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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by UMC Utrecht.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00150930
First received: September 6, 2005
Last updated: November 27, 2006
Last verified: August 2005
  Purpose

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 Intervention Phase
Psoriasis
Device: narrowband UVB phototherapy at home
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Home UVB Phototherapy for Psoriasis: Effectiveness, Quality of Life and Cost-Effectiveness

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • (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 Outcome Measures:
  • Dosimetry (every irradiation)
  • Side-effects (every irradiation)
  • Use medication: whole trial

Estimated Enrollment: 200
Study Start Date: October 2002
Estimated Study Completion Date: March 2005
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00150930     History of Changes
Other Study ID Numbers: 945-02-017, ISRCTN83025173
Study First Received: September 6, 2005
Last Updated: November 27, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
psoriasis
ultraviolet
UVB
phototherapy
home care
narrowband

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 31, 2014