Condition category
Skin and Connective Tissue Diseases
Date applied
03/12/2009
Date assigned
10/12/2009
Last edited
10/11/2010
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 Robert Dawe

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NRR N0405128578

Study information

Scientific title

A randomised comparison of methods of selecting narrow-band ultraviolet B starting dose to treat chronic psoriasis

Acronym

Study hypothesis

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

Tayside local regional ethics committee (LREC) approved in 2003 (ref: 109/03)

Study design

Randomised 3-arm triple blind parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/12/2003

Overall trial end date

15/10/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

210 (70 in each arm)

Participant exclusion criteria

1. Less than 16 years old
2.On systemic immunosuppressant therapy or retinoids within the preceding three months

Recruitment start date

15/12/2003

Recruitment end date

15/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Photobiology Unit, Department of Dermatology
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

NHS Tayside (UK)

Sponsor details

Research & Development
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

NHS Tayside (UK) - Photobiology Unit Charitable Trust

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

Dawe RS, Cameron H, Yule S, Ibbotson SH, Ferguson J. Does method of selecting starting dose affect efficacy of narrow-band ultraviolet B phototherapy for psoriasis? J Invest Dermatol. 2008; 128: 2554 [Abstract from presentation at International Dermato-epidemiology Association Congress, Nottingham, UK, 2008].

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20956635

Publication citations

  1. Results

    Dawe RS, Cameron HM, Yule S, Ibbotson SH, Moseley HH, Ferguson J, A randomized comparison of methods of selecting narrowband UV-B starting dose to treat chronic psoriasis., Arch Dermatol, 2011, 147, 2, 168-174, doi: 10.1001/archdermatol.2010.286.

Additional files

Editorial Notes