PsoriasisPhase 4NCT00150930
Home UVB Phototherapy for Psoriasis: Effectiveness, Quality of Life and Cost-Effectiveness
A Phase 4 study testing narrowband UVB phototherapy at home in people with Psoriasis, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
UVB phototherapy is a commonly used treatment for patients with psoriasis. Generally it is performed in the outpatient department of the hospital. The UVB irradiation itself will normally take only a few minutes, but to receive the irradiation patients have to travel to the outpatient department during working hours 2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- narrowband UVB phototherapy at home
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2002to Mar 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Guttate or plaque psoriasis, clinically eligible for narrowband UVB (TL-01) phototherapy;
- Willing to undergo treatment according to randomisation.
Who cannot join
- No informed consent:
- age below 18 years;
- not willing to accept one of the two treatments offered;
- Practical reasons:
- not able to receive one of the two treatments offered (e.g. lack of space at home / living too far from hospital etc.);
- analphabetism (unable to read the patient-information and the questionnaires, unable to provide written answers and written informed consent);
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- lack of knowledge of the Dutch language;
- not in possession of a telephone.
- Expected non-compliance: lack of understanding what the study / treatment is about, with its potential consequences.
- Medical contra-indications:
- malignancy of the skin in the past / at present;
- known UVB-allergy or chronic polymorphic photodermatosis;
- use (at time of inclusion) of (systemic) medication with known phototoxic or photoallergic properties;
- use (at time of inclusion) of systemic antipsoriatic medication (cyclosporin, methotrexate, neotigason, fumaric acid);
- history of exposure to ionising radiation.
Trial locations and contacts
1 site in 1 country.
About this study
UVB phototherapy is a commonly used treatment for patients with psoriasis. Generally it is performed in the outpatient department of the hospital. The UVB irradiation itself will normally take only a few minutes, but to receive the irradiation patients have to travel to the outpatient department during working hours 2 or 3 times a week. In general it is a relatively time-consuming treatment.
Objective of this study is to assess whether UVB treatment administered in the home is as equally effective as the standard outpatient UVB phototherapy. Quality of life and cost-effectiveness are also studied.
Read the detailed description
Psoriasis is a chronic recurrent skin disorder characterised by erythematosquamous lesions (plaques). Usually the abnormal areas are few, but occasionally the disease is more generalised. Psoriasis can be treated locally by application of creams and ointments, for instance corticosteroids and vitamin D3. For most patients topical therapy will suffice. However, for some patients the area involved is such that topical application is not feasible. Or for others, the skin lesions do not respond anymore to topical treatment. In that case the dermatologist may start irradiation with ultraviolet (UV) light or prescribe systemic medication.
UVB phototherapy is a commonly used treatment for patients with psoriasis. Generally it is performed in the outpatient department of the hospital. The UVB irradiation itself will normally take only a few minutes, but to receive the irradiation patients have to travel to the outpatient department during working hours 2 or 3 times a week. In general it is a relatively time-consuming treatment.
To overcome the drawbacks of UVB treatment in the outpatient clinic, home UVB phototherapy was introduced over 25 years ago. However, the safety and effectiveness of home UVB have been debated ever since. Despite all discussion, the number of dermatologists prescribing home UVB phototherapy to their patients seems to gradually increase. We recently demonstrated that there is no sound evidence that would either support or dissuade from prescribing home UVB phototherapy. Particularly the lack of randomised research is apparent. Therefore, the objective of this study is to assess whether UVB treatment administered in the home is as equally effective as the standard outpatient UVB phototherapy. Quality of life and cost-effectiveness are also studied.
Primary Outcome:
(SA)PASI at inclusion, start of therapy, 23 (20-26) irradiations, end of therapy, and at every 2 months after end of therapy (maximum 1 year) Quality of life scores (EQ-5D, SF-36, PDI) at inclusion, start of therapy, 23 (20-26) irradiations and at end of therapy.
