Time frame: baseline and week 4, 12
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity (HI) | 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 | 4 weeks | 3.38 arbitrary units | Standard Deviation 13.87 |
| High Intensity (HI) | 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 | 12 weeks | -0.38 arbitrary units | Standard Deviation 11.02 |
| Control (HI) | 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 | 12 weeks | -0.58 arbitrary units | Standard Deviation 11.82 |
| Control (HI) | 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 | 4 weeks | 1.00 arbitrary units | Standard Deviation 13.45 |
| Low Intensity (LI) | 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 | 12 weeks | 5.50 arbitrary units | Standard Deviation 16.66 |
| Low Intensity (LI) | 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 | 4 weeks | 0.13 arbitrary units | Standard Deviation 11.9 |
| Control (LI) | 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 | 4 weeks | 2.87 arbitrary units | Standard Deviation 12 |
| Control (LI) | 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 | 12 weeks | 1.05 arbitrary units | Standard Deviation 9.77 |
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)).
Time frame: baseline and week 4
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity (HI) | 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) | -1.92 units on a scale | Standard Deviation 1.21 |
| Control (HI) | 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) | -1.33 units on a scale | Standard Deviation 1.66 |
Comparison: Statistically analysed were the difference in change from baseline to the end of treatment during the attack period (week 4) of the target plaque compared to the control plaque.p-value: 0.0036t-test, 2 sided
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)).
Time frame: baseline and week 4, 12, 16
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity (HI) | 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. | week 4 | -1.83 units on a scale | Standard Deviation 1.557 |
| High Intensity (HI) | 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. | week 12 | -2.78 units on a scale | Standard Deviation 1.347 |
| High Intensity (HI) | 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. | week 16 | -3.00 units on a scale | Standard Deviation 1.447 |
| Control (HI) | 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. | week 4 | -0.87 units on a scale | Standard Deviation 1.604 |
| Control (HI) | 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. | week 12 | -2.04 units on a scale | Standard Deviation 1.461 |
| Control (HI) | 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. | week 16 | -2.50 units on a scale | Standard Deviation 1.655 |
Comparison: Statistically analysed were the difference in change from baseline to week 4 of the target plaque compared to the control plaque.p-value: 0.014t-test, 2 sided
Comparison: Statistically analysed were the difference in change from baseline to week 12 of the target plaque compared to the control plaque.p-value: 0.0064t-test, 2 sided
Comparison: Statistically analysed were the difference in change from baseline to week 16 of the target plaque compared to the control plaque.p-value: 0.102t-test, 2 sided
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.
Time frame: week 12 and week 16
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity (HI) | 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 | -2.26 arbitrary units | Standard Deviation 14.08 |
| Control (HI) | 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 | 2.00 arbitrary units | Standard Deviation 14.97 |
| Low Intensity (LI) | 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 | -1.64 arbitrary units | Standard Deviation 12.07 |
| Control (LI) | 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 | 3.23 arbitrary units | Standard Deviation 9.97 |
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)).
Time frame: Week 12 and week 16
Population: Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 and 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity (HI) | 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 | -0.22 units on a scale | Standard Deviation 1.313 |
| Control (HI) | 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 | -0.43 units on a scale | Standard Deviation 1.59 |
Comparison: Statistically analysed were the difference in change from end of treatment (week 12, visit 7) to end of follow up (week 16, visit 8) of the target plaque compared to the control plaque.p-value: 0.3075t-test, 2 sided
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 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).
Time frame: baseline and week 4, 8, 16
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity (HI) | 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 | week 4 n=24 (HI) n=23 (LI) | -1.92 units on a scale | Standard Deviation 1.213 |
| High Intensity (HI) | 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 | week 16 n=23 (HI) n=22 (LI) | -2.57 units on a scale | Standard Deviation 1.619 |
| High Intensity (HI) | 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 | week 8 n=24 (HI) n=23 (LI) | -2.25 units on a scale | Standard Deviation 1.359 |
| Control (HI) | 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 | week 4 n=24 (HI) n=23 (LI) | -1.33 units on a scale | Standard Deviation 1.659 |
| Control (HI) | 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 | week 16 n=23 (HI) n=22 (LI) | -1.87 units on a scale | Standard Deviation 1.842 |
| Control (HI) | 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 | week 8 n=24 (HI) n=23 (LI) | -1.50 units on a scale | Standard Deviation 1.719 |
| Low Intensity (LI) | 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 | week 4 n=24 (HI) n=23 (LI) | -1.83 units on a scale | Standard Deviation 1.557 |
| Low Intensity (LI) | 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 | week 8 n=24 (HI) n=23 (LI) | -1.78 units on a scale | Standard Deviation 1.65 |
| Low Intensity (LI) | 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 | week 16 n=23 (HI) n=22 (LI) | -3.00 units on a scale | Standard Deviation 1.447 |
| Control (LI) | 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 | week 4 n=24 (HI) n=23 (LI) | -0.87 units on a scale | Standard Deviation 1.604 |
| Control (LI) | 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 | week 16 n=23 (HI) n=22 (LI) | -2.50 units on a scale | Standard Deviation 1.655 |
| Control (LI) | 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 | week 8 n=24 (HI) n=23 (LI) | -1.30 units on a scale | Standard Deviation 1.46 |
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).
