Starting dose of ultraviolet B to treat psoriasis

ISRCTN	ISRCTN84614024
DOI	https://doi.org/10.1186/ISRCTN84614024
Protocol serial number	NRR N0405128578
Sponsor	NHS Tayside (UK)
Funder	NHS Tayside (UK) - Photobiology Unit Charitable Trust

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

Photobiology Unit, Department of Dermatology
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised 3-arm triple blind parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	1. Number of narrowband ultraviolet B treatments to clearance of psoriasis 2. Number of important (uncomfortable or painful) erythema episodes occurring during treatment courses
Key secondary outcome measure(s)	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.
Completion date	15/10/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	210
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

United Kingdom
Scotland

Study participating centre

Photobiology Unit, Department of Dermatology

Dundee
DD1 9SY
United Kingdom

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	01/02/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes