Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
5623; 079504
Study information
Scientific title
Investigation of the effects and mechanisms of action of different wavelengths of ultraviolet B (UVB) radiation in the treatment of psoriasis: a single centre non-randomised treatment trial
Acronym
MECH-UVB-PSOR
Study hypothesis
To test the hypothesis that keratinocyte apoptosis is an important mechanism of action of ultraviolet B (UVB) phototherapy in the clearance of psoriasis, and to investigate the correlation between effectiveness of different wavelengths of UV and apoptotic response in the clearance of psoriasis.
Ethics approval
County Durham and Tees Valley (1) REC, ref: 06/Q1003/78
Study design
Single centre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Skin; Subtopic: Skin (all Subtopics); Disease: Dermatology
Intervention
Compare the apoptotic effect of different wavelengths of UVB in psoriatic epidermis in vivo.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Whether the number of apoptotic cells seen within the epidermis is sufficient to allow plaque remodelling. Measured up to 48 hours (4 hours, 8 hours, 12 hours,15 hours, 18 hours, 24 hours, and 48 hours).
Secondary outcome measures
1. Effect of skin type
2. UV dose
3. Age and gender
Measured up to 48 hours (4 hours, 8 hours, 12 hours,15 hours, 18 hours, 24 hours, and 48 hours).
Overall trial start date
01/10/2006
Overall trial end date
30/04/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years and over, with no sex specific criteria
2. All patients who are prescribed routine UVB (TL01) for their psoriasis at our centre
3. Give informed consent to participate
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 121
Participant exclusion criteria
1. Aged under 18 years
2. Systemic immunosupression within 3 months
3. UVB exposure to lower back within 3 months of recruitment
4. Topical treatments other than emollients for 2 weeks
Recruitment start date
01/10/2006
Recruitment end date
30/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle University
Newcastle
NE2 4HH
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 079504)
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
Basic results (scientific)
Publication list