Biomarkers of ultraviolet radiation exposure

• Register: ISRCTN
• Last refreshed on: 7 November 2022
• Main ID: ISRCTN97738113
• Date of registration: 19/07/2012
• Prospective Registration: No
• Primary sponsor: University of Manchester (UK)
• Public title: Biomarkers of ultraviolet radiation exposure
• Scientific title: Biomarkers of ultraviolet (UVR) exposure: tools for determining the relationship between the benefits and hazards of UVR
• Date of first enrolment: 16/04/2012
• Target sample size: 75
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN97738113
• Study type: Interventional
• Study design: Experimental study (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

England, United Kingdom

Contacts

• Name: Lesley Rhodes

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: Skin; Subtopic: Skin (all Subtopics); Disease: Dermatology
Skin and Connective Tissue Diseases
Dermatology

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

12049

Source(s) of Monetary Support

Cancer Research UK (UK)

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 31/05/2014