Condition category
Skin and Connective Tissue Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
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

Trial website

Contact information



Primary contact

Prof Lesley Rhodes


Contact details

Photobiology Unit
Dermatology Centre
Salford Royal NHS Foundation Trust
Stott Lane
M6 8HD
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


Study hypothesis

There is convincing evidence, and widespread agreement that ultraviolet radiation (UVR)-induced DNA damage has a major role in skin carcinogenesis, causally relating damage to an adverse health effect, and making damage products potentially useful biomarkers. For example, there is a high incidence of skin cancer in xeroderma pigmentosum patients, who are deficient in one of the mechanisms of DNA damage repair. Methods for measuring DNA damage are necessarily invasive, requiring skin biopsy or blood samples to be taken, with the exception of a few reports in which urinary levels of damage repair products were assessed. The amount of damage formed may be indicative of the risk associated with exposure. Generally it is the unrepaired damage that is detrimental, and in the simple model the more damage formed, the greater the likelihood of not all of it being repaired. On this basis, the measurement of the products of DNA repair are proportional to the amount of UVR exposure received, the damage formed, plus inform on the likelihood of damage remaining. We propose that 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. Furthermore, they are chemically stable, not subject to artefactual formation during sample workup and are readily detectable following low, biologically relevant exposures. This biomarker qualification project will develop and validate methodology for biomonitoring UVR exposure.

More details can be found at

Ethics approval

University of Manchester Research Ethics Committee approved on the 6th December 2011, ref: 11266

Study design

Experimental study

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Topic: Skin; Subtopic: Skin (all Subtopics); Disease: Dermatology


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



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


Overall trial end date


Reason abandoned


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Photobiology Unit
M6 8HD
United Kingdom

Sponsor information


University of Manchester (UK)

Sponsor details

FMHS Research Office
3.53 Simon Building
M13 9PT
United Kingdom

Sponsor type




Funder type


Funder name

Cancer Research UK (UK)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


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