Condition category
Skin and Connective Tissue Diseases
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
09/05/2016
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 Sophie Weatherhead

ORCID ID

Contact details

Newcastle University
Dermatology
2nd Floor William Leech Building
Medical School
Newcastle
NE2 4HH
United Kingdom

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 measures

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

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

http://www.newcastle-hospitals.org.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/05/2016: No publications found, verifying study status with principal investigator.