National trial on home ultraviolet B (UVB) phototherapy for psoriasis
| ISRCTN | ISRCTN83025173 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83025173 |
| ClinicalTrials.gov (NCT) | NCT00150930 |
| Protocol serial number | NTR30 |
| Sponsor | University Medical Centre Utrecht (UMCU) (Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
- Submission date
- 13/04/2005
- Registration date
- 13/04/2005
- Last edited
- 23/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mayke B.G. Koek
Scientific
Scientific
University Medical Centre Utrecht (UMCU)
Department of Dermatology, HPN G02.124
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 250 7388 |
|---|---|
| M.B.G.Koek@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, single blinded, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Home ultraviolet B (UVB) phototherapy in psoriasis: effectiveness, quality of life and cost-effectiveness |
| Study acronym | PLUTO |
| Study objectives | 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(s) | The final protocol was approved by the Medical Ethics Committees of all participating hospitals. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Psoriasis area and severity index (PASI) and self administered PASI (SAPASI) scores. |
| Key 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]) |
| Completion date | 01/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 196 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 01/04/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht (UMCU)
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2006 | Yes | No | |
| Results article | results | 07/05/2009 | Yes | No | |
| Results article | results | 20/04/2010 | Yes | No |
