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National trial on home ultraviolet B (UVB) phototherapy for psoriasis
DOI 10.1186/ISRCTN83025173
ClinicalTrials.gov identifier NCT00150930
EudraCT number
Public title National trial on home ultraviolet B (UVB) phototherapy for psoriasis
Scientific title Home ultraviolet B (UVB) phototherapy in psoriasis: effectiveness, quality of life and cost-effectiveness
Acronym PLUTO
Serial number at source NTR30
Study hypothesis The aim of this study is to compare home UVB phototherapy with the current outpatient UVB phototherapy for patients with psoriasis.

This objective was specified by the following research questions:
1. Is home UVB phototherapy for patients with psoriasis equally as effective as outpatient UVB phototherapy?
2. Does home UVB phototherapy yield a better quality of life than outpatient UVB phototherapy?
3. Are costs for home UVB phototherapy higher, lower or similar to outpatient UVB phototherapy?
4. Is home UVB phototherapy cost-effective?
Lay summary
Ethics approval The final protocol was approved by the Medical Ethics Committees of all participating hospitals.
Study design Multicentre, randomised, single blinded, active controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Psoriasis
Participants - inclusion criteria 1. Psoriasis patients: plaque or guttata psoriasis
2. Eligible for total-body home UVB phototherapy based on the severity of the psoriatic skin lesions
3. Willing AND capable to participate in both possible treatment arms (treatment at home and in the hospital)
4. Sufficient knowledge of the dutch language
5. Age 18 years or more
6. Does have a telephone
Participants - exclusion criteria 1. Analphabetism
2. Expected non-compliance
3. History of malignancy of the skin
4. Known UVB allergy
5. Chronic polymorphic light eruption (CPLE)
6. Use of (systemic) medication with known phototoxic or photo-allergic properties
7. Use of the following systemic medication: cyclosporin (neoral), methotrexate, acitretin (neotigason)
8. History of ionising radiation
Anticipated start date 01/10/2002
Anticipated end date 01/04/2005
Status of trial Completed
Patient information material
Target number of participants 196
Interventions Randomisation to two treatment groups:
1. Home UVB phototherapy
2. UVB phototherapy in the hospital

Both therapies are common practice in the Netherlands.
Primary outcome measure(s) Psoriasis area and severity index (PASI) and self administered PASI (SAPASI) scores.
Secondary outcome measure(s) 1. Quality of life (36-item short form health survey [SF-36], European quality of life [EQ-5D] instrument, psoriasis disability index [PDI])
2. Cost-effectiveness
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Trial website
Publications 1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16882343
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19423623
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20406865
Contact name Dr  Mayke B.G.  Koek
  Address University Medical Centre Utrecht (UMCU)
Department of Dermatology, HPN G02.124
P.O. Box 85500
  City/town Utrecht
  Zip/Postcode 3508 GA
  Country Netherlands
  Tel +31 (0)30 250 7388
  Email M.B.G.Koek@umcutrecht.nl
Sponsor University Medical Centre Utrecht (UMCU) (Netherlands)
  Address P.O. Box 85500
  City/town Utrecht
  Zip/Postcode 3508 GA
  Country Netherlands
  Sponsor website: http://www.umcutrecht.nl/zorg/
Date applied 13/04/2005
Last edited 23/04/2010
Date ISRCTN assigned 13/04/2005
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