Psoriasis VulgarisNCT02735187
Efficacy and Safety of Blue Light (453 nm) Treatment for Mild Psoriasis Vulgaris Over Three Months Compared to Vitamin D.
A study testing Blue light treatment and Vitamin D in people with Psoriasis Vulgaris, run by Philips Electronics Nederland BV at 1 site in Germany.
Trial summary
Patients will be screened up to 28 days before start of treatment. During the screening visit, the purpose and procedures of the study will be explained to potential patients and informed consent will be obtained. At the baseline visit, all inclusion and exclusion criteria will be re-assessed. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Blue light treatment and Vitamin D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Aug 2016
- 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 74 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 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 and Severity Index (PASI) ≤ 10 and body surface area (BSA) ≤ 10 at screening.
- Presence of two comparable psoriatic plaques suitable to be defined as study areas as follows:
Show all 15Show fewer
- 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 ≥ 11cm (border to border)
- If lesion is too large to be fully covered, partial treatment possible
- Otherwise healthy according to physical examination
- Aged 18 years up to ≤74 years
- Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1per cent per year; e.g. oral contraceptives, intra-uterine device (IUD) or transdermal contraceptive patch)
- Willing to abstain from excessive sun / UV exposure (e.g. sunbath, 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 36Show 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: 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 any of the following conditions present or who have been diagnosed in the past with any of the following conditions on the study areas: skin cancer, severe actinic damage and other precancerous lesions
- Patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer ( i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom-Syndrome) Concomitant medication/treatment in medical history and during the study Required
- Treatment of target and control area with Excipial U10 Lipolotio (Galderma)
- Treatment of control area with Daivonex (Leo Pharma) Allowed
- Topical treatment of non-study areas with Vitamin D or WHO group I-II corticosteroids or mometasone Not allowed Within 3 months prior to baseline
- ustekinumab Within 2 months prior to baseline
- adalimumab, alefacept, infliximab Within 1 month prior to baseline
- Etanercept
- Systemic corticosteroids
- Retinoids
- Immunosuppressants (e.g. methotrexate, ciclosporin, azathioprine, chemotherapeutics)
- oral psoralen with ultraviolet A (PUVA)
- Topical or intranasal/inhalation therapy with potent or very potent (WHO group III-IV) corticosteroids
- Within 2 weeks prior to baseline
- ultraviolet B light (UVB) / ultraviolet A light (UVA)
- Topical therapy with
- WHO group I-II corticosteroids
- Topical retinoids
- Vitamin D analogues
- Topical immunomodulators (e.g. calcineurin inhibitors)
- Anthracen derivatives
- Tar
- Salicylic acid
- Intranasal/inhalation therapy with WHO group I-II corticosteroids At baseline
- Photo-sensitizing medication (e.g. psoralen, tetracycline, nalidixic acid, furosemide, amiodarone, phenotiacine, chinclone, fibrates, hypericumperforatum, arnica, valerian, tar, psoralen, ketoprofen) or colours (e.g. thiazide, toluidine blue, eosin, methylene blue, rose Bengal, acridine)
- Initiation of, or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and angiotensin converting enzyme (ACE) inhibitors)
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, Blinded, Intraindividual Study Evaluating Efficacy and Safety of Blue Light (453 nm) Treatment for Mild Psoriasis Vulgaris Over Three Months Compared to Vitamin D
Patients will be screened up to 28 days before start of treatment. During the screening visit, the purpose and procedures of the study will be explained to potential patients and informed consent will be obtained.
At the baseline visit, all inclusion and exclusion criteria will be re-assessed. Eligible patients will be randomized to treatment of the target area with either 30 minutes (group30) or 15 minutes (group15) blue light at 600 milliwatt per square centimeter (mW/cm²). Additionally, two study areas with similar clinical symptomatology will be determined and will be randomized to blue light treated area and Daivonex (Vitamin D) treated area.