Time frame: week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity (HI) | System Usability Scale | 88.37 units on a scale | Standard Deviation 11.62 |
| Control (HI) | System Usability Scale | 88.53 units on a scale | Standard Deviation 9.02 |
Secondary
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
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity (HI) | Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI) | 46.35 days | Standard Deviation 17.68 |
| Control (HI) | Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI) | 48.25 days | Standard Deviation 26.36 |
Secondary
Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)
Time frame: week 16
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity (HI) | Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI) | 62.65 days | Standard Deviation 23.82 |
| Control (HI) | Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI) | 53.44 days | Standard Deviation 33.66 |
Other Pre-specified
Adverse Events (Serious and Non-serious)
Time frame: week 0, 1, 2, 4, 8, 12, 16
Population: Safety Set (SAF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Intensity (HI) | Adverse Events (Serious and Non-serious) | adverse events | 11 number of participants |
| High Intensity (HI) | Adverse Events (Serious and Non-serious) | serious adverse events | 0 number of participants |
| Control (HI) | Adverse Events (Serious and Non-serious) | adverse events | 8 number of participants |
| Control (HI) | Adverse Events (Serious and Non-serious) | serious adverse events | 0 number of participants |
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.
Time frame: week 4, 12, 16
Population: Safety Set (SAF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity (HI) | Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | 4 weeks | 25.88 arbitrary units | Standard Deviation 6.02 |
| High Intensity (HI) | Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | 16 weeks | 27.17 arbitrary units | Standard Deviation 8.61 |
| High Intensity (HI) | Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | 12 weeks | 27.71 arbitrary units | Standard Deviation 6.75 |
| Control (HI) | Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | 4 weeks | 26.58 arbitrary units | Standard Deviation 6.8 |
| Control (HI) | Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | 16 weeks | 26.39 arbitrary units | Standard Deviation 5.99 |
| Control (HI) | Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | 12 weeks | 25.17 arbitrary units | Standard Deviation 4.65 |
| Low Intensity (LI) | Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | 12 weeks | 24.50 arbitrary units | Standard Deviation 6.81 |
| Low Intensity (LI) | Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | 4 weeks | 25.09 arbitrary units | Standard Deviation 7.86 |
| Low Intensity (LI) | Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | 16 weeks | 25.05 arbitrary units | Standard Deviation 6.45 |
| Control (LI) | Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | 4 weeks | 23.48 arbitrary units | Standard Deviation 5.69 |
| Control (LI) | Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | 16 weeks | 22.95 arbitrary units | Standard Deviation 6.22 |
| Control (LI) | Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter | 12 weeks | 24.18 arbitrary units | Standard Deviation 5.88 |
Other Pre-specified
Patient Acceptance of Hyperpigmentation
Questionaire
Time frame: week 16
Population: Safety set (SAF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Intensity (HI) | Patient Acceptance of Hyperpigmentation | missing data | 8.33 percentage of participants |
| High Intensity (HI) | Patient Acceptance of Hyperpigmentation | Acceptable | 50.00 percentage of participants |
| High Intensity (HI) | Patient Acceptance of Hyperpigmentation | No Hyperpigmentation | 41.67 percentage of participants |
| Control (HI) | Patient Acceptance of Hyperpigmentation | missing data | 4.34 percentage of participants |
| Control (HI) | Patient Acceptance of Hyperpigmentation | Acceptable | 47.83 percentage of participants |
| Control (HI) | Patient Acceptance of Hyperpigmentation | No Hyperpigmentation | 47.83 percentage of participants |
Other Pre-specified
Thermal Comfort
Questionaire
Time frame: week 12
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Intensity (HI) | Thermal Comfort | Very uncomfortable | 0.00 percentage of participants |
| High Intensity (HI) | Thermal Comfort | Uncomfortable | 0.00 percentage of participants |
| High Intensity (HI) | Thermal Comfort | A little uncomfortable | 4.17 percentage of participants |
| High Intensity (HI) | Thermal Comfort | Just right | 25.00 percentage of participants |
| High Intensity (HI) | Thermal Comfort | A little comfortable | 4.17 percentage of participants |
| High Intensity (HI) | Thermal Comfort | Comfortable | 58.33 percentage of participants |
| High Intensity (HI) | Thermal Comfort | Very comfortable | 8.33 percentage of participants |
| High Intensity (HI) | Thermal Comfort | Missing | 0.00 percentage of participants |
| Control (HI) | Thermal Comfort | Missing | 4.35 percentage of participants |
| Control (HI) | Thermal Comfort | Very uncomfortable | 0.00 percentage of participants |
| Control (HI) | Thermal Comfort | A little comfortable | 8.70 percentage of participants |
| Control (HI) | Thermal Comfort | Uncomfortable | 0.00 percentage of participants |
| Control (HI) | Thermal Comfort | Very comfortable | 0.00 percentage of participants |
| Control (HI) | Thermal Comfort | A little uncomfortable | 8.70 percentage of participants |
| Control (HI) | Thermal Comfort | Comfortable | 47.83 percentage of participants |
| Control (HI) | Thermal Comfort | Just right | 30.43 percentage of participants |