Costs and Cost-Effectiveness will be calculated with a time-horizon of 12 months after inclusion (questionnaires were used at inclusion, start of therapy, 23 (20-26) irradiations, end of therapy, and at every 2 months after end of therapy (maximum 1 year))
Secondary Outcome:
Cumulative dosimetry (every irradiation) Total amounts of and types of side-effects (every irradiation) Concomitant use of medication (during the whole trial, data derived from patients' pharmacists)
- Conditions
- Psoriasis
- Being tested
- narrowband UVB phototherapy at home
- Keywords
- psoriasis, ultraviolet, UVB, phototherapy, home care, narrowband
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
narrowband UVB phototherapy at homeDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
(SA)PASI: whole trial (9x)
Quality of life (EQ-5D, SF-36, PDI): inclusion till end of therapy (3x)
Costs & Cost-Effectiveness: during 12 months from inclusion
Secondary outcomes (3)
Dosimetry (every irradiation)
Side-effects (every irradiation)
Use medication: whole trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startOct 2002
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Vigfús Sigurdsson, MD, PhD, Study chair, UMC UtrechtMayke BG Koek, MD, M.Sc., Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150930
- Sponsor's protocol ID
- 945-02-017
- Other IDs
- ISRCTN83025173
- Status last verified
- Aug 2005
- First submitted
- 6 Sep 2005
- Last updated
- 28 Nov 2006
- Results posted
- No
Publications
Koek MB, Buskens E, Steegmans PH, van Weelden H, Bruijnzeel-Koomen CA, Sigurdsson V. UVB phototherapy in an outpatient setting or at home: a pragmatic randomised single-blind trial designed to settle the discussion. The PLUTO study. BMC Med Res Methodol. 2006 Aug 1;6:39. doi: 10.1186/1471-2288-6-39.
PubMed 16882343Koek MB, Sigurdsson V, van Weelden H, Steegmans PH, Bruijnzeel-Koomen CA, Buskens E. Cost effectiveness of home ultraviolet B phototherapy for psoriasis: economic evaluation of a randomised controlled trial (PLUTO study). BMJ. 2010 Apr 20;340:c1490. doi: 10.1136/bmj.c1490.
PubMed 20406865Koek MB, Buskens E, van Weelden H, Steegmans PH, Bruijnzeel-Koomen CA, Sigurdsson V. Home versus outpatient ultraviolet B phototherapy for mild to severe psoriasis: pragmatic multicentre randomised controlled non-inferiority trial (PLUTO study). BMJ. 2009 May 7;338:b1542. doi: 10.1136/bmj.b1542.
PubMed 19423623
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home UVB Phototherapy for Psoriasis: Effectiveness, Quality of Life and Cost-Effectiveness
- ClinicalTrials.gov ID
- NCT00150930
- Acronym / sponsor ID
- 945-02-017
- Conditions
- Psoriasis
- Keywords
- psoriasis, ultraviolet, UVB, phototherapy, home care, narrowband
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Oct 2002
- Study completion
- Mar 2005
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
UVB phototherapy is a commonly used treatment for patients with psoriasis. Generally it is performed in the outpatient department of the hospital. The UVB irradiation itself will normally take only a few minutes, but to receive the irradiation patients have to travel to the outpatient department during working hours 2 or 3 times a week. In general it is a relatively time-consuming treatment.
Objective of this study is to assess whether UVB treatment administered in the home is as equally effective as the standard outpatient UVB phototherapy. Quality of life and cost-effectiveness are also studied.
Detailed description
Psoriasis is a chronic recurrent skin disorder characterised by erythematosquamous lesions (plaques). Usually the abnormal areas are few, but occasionally the disease is more generalised. Psoriasis can be treated locally by application of creams and ointments, for instance corticosteroids and vitamin D3. For most patients topical therapy will suffice. However, for some patients the area involved is such that topical application is not feasible. Or for others, the skin lesions do not respond anymore to topical treatment. In that case the dermatologist may start irradiation with ultraviolet (UV) light or prescribe systemic medication.
