NCT00150930

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

November 28, 2006

Status Verified

August 1, 2005

First QC Date

September 6, 2005

Last Update Submit

November 27, 2006

Conditions

Psoriasis

Keywords

psoriasisultravioletUVBphototherapyhome carenarrowband

Outcome Measures

Primary Outcomes (3)

  • (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

Interventions

narrowband UVB phototherapy at homeDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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);
  • 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;
  • history of exposure to ionising radiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 16882343RESULT

  • Koek 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.

    PMID: 20406865DERIVED

  • Koek 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.

    PMID: 19423623DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Vigfús Sigurdsson, MD, PhD

    UMC Utrecht

    STUDY CHAIR

  • Mayke BG Koek, MD, M.Sc.

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

October 1, 2002

Study Completion

March 1, 2005

Last Updated

November 28, 2006

Record last verified: 2005-08

Locations

NL(1)