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Home UVB Phototherapy for Psoriasis: Effectiveness, Quality of Life and Cost-Effectiveness

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ClinicalTrials.gov Identifier: NCT00150930
Recruitment Status : Unknown
Verified August 2005 by UMC Utrecht.
Recruitment status was:  Active, not recruiting
First Posted : September 8, 2005
Last Update Posted : November 28, 2006
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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 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.


Condition or disease Intervention/treatment Phase
Psoriasis Device: narrowband UVB phototherapy at home Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Home UVB Phototherapy for Psoriasis: Effectiveness, Quality of Life and Cost-Effectiveness
Study Start Date : October 2002
Estimated Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. (SA)PASI: whole trial (9x)
  2. Quality of life (EQ-5D, SF-36, PDI): inclusion till end of therapy (3x)
  3. Costs & Cost-Effectiveness: during 12 months from inclusion

Secondary Outcome Measures :
  1. Dosimetry (every irradiation)
  2. Side-effects (every irradiation)
  3. Use medication: whole trial

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Guttate or plaque psoriasis, clinically eligible for narrowband UVB (TL-01) phototherapy;
  2. Willing to undergo treatment according to randomisation.

Exclusion criteria:

  1. No informed consent:

    • age below 18 years;
    • not willing to accept one of the two treatments offered;
  2. 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);
    • lack of knowledge of the Dutch language;
    • not in possession of a telephone.
  3. Expected non-compliance: lack of understanding what the study / treatment is about, with its potential consequences.
  4. 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150930


Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Chair: Vigfús Sigurdsson, MD, PhD UMC Utrecht
Principal Investigator: Mayke BG Koek, MD, M.Sc. UMC Utrecht
More Information