|
Welcome
|
|
18 May 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ ...Back to search results ] | [ Print-friendly version ] |
| National trial on home ultraviolet B (UVB) phototherapy for psoriasis |
| ISRCTN | ISRCTN83025173 |
| 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 |
| 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 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
