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Trial registered on ANZCTR


Registration number
ACTRN12619000975190
Ethics application status
Approved
Date submitted
25/06/2019
Date registered
9/07/2019
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Using a ultraviolet (UV) camera to determine sunscreen concentration
Scientific title
Using a ultraviolet (UV) Camera to determine sunscreen concentration in healthy adults
Secondary ID [1] 297559 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sunburn 311790 0
sun exposure 311791 0
Condition category
Condition code
Public Health 310405 310405 0 0
Health promotion/education
Cancer 310406 310406 0 0
Malignant melanoma
Cancer 310407 310407 0 0
Non melanoma skin cancer
Skin 310408 310408 0 0
Other skin conditions
Injuries and Accidents 310409 310409 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aim: To validate the UV camera as a tool to measure sunscreen thickness and adequate sunscreen application.
This study involves one in-person visit to the researchers. Participants will be sent a reminder 24 hours before their visit via email.
Participant Involvement:
• Participants will complete a brief demographic survey. The baseline survey collects data on their demographics, skin type and regular sunscreen routines.
• Participants will be asked to ensure their face and arms are clean of any products. The researcher will take one image of the participants' face and an image of each arm using a UV camera to check they do not have any SPF products applied to their face or arms already. Facial wipes provided by the research team.
• The researcher will then measure out 3 x rectangles on the participants' face (forehead, left and right cheek) measuring 4cm x 2.5cm each. The researcher will then measure out 3 x rectangles measuring 4cm x 2.5cm on each arm. The researcher will apply by random assignment moisturiser with SPF 15+ or 50+ to the participants face and arms within the rectangles using gloves applied at 2mg/cm, 0.4mg/cm and 1mg/cm.
• UV images will be taken i) immediately after sunscreen application and ii) 20 minutes after sunscreen application (to ensure sunscreen is absorbed into skin in line with product instructions) of the participant’s front, left and right side of their face and an image of each arm using a UV camera indoors at the Institute of Health and Biomedical Innovation (IHBI), Kelvin Grove, Brisbane.
• The researchers will swab each of the sunscreen rectangle areas on the participants' face and arms to measure the moisturiser with SPF content thickness.

The researchers will supply and apply the sunscreen to the participants face and arms using a template.

UV Camera - The UV camera is designed to image ultraviolet light. As a result, skin with sunscreen on it will appear darker onscreen than skin that's been missed, or that requires a reapplication. The more sunscreen that is present, the darker the skin will look. The photography session is based inside at IHBI using a UVA light Lamp, it uses UV LED which is tested to be safe by the International Electrotechnical Commission. It does not emit UVB, the chief cause of skin reddening and sunburn. It is safe to use on eyes. As an extra precaution, participants will be asked to sit to have their photo taken and asked to close their eyes, then the UV light will be turned on. Participants will not look at the UV light.

Study population:
Persons 18 years of age or older, no restrictions on skin type or ethnicity, general population who work mostly indoors.

Image Consent
Participants are asked to provide separate consent for their use of images in publications and presentations. This is optional, and individuals may still participate in the study if they chose not to provide consent for use of images.
Intervention code [1] 313789 0
Prevention
Comparator / control treatment
sunscreen concentration: 2mg/cm - main comparator
compared to sunscreen concentration: 0.4mg/cm and 1mg/cm and comparator swabs.
Control group
Dose comparison

Outcomes
Primary outcome [1] 319274 0
To determine how the different concentrations (2mg/cm, 0.4mg/cm and 1mg/cm) of SPF products appear in UV images using image analysis software
Timepoint [1] 319274 0
immediately after sunscreen application, 20 minutes after sunscreen application,
Secondary outcome [1] 367537 0
Nil
Timepoint [1] 367537 0
Nil

Eligibility
Key inclusion criteria
Persons 18 years of age or older, work mostly indoors
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergy to sunscreen

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Image analysis software (Volocity, PerkinElmer) will be used to analyse the image data and determine the pixel darkness for each concentration measure. This will generate thresholds for sufficient coverage (2mg/cm), moderate coverage (1mg/cm) and low coverage 0.4mg/cm.

Recruitment
Recruitment status
Not yet recruiting
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

Funding & Sponsors
Funding source category [1] 302111 0
University
Name [1] 302111 0
Queensland University of Technology
Address [1] 302111 0
60 Musk Avenue, Kelvin Grove, QLD 4059
Country [1] 302111 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] 301943 0
None
Name [1] 301943 0
Address [1] 301943 0
Country [1] 301943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302790 0
Queensland University of Technology University Human Research Ethics Committee [EC00171]
Ethics committee address [1] 302790 0
60 Musk Avenue, Kelvin Grove, QLD 4059
Ethics committee country [1] 302790 0
Australia
Date submitted for ethics approval [1] 302790 0
13/05/2019
Approval date [1] 302790 0
25/06/2019
Ethics approval number [1] 302790 0
1800001263

Summary
Brief summary
This study is aiming to validate UV cameras as a tool to measure sunscreen thickness and adequate sunscreen application.

Who is it for?
You may be eligible for this study if you are aged 18 years of age or older, and work mostly indoors. Participants are excluded if they are allergic to sunscreen.

Study details
Participants will be asked to have a photo of their face and each arm taken using a UV camera after having sunscreen applied to their face and arms by the study researchers. The researchers will supply the sunscreen.

It is hoped this research will help to validate the use of UV cameras to assess sunscreen coverage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91414 0
Dr Elke Hacker
Address 91414 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 91414 0
Australia
Phone 91414 0
+61 7 3138 9674
Fax 91414 0
Email 91414 0
elke.hacker@qut.edu.au
Contact person for public queries
Name 91415 0
Dr Elke Hacker
Address 91415 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 91415 0
Australia
Phone 91415 0
+61 7 3138 9674
Fax 91415 0
Email 91415 0
elke.hacker@qut.edu.au
Contact person for scientific queries
Name 91416 0
Dr Elke Hacker
Address 91416 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 91416 0
Australia
Phone 91416 0
+61 7 3138 9674
Fax 91416 0
Email 91416 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
Participants will be identifiable from their UV images. Due to privacy reasons, only the study team will have access to data collected in this project.
What supporting documents are/will be available?
No other documents available
Summary results
No Results