UVB phototherapy is a commonly used treatment for patients with psoriasis. Generally it is performed in the outpatient department of the hospital. The UVB irradiation itself will normally take only a few minutes, but to receive the irradiation patients have to travel to the outpatient department during working hours 2 or 3 times a week. In general it is a relatively time-consuming treatment.
To overcome the drawbacks of UVB treatment in the outpatient clinic, home UVB phototherapy was introduced over 25 years ago. However, the safety and effectiveness of home UVB have been debated ever since. Despite all discussion, the number of dermatologists prescribing home UVB phototherapy to their patients seems to gradually increase. We recently demonstrated that there is no sound evidence that would either support or dissuade from prescribing home UVB phototherapy. Particularly the lack of randomised research is apparent. Therefore, the objective of this study is to assess whether UVB treatment administered in the home is as equally effective as the standard outpatient UVB phototherapy. Quality of life and cost-effectiveness are also studied.
Primary Outcome:
(SA)PASI at inclusion, start of therapy, 23 (20-26) irradiations, end of therapy, and at every 2 months after end of therapy (maximum 1 year) Quality of life scores (EQ-5D, SF-36, PDI) at inclusion, start of therapy, 23 (20-26) irradiations and at end of therapy.
Costs and Cost-Effectiveness will be calculated with a time-horizon of 12 months after inclusion (questionnaires were used at inclusion, start of therapy, 23 (20-26) irradiations, end of therapy, and at every 2 months after end of therapy (maximum 1 year))
Secondary Outcome:
Cumulative dosimetry (every irradiation) Total amounts of and types of side-effects (every irradiation) Concomitant use of medication (during the whole trial, data derived from patients' pharmacists)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Guttate or plaque psoriasis, clinically eligible for narrowband UVB (TL-01) phototherapy;
- Willing to undergo treatment according to randomisation.
Key exclusion criteria (15 listed)
- No informed consent:
- Practical reasons:
- Expected non-compliance: lack of understanding what the study / treatment is about, with its potential consequences.
- Medical contra-indications:
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 |
|---|---|---|
| narrowband UVB phototherapy at home | Device | – |
Primary outcome
(SA)PASI: whole trial (9x)
Quality of life (EQ-5D, SF-36, PDI): inclusion till end of therapy (3x)
Costs & Cost-Effectiveness: during 12 months from inclusion
3 secondary outcomes
Dosimetry (every irradiation)
Side-effects (every irradiation)
Use medication: whole trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2006.
- Results publication: PubMed 16882343Koek MB, Buskens E, Steegmans PH, van Weelden H, Bruijnzeel-Koomen CA, Sigurdsson V. UVB phototherapy in an outpatient setting or at home: a pragmatic randomised single-blind trial designed to settle the discussion. The PLUTO study. BMC Med Res Methodol. 2006 Aug 1;6:39. doi: 10.1186/1471-2288-6-39.
- Derived from this study: PubMed 20406865Koek MB, Sigurdsson V, van Weelden H, Steegmans PH, Bruijnzeel-Koomen CA, Buskens E. Cost effectiveness of home ultraviolet B phototherapy for psoriasis: economic evaluation of a randomised controlled trial (PLUTO study). BMJ. 2010 Apr 20;340:c1490. doi: 10.1136/bmj.c1490.
- Derived from this study: PubMed 19423623Koek MB, Buskens E, van Weelden H, Steegmans PH, Bruijnzeel-Koomen CA, Sigurdsson V. Home versus outpatient ultraviolet B phototherapy for mild to severe psoriasis: pragmatic multicentre randomised controlled non-inferiority trial (PLUTO study). BMJ. 2009 May 7;338:b1542. doi: 10.1136/bmj.b1542.
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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.
Vigfús Sigurdsson, MD, PhD study chair
UMC Utrecht
Mayke BG Koek, MD, M.Sc. principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing narrowband UVB phototherapy at home in people with Psoriasis, run by UMC Utrecht at 1 site in Netherlands.
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 2 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 28 Nov 2006. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
(SA)PASI: whole trial (9x). The study lists 3 primary outcomes in all. 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 NCT00150930, which also lists 3 linked publications.
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 28 Nov 2006.