After randomization, patients will be trained on a demonstrator device (no actual treatment to ensure investigator is blinded as to which group the patient is randomized to) as well as the Daivonex cream. After patients have been instructed, treatment of the areas will be applied daily (once per day, 5-7 times / week) at home for a treatment period of 12 weeks. During those 12 weeks, patients will return to the study site for safety and effectiveness assessments at week 2, 4, 8 and week 12. A phone call visit will be performed after one week of treatment to check for any adverse events or problems in handling the device or the cream. The visit at week 12 serves as end of treatment visit. The patients will be followed-up for another 4 weeks. Treatment responses will be photo documented.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Blue light treatment, Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue light treatmentDevice
Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.
Vitamin DDrug
Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
| Study group | Role | What they receive |
|---|---|---|
| group30 | Active comparator | Treatment of the target area with 30 minutes of blue light at 453nm compared to Vitamin D creme Daivonex on contralateral Plaque of same patient. Receives: Device: Blue light treatment; Drug: Vitamin D |
| group15 | Active comparator | Treatment of the target area with 15 minutes of blue light at 453nm compared to Vitamin D creme Daivonex on contralateral Plaque of same patient. Receives: Device: Blue light treatment; Drug: Vitamin D |
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 PSI of the Blue Light Treated Area (Group 30) as Compared to the VitaminD Treated Area (Control) at End of Treatment (Week 12).
The local Psoriasis severity index (LPSI) was adapted from the well known PASI. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas (0-4). A total severity score was calculated as the sum of the three symptom ratings (range 0-12). The measure reported is the change in LPSI at end of treatment versus baseline. A negative change indicates an improvement of the LPSI.
Measured: week 12
Secondary outcomes (5)
Change From Baseline (Visit 2) of the Local PSI of the Blue Light Treated Area (Group 15) as Compared to the VitaminD Treated (Control) Area at End of Treatment (Week 12).
The local Psoriasis severity index (LPSI) was adapted from the well known PASI. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas (0-4 each). A total severity score was calculated as the sum of the three symptom ratings (range 0-12). The measure reported is the change in LPSI at end of treatment versus baseline. A negative change indicates an improvement of the LPSI.
Measured: week 12
Change From Baseline in Patient Self-assessment of Severity of Psoriasis of the Blue Light Treated Area (Group 30) Compared to the VitaminD Treated (Control) Area at Week 12 (VAS Scale).
Patient Rating of severity of Psoriasis Plaques on a 0-10 cm Visual Analogue Scale (VAS) scale. VAS = 0 cm corresponds to no pain,, VAS = 10 cm corresponds to maximal imaginable pain.
Measured: week 12
Change From Baseline in Patient Self-assessment of Severity of Psoriasis of the Blue Light Treated Area (Group 15) Compared to the VitaminD Treated (Control) Area at Week 12 (VAS Scale).
Patient Rating of severity of Psoriasis Plaques on 0-10 cm Visual Analogue Scale (VAS) scale. VAS = 0 corresponds to no symptoms of Psoriasis, VAS = 10 corresponds to most severe symptoms of Psoriasis.
Measured: week 12
Lesional Erythema Measured by Mexameter Measured at End of Treatment.
Lesional erythema was measured objectively with a measurement device (Mexameter). The Mexameter delivers a two digit number for the redness of the skin (range 0-99). 0 = no redness and 99 = maximal redness.
Measured: week 12
Patient Satisfaction (Week 12)
Patient satisfaction will be measured by questionnaire using the System usability score (SUS). The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. The higher the score the better the patient satisfaction the better the outcome. The lower the score the worse the patient satisfaction the worse the outcome.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionAug 2016
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.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 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, Universityclinic of the RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735187
- Sponsor's protocol ID
- Psoriasis-CT03
- Status last verified
- Jan 2019
- First submitted
- 16 Mar 2016
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocenter, Randomized, Blinded, Intraindividual Study Evaluating Efficacy and Safety of Blue Light (453 nm) Treatment for Mild Psoriasis Vulgaris Over Three Months Compared to Vitamin D
- ClinicalTrials.gov ID
- NCT02735187
- Acronym / sponsor ID
- Psoriasis-CT03
- Conditions
- Psoriasis Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Philips Electronics Nederland BVIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Posted 8 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will be screened up to 28 days before start of treatment. During the screening visit, the purpose and procedures of the study will be explained to potential patients and informed consent will be obtained.
