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Trial registered on ANZCTR


Registration number
ACTRN12619000212156
Ethics application status
Approved
Date submitted
23/01/2019
Date registered
13/02/2019
Date last updated
17/04/2019
Date data sharing statement initially provided
13/02/2019
Date results information initially provided
17/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the biological responses to sun exposure in healthy adults
Scientific title
Understanding the biological responses and cellular damage after sun exposure in healthy adults
Secondary ID [1] 296674 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sunburn 310516 0
sun exposure 310517 0
Condition category
Condition code
Cancer 309230 309230 0 0
Malignant melanoma
Cancer 309231 309231 0 0
Non melanoma skin cancer
Skin 309908 309908 0 0
Other skin conditions
Injuries and Accidents 309909 309909 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Overview:
This non-randomised, feasibility study aims to examine the minimum dose of solar exposure required to cause cellular damage and induction of repair pathways. Five adult volunteers aged over 18 years will receive graded sub-erythemal UV doses on their lower back under UV Index 3 (intervention) and skin biopsies will be collected 24 hours post UV exposure to analyse the level of cellular damage. Each UV dosage site is 0.9cm2. A control site will also be biopsied to examine non-exposed UV skin (total 5 biopsies across the study).

Participant involvement would include two visits to QUT, Kelvin Grove:
Visit 1:
• Filling in a survey form asking about your type of skin, your medical history and sun exposure behaviour.
• Collection of a saliva sample
• One 1mm punch biopsy of a non-UVR exposed site on the lower back by a registered medical practitioner.
• One 1mm punch biopsy immediately following UV exposure on your lower back by a registered medical practitioner.
• Exposing a row of five square areas of skin on the back (each with an area of 0.9cm2) to a low dose of ultraviolet light (similar to natural sunlight). The exposure will be similar to approximately 15, 30, 40 minutes in the sun before 7am in Brisbane during summer just enough to cause faint redness- to determine how long your skin takes to redden. This is called your Minimal Erythemal Dose (MED). This exposure is less than 1 MED. This is a 1.5 hour visit.

Visit 2:
• On a subsequent visit the next day participants will have 3 skin biopsies on the lower back that was exposed to UV the previous day by a registered medical practitioner. Each biopsy will be only 1mm diameter and will be taken under local anaesthetic. This is a 1 hour visit.

Participants will be provided with an aftercare leaflet, and advised to contact the study team should they have any concerns after the procedures.

Participants are supervised by researchers during the visits and sent reminder emails/or texts by the research team to remind them of their appointments.
Intervention code [1] 312985 0
Diagnosis / Prognosis
Comparator / control treatment
One control site will be biopsied (1mm punch biopsy) on each participant's lower back to examine non-exposed UV skin.
Control group
Active

Outcomes
Primary outcome [1] 308197 0
To test if a 1mm skin biopsy will provide sufficient material to undertake immunohistochemistry and next gen transcriptome protocols.
Timepoint [1] 308197 0
Skin biopsies will be collected 24 hours post UV exposure to analyse the level of cellular damage
Secondary outcome [1] 354214 0
To determine if low dose UVA irradiation can cause skin damage, which is detectable by immunohistochemistry and next gen transcriptome protocols.
Timepoint [1] 354214 0
Skin biopsies will be collected 24 hours post UV exposure to analyse the level of cellular damage

Eligibility
Key inclusion criteria
healthy adults 18 years of age or older, skin type 1-3 fair skin
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals are excluded from participating if they have a history of allergy or adverse reactions to local anaesthetics or any related drug. Participants must not be currently taking medications that induce photosensitivity (you are sensitive to light) or known or suspected to reduce, inflammation immunity or healing (e.g. corticosteroids). Participants must not be on blood thinning medication. Participants are also excluded if they are pregnant, have a history of skin cancer, keloid scarring, heart disease, liver disease, kidney disease, diabetes of any type, or any significant gastrointestinal disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants receive both 4 x intervention and 1 x control biopsies (total 5 biopsies across the study). All participants receive the same conditions.

Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 24868 0
4059 - Kelvin Grove

Funding & Sponsors
Funding source category [1] 301253 0
University
Name [1] 301253 0
Queensland University of Technology
Address [1] 301253 0
60 Musk Avenue, Kelvin Grove, QLD 4059
Country [1] 301253 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
60 Musk Avenue, Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 300888 0
None
Name [1] 300888 0
Address [1] 300888 0
Country [1] 300888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301994 0
Queensland University of Technology University Human Research Ethics Committee [EC00171]
Ethics committee address [1] 301994 0
60 Musk Avenue, Kelvin Grove, QLD 4059
Ethics committee country [1] 301994 0
Australia
Date submitted for ethics approval [1] 301994 0
15/11/2018
Approval date [1] 301994 0
21/01/2019
Ethics approval number [1] 301994 0
1800001130

Summary
Brief summary
This study is aiming to examine the minimum dose of solar exposure required to cause cellular damage and induction of repair pathways.

Who is it for?
You may be eligible for this study if you are aged 18 years of age or older with skin type 1-3 fair skin.

Study details
Participants will receive graded sub-erythemal UV doses on their back equal to sunlight in Brisbane during summer at 7 am for 15, 30 and 40 minutes and skin biopsies will be collected 24 hours post UV exposure to analyse the level of cellular damage. A control site will also be biopsied to examine non-exposed UV skin.

It is hoped this research will help to assess the current UV exposure guidelines and whether the suggested dose limit is safe or not.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88790 0
Dr Elke Hacker
Address 88790 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 88790 0
Australia
Phone 88790 0
+61 7 3138 9674
Fax 88790 0
Email 88790 0
elke.hacker@qut.edu.au
Contact person for public queries
Name 88791 0
Dr Elke Hacker
Address 88791 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 88791 0
Australia
Phone 88791 0
+61 7 3138 9674
Fax 88791 0
Email 88791 0
elke.hacker@qut.edu.au
Contact person for scientific queries
Name 88792 0
Dr Elke Hacker
Address 88792 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 88792 0
Australia
Phone 88792 0
+61 7 3138 9674
Fax 88792 0
Email 88792 0
elke.hacker@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
provided upon request
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary