Condition category
Skin and Connective Tissue Diseases
Date applied
19/07/2012
Date assigned
19/07/2012
Last edited
06/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Sunshine has both positive and negative effects on health. Humans require sunlight to manufacture vitamin D in the skin however too much sun exposure can cause DNA damage, photo aging and skin cancer. Products of DNA damage repair are excreted in urine making them potentially useful indicators of sunlight exposure and hence risk of skin cancer. This study aims to validate DNA damage in urine as a marker of ultraviolet rays (UVR)-induced skin DNA damage. We will also assess the applicability of urinary DNA damage to assessment of the risk (DNA damage) versus benefit (vitamin D production) of UVR exposure.

Who can participate?
This study will involve healthy male and female adults of all skin types, aged 18-45 years from Greater Manchester.

What does the study involve?
Subjects will first have their sunburn threshold determined then will receive a single, whole body (exposing 35% skin surface area) exposure below this threshold, mimicking a short exposure to sunlight on a summer’s day. Subjects will then collect their urine for five days which will be tested for products of DNA damage. In the second part of the study, subjects will receive four increasing doses of UVR (all below their sunburn threshold), separated by 1 month. Urine and skin biopsy samples will be taken before and after exposure to examine for DNA damage. In addition, blood samples will be taken before and after exposure for vitamin D analysis.

What are the possible benefits and risks of participating?
This study will not provide direct benefit to research participants. However, if any participant taking part is found to have vitamin D levels defined as deficient, their GP will be notified in order that appropriate treatment/advice may be given. Following UVR exposure for sunburn threshold testing, transient redness will be experienced on the exposed area. Tanning of the skin may occur in areas where UVR has been applied. Slight discomfort or bruising may be experienced during blood sampling but this is minimised by using experienced venepuncture practitioners. Skin biopsies on the buttocks may result in small permanent scars.

Where is the study run from?
Photobiology Unit, Salford Royal NHS Foundation Trust.

When is the study starting and how long is it expected to run for?
This study will run from June 2012 for 30 months.

Who is funding the study?
Cancer Research UK

Who is the main contact?
Jessica Edwards, Research Associate Jessica.edwards@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lesley Rhodes

ORCID ID

http://orcid.org/0000-0002-9107-6654

Contact details

Photobiology Unit
Dermatology Centre
Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom
+44 161 306 6000
lesley.e.rhodes@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12049

Study information

Scientific title

Biomarkers of ultraviolet (UVR) exposure: tools for determining the relationship between the benefits and hazards of UVR

Acronym

Study hypothesis

Urinary DNA damage repair products are ideal biomarkers of UVR exposure and are potential intermediate biomarkers for skin cancer risk, as their presence in urine is related to both UVR exposure and DNA repair.

Ethics approval

University of Manchester Research Ethics Committee, 06/12/2011, ref: 11266

Study design

Experimental study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Diagnostic

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

Participants exposing approximately 35% skin surface area will receive a single, whole body exposure to UVR of 0.8 MED. Urine collected over the following 5 days will be analysed to determine the time of maximal DNA damage product concentration. Participants will then receive 4 increasing whole body doses of UVR (0.2-0.8 MED) each separated by 1 month. DNA damage in urine collected at the optimal time point and in skin biopsies taken immediately and 48 h after exposure will be compared to that in samples taken pre-exposure. Serum 25(OH)D will also be assessed.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Urinary DNA damage; Timepoint(s): Up to 14 days post exposure

Secondary outcome measures

1. Time of maximal DNA damage product concentration in urine following acute UVR exposure
2. Minimum dose of UVR required to produce detectable levels of DNA damage in urine
3. Level of DNA damage in skin biopsy sections following acute UVR
4. Concentration of serum 25(OH)D following acute UVR exposure

Overall trial start date

16/04/2012

Overall trial end date

31/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy, ambulant human volunteers
2. Aged 18-45 years
3. Sun reactive skin types I-VI
4. Non smokers
5. Body mass index (BMI) of less than 30

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 75; UK Sample Size: 75

Participant exclusion criteria

1. History of skin cancer or photosensitivity disorder
2. Taking photoactive medication
3. Sunbathing or sunbed use in the past 3 months
4. Taking dietary supplements containing vitamin D or antioxidants

Recruitment start date

16/04/2012

Recruitment end date

31/05/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Photobiology Unit
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

FMHS Research Office
3.53 Simon Building
Manchester
M13 9PT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

06/12/2016: No publications found in PubMed, verifying study status with principal investigator.