Starting dose of ultraviolet B to treat psoriasis
| ISRCTN | ISRCTN84614024 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84614024 |
| Secondary identifying numbers | NRR N0405128578 |
- Submission date
- 03/12/2009
- Registration date
- 10/12/2009
- Last edited
- 10/11/2010
- 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 Robert Dawe
Scientific
Scientific
Photobiology Unit, Department of Dermatology
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
Study information
| Study design | Randomised 3-arm triple blind parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised comparison of methods of selecting narrow-band ultraviolet B starting dose to treat chronic psoriasis |
| Study objectives | Does the method of selecting narrowband ultraviolet B (NB-UVB) starting dose, whether based upon individual patient minimal erythemal dose (50% or 70%) or not, alter efficacy or adverse effects of narrowband ultraviolet B phototherapy to treat chronic psoriasis? |
| Ethics approval(s) | Tayside local regional ethics committee (LREC) approved in 2003 (ref: 109/03) |
| Health condition(s) or problem(s) studied | Psoriasis; dermatological disease |
| Intervention | Narrowband ultraviolet B phototherapy: administered as routine except for decision on start dose. The method of deciding first narrowband ultraviolet B dose was randomised: 1. Start dose 70% minimal erythemal dose 2. Start dose 50% minimal erythemal dose 3. Start dose skin phototype based Treatments were administered 3-times weekly. Duration of treatment and study follow-up was until clearance or minimal residual activity (MRA). The total number of treatments varied (all groups median 27 treatments, maximum 61 treatments) and duration of attending for treatment was median 10 weeks (maximum 34 weeks). The apparent discrepancy (e.g. 34 weeks corresponding to 61 treatments is because not all patients always attended every week 3-times per week). There was no study follow up phase after completion of treatment course many patients have been followed up longer, but not as part of this study. |
| Intervention type | Other |
| Primary outcome measure | 1. Number of narrowband ultraviolet B treatments to clearance of psoriasis 2. Number of important (uncomfortable or painful) erythema episodes occurring during treatment courses |
| Secondary outcome measures | 1. Change in Psoriasis Disability Index (Finlay AY, Khan GK, Luscombe DK, Salek MS. Validation of Sickness Impact Profile and Psoriasis Disability Index in Psoriasis. Br J Dermatol. Dec 1990;123(6):751-756.) 2. Change in Psoriasis Area and Severity Index Both outcomes above were measured at baseline before the first UVB treatment, the 15th and the last treatment visit. |
| Overall study start date | 15/12/2003 |
| Completion date | 15/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 210 (70 in each arm) |
| Key inclusion criteria | All patients referred for NB-UVB phototherapy for chronic (defined as present for more than one year) psoriasis (as diagnosed by a dermatologist), from our catchment area |
| Key exclusion criteria | 1. Less than 16 years old 2.On systemic immunosuppressant therapy or retinoids within the preceding three months |
| Date of first enrolment | 15/12/2003 |
| Date of final enrolment | 15/10/2007 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Photobiology Unit, Department of Dermatology
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
NHS Tayside (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development
Ninewells Hospital and Medical School
Dundee
DD1 9SY
Scotland
United Kingdom
"ROR" |
https://ror.org/000ywep40 |
|---|
Funders
Funder type
Other
NHS Tayside (UK) - Photobiology Unit Charitable Trust
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/02/2011 | Yes | No |
