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Home UVB phototherapy in psoriasis: Effectiveness, Quality of life and Cost-effectiveness.


- candidate number0
- NTR NumberNTR30
- ISRCTNISRCTN83025173
- Date ISRCTN created13-apr-2005
- date ISRCTN requested12-apr-2005
- Date Registered NTR27-dec-2004
- Secondary IDsN/A 
- Public TitleHome UVB phototherapy in psoriasis: Effectiveness, Quality of life and Cost-effectiveness.
- Scientific TitleHome UVB phototherapy in psoriasis: Effectiveness, Quality of life and Cost-effectiveness.
- ACRONYMPLUTO (National Trial on Home UVB Phototherapy for Psoriasis).
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedPsoriasis
- Inclusion criteria1. 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.
- Exclusion criteria1. Analphabetism;
2. Expected non-compliance;
3. History of malignicy of the skin;
4. Known UVB allergy;
5. Chronic Polymorfic Light Eruption (CPLE);
6. Use of (systemic) medication with known phototoxic or photo-allergic properties;
7. Use of the following systemic medication: Ciclosporin (neoral), Methotrexate, acitretin (neotigason);
8. History of ionising radiation.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2002
- planned closingdate1-apr-2005
- Target number of participants196
- InterventionsRandomisation in two treatment groups:
home UVB phototherapy or UVB phototherapy in the hospital (both therapies are common practice in the Netherlands).
- Primary outcomePASI and SAPASI-scores.
- Secondary outcomeQuality of Life (SF-36, EQ-5D, PDI) and Cost-effectiveness.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. Mayke B.G. Koek
- CONTACT for SCIENTIFIC QUERIESDrs. V. Sigurdsson
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsBMC Med Res Methodol. 2006 Aug 1;6:39.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD5-jul-2005 - 2-jul-2008


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