At the baseline visit, all inclusion and exclusion criteria will be re-assessed. Eligible patients will be randomized to treatment of the target area with either 30 minutes (group30) or 15 minutes (group15) blue light at 600 milliwatt per square centimeter (mW/cm²). Additionally, two study areas with similar clinical symptomatology will be determined and will be randomized to blue light treated area and Daivonex (Vitamin D) treated area.
After randomization, patients will be trained on a demonstrator device (no actual treatment to ensure investigator is blinded as to which group the patient is randomized to) as well as the Daivonex cream. After patients have been instructed, treatment of the areas will be applied daily (once per day, 5-7 times / week) at home for a treatment period of 12 weeks. During those 12 weeks, patients will return to the study site for safety and effectiveness assessments at week 2, 4, 8 and week 12. A phone call visit will be performed after one week of treatment to check for any adverse events or problems in handling the device or the cream. The visit at week 12 serves as end of treatment visit. The patients will be followed-up for another 4 weeks. Treatment responses will be photo documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group30 | Active comparator | Device: Blue light treatment, Drug: Vitamin DTreatment of the target area with 30 minutes of blue light at 453nm compared to Vitamin D creme Daivonex on contralateral Plaque of same patient. |
| group15 | Active comparator | Device: Blue light treatment, Drug: Vitamin DTreatment of the target area with 15 minutes of blue light at 453nm compared to Vitamin D creme Daivonex on contralateral Plaque of same patient. |
Who may qualify
- Ages
- 18 to 74 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 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 and Severity Index (PASI) ≤ 10 and body surface area (BSA) ≤ 10 at screening.
Key exclusion criteria (36 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 |
|---|---|---|
| Blue light treatmentPhototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. | Device | group15, group30 |
| Vitamin DTreatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex) | Drug | group15, group30 |
Primary outcome
Change From Baseline (Visit 2) of the Local PSI of the Blue Light Treated Area (Group 30) as Compared to the VitaminD Treated Area (Control) at End of Treatment (Week 12).
Time frame: week 12
The local Psoriasis severity index (LPSI) was adapted from the well known PASI. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas (0-4). A total severity score was calculated as the sum of the three symptom ratings (range 0-12). The measure reported is the change in LPSI at end of treatment versus baseline. A negative change indicates an improvement of the LPSI.
5 secondary outcomes
Change From Baseline (Visit 2) of the Local PSI of the Blue Light Treated Area (Group 15) as Compared to the VitaminD Treated (Control) Area at End of Treatment (Week 12).
Time frame: week 12
Change From Baseline in Patient Self-assessment of Severity of Psoriasis of the Blue Light Treated Area (Group 30) Compared to the VitaminD Treated (Control) Area at Week 12 (VAS Scale).
Time frame: week 12
Change From Baseline in Patient Self-assessment of Severity of Psoriasis of the Blue Light Treated Area (Group 15) Compared to the VitaminD Treated (Control) Area at Week 12 (VAS Scale).
Time frame: week 12
Lesional Erythema Measured by Mexameter Measured at End of Treatment.
Time frame: week 12
Patient Satisfaction (Week 12)
Time frame: week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Universityclinic of the RWTH Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue light treatment and Vitamin D 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 36 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 8 Jan 2019. 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 8 Jan 2019). 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 PSI of the Blue Light Treated Area (Group 30) as Compared to the VitaminD Treated Area (Control) at End of Treatment (Week 12). (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2019.