Condition category
Skin and Connective Tissue Diseases
Date applied
13/04/2005
Date assigned
13/04/2005
Last edited
23/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mayke B.G. Koek

ORCID ID

Contact details

University Medical Centre Utrecht (UMCU)
Department of Dermatology
HPN G02.124
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 7388
M.B.G.Koek@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00150930

Protocol/serial number

NTR30

Study information

Scientific title

Home ultraviolet B (UVB) phototherapy in psoriasis: effectiveness, quality of life and cost-effectiveness

Acronym

PLUTO

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?

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Psoriasis

Intervention

Randomisation to two treatment groups:
1. Home UVB phototherapy
2. UVB phototherapy in the hospital

Both therapies are common practice in the Netherlands.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Psoriasis area and severity index (PASI) and self administered PASI (SAPASI) scores.

Secondary outcome measures

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

Overall trial start date

01/10/2002

Overall trial end date

01/04/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

196

Participant 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

Recruitment start date

01/10/2002

Recruitment end date

01/04/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht (UMCU)
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    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, 6, 39, doi: 10.1186/1471-2288-6-39.

  2. Results

    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, 338, b1542.

  3. Results

    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, 340, c1490.

Additional files

Editorial Notes