Psoriasis VulgarisNCT02004847
Blue Light for Treating Psoriasis Vulgaris
A study testing PSO-CT02 in people with Psoriasis Vulgaris, run by Philips Electronics Nederland BV at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- PSO-CT02
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology and Allergology, Medical faculty of the RWTH Aachen
Aachen, 52074
About this study
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
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.
Read the 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.
- Conditions
- Psoriasis Vulgaris
- Being tested
- PSO-CT02
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSO-CT02Device
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.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity (HI) vs control | Experimental | PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient. Receives: Device: PSO-CT02 |
| Low Intensity (LI) vs control | Experimental | PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient. Receives: Device: PSO-CT02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: baseline and week 12
Secondary outcomes (11)
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)).
Measured: 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)).
Measured: 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)).
Measured: 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:
- = no sign
- = slight
- = moderate
- = marked
- = very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: baseline and week 12
Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)
Measured: 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)
Measured: 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.
Measured: week 0, 1, 2, 4, 8, 12, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Electronics Nederland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Verena von Felbert, PD, Dr., Principal investigator, Clinic for Dermatology and Allergology, Medical Faculty of the RWTH Aachen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004847
- Sponsor's protocol ID
- PsoriasisCT02
- Status last verified
- Nov 2015
- First submitted
- 19 Nov 2013
- Last updated
- 18 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26044167
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02004847
- Acronym / sponsor ID
- PsoriasisCT02
- Conditions
- Psoriasis Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Philips Electronics Nederland BVIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Posted 18 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity (HI) vs control | Experimental | Device: PSO-CT02PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient. |
| Low Intensity (LI) vs control | Experimental | Device: PSO-CT02PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSO-CT02The 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. | Device | High Intensity (HI) vs control, Low Intensity (LI) vs control |
Primary outcome
Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity (HI) Group) as Compared to the Control Area at End of Treatment (Visit 7, Week 12).
Time frame: baseline and week 12
In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale: 0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst)).
11 secondary outcomes
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
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
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
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
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
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
System Usability Scale
Time frame: week 12
Change From Baseline in Dermatology Life Quality Index (DLQI)
Time frame: baseline and week 12
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
Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)
Time frame: week 16
Adverse Device Events (Serious and Non-serious)
Time frame: week 0, 1, 2, 4, 8, 12, 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26044167Pfaff 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Verena von Felbert, PD, Dr. principal investigator
Clinic for Dermatology and Allergology, Medical Faculty of the RWTH Aachen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSO-CT02 in people with Psoriasis Vulgaris, run by Philips Electronics Nederland BV at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02004847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.