The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000977178
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
Measuring coverage of low and high sun protection factor (SPF) cosmetics
Scientific title
Measuring coverage of low and high SPF cosmetics on the face in healthy adults
Secondary ID [1] 297561 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sunburn 311793 0
sun exposure 311794 0
Condition category
Condition code
Cancer 310411 310411 0 0
Malignant melanoma
Cancer 310412 310412 0 0
Non melanoma skin cancer
Public Health 310413 310413 0 0
Health promotion/education
Injuries and Accidents 310414 310414 0 0
Burns
Skin 311951 311951 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to measure the difference in coverage between lotions containing SPF 15+ and SPF 50+ using a UV camera.

This study involves one in-person visit to the researchers. Participants will be sent a reminder 24 hours before their visit via email.

Study procedures:
• Complete a brief demographics survey. The baseline survey collects data on their demographics, skin type and regular sunscreen routines.
• Have their face (clean skin) photographed with a UV camera.
• Participants will be randomised to apply SPF 15+ to either the left or right side of their face. Participants apply SPF 50+ to the other side of the face.
• Three images will be taken of the participant’s front, left and right side of their face using a UV camera indoors at IHBI both immediately after and 20 minutes after sunscreen application.
• Participants are asked about their satisfaction with the products in an in-person interview.

Participants apply the sunscreen themselves, as they usually would.


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 or the individuals workplace (such as other QUT buildings) 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, 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] 313792 0
Prevention
Comparator / control treatment
SPF 50+ lotion main comparator
Control group
Dose comparison

Outcomes
Primary outcome [1] 319276 0
Percentage of difference in coverage between SPF 15+ lotion and SPF 50+ lotion as assessed by image analysis software using UV images
Timepoint [1] 319276 0
UV photographs taken both immediately after sunscreen application; 20 minutes after sunscreen application; one visit by participant only.
Secondary outcome [1] 367539 0
Acceptability of the use of UV camera images to aid in sun protection coverage on the face, assessed by 5-10 minute audio-recorded, semi-structured interview, one-on-one Participants are shown their UV photos, the researcher describes the coverage and asks the participant to provide feedback.
Timepoint [1] 367539 0
immediately after the photo session

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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Participants will be randomised to apply SPF 15+ to either the left or right side of their face. Participants apply SPF 50+ to the other side of the face.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
UV camera images will be assessed for sunscreen coverage using image analysis software. The software will analyse the percentage of area on the face covered with sunscreen and percentage of area missed by sunscreen. Descriptive analysis will be used for participant interviews.

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] 302113 0
University
Name [1] 302113 0
Queensland University of Technology
Address [1] 302113 0
60 Musk Avenue, Kelvin Grove, QLD 4059
Country [1] 302113 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] 301945 0
None
Name [1] 301945 0
Address [1] 301945 0
Country [1] 301945 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302792 0
Queensland University of Technology University Human Research Ethics Committee [EC00171]
Ethics committee address [1] 302792 0
60 Musk Avenue, Kelvin Grove, QLD 4059
Ethics committee country [1] 302792 0
Australia
Date submitted for ethics approval [1] 302792 0
10/06/2019
Approval date [1] 302792 0
25/06/2019
Ethics approval number [1] 302792 0
1800001263

Summary
Brief summary
This study is aiming to assess the difference in coverage between moisturisers with SPF 15+ or SPF 50+ content.

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 randomised to apply SPF 15+ moisturiser to either the left or right side of their face. Participants apply SPF 50+ to the other side of the face. Participants' face will be imaged with a UV camera. Participants will be asked about their satisfaction with products in an in-person interview.

It is hoped this research will help to asses the difference in coverage between lotions with high and low SPF content.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91422 0
Dr Elke Hacker
Address 91422 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 91422 0
Australia
Phone 91422 0
+61 7 3138 9674
Fax 91422 0
Email 91422 0
elke.hacker@qut.edu.au
Contact person for public queries
Name 91423 0
Dr Elke Hacker
Address 91423 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 91423 0
Australia
Phone 91423 0
+61 7 3138 9674
Fax 91423 0
Email 91423 0
elke.hacker@qut.edu.au
Contact person for scientific queries
Name 91424 0
Dr Elke Hacker
Address 91424 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 91424 0
Australia
Phone 91424 0
+61 7 3138 9674
Fax 91424 0
Email 91424 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