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Trial registered on ANZCTR


Registration number
ACTRN12619000145101
Ethics application status
Approved
Date submitted
23/01/2019
Date registered
31/01/2019
Date last updated
31/01/2019
Date data sharing statement initially provided
31/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Do makeup and moisturisers with SPF applied to the face provide coverage from UV radiation in adults?
Scientific title
Do makeup and moisturisers with SPF applied to the face provide coverage from UV radiation in adults using UV cameras?
Secondary ID [1] 296997 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sunburn 310968 0
sun exposure 311292 0
Condition category
Condition code
Public Health 309628 309628 0 0
Health promotion/education
Cancer 309629 309629 0 0
Malignant melanoma
Cancer 309630 309630 0 0
Non melanoma skin cancer
Skin 309631 309631 0 0
Other skin conditions
Injuries and Accidents 309910 309910 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aim:
We aim to assess the coverage of SPF cosmetics for intermittent exposure in indoor workers using UV cameras in 80 people.

Participant Involvement:
Overview - Participants will be asked to have a photo of their face taken using a UV camera in the morning and afternoon. Photos will by taken by the researchers who have required training. Participants will be asked to provide feedback after all photos are taken in an audio-recorded interview. Participants will supply and apply their SPF product as per their usual routine.

Participants will be asked to:
Photo Session 1 (morning – beginning of work day):
• Provide informed consent
• Complete a short survey. The baseline survey collects data on their demographics, skin type and regular sunscreen routines. In the baseline survey, participants are asked to provide information on the type of cosmetic worn on the day, its SPF rating and ingredients. If the participant is unsure of their product details they have the option of taking a photo of the product and emailing it to the study research team.
• Have photos of their face taken using a UV camera. Each photo session will have three photos taken: front, right and left side of face.

Photo Session 2 (afternoon – end of work day):
• Have photos of their face taken using a UV camera. Each photo session will have three photos taken: front, right and left side of face.
• Complete a short survey if they spent any time in the sun throughout the day.
• Participants will be shown the UV images of the morning and afternoon sessions and asked to provide feedback during an audio-recorded interview.

Audio-recorded Interview: Researchers will highlight the areas of the face missed and therefore unprotected from UV. Example questions of the audio-recorded interview include if they are surprised by the coverage, if the product met their expectations, and if they would use the product again. Participants will only be able to view their images after the afternoon session just prior to the audio-recorded interview, not after the morning session. Participants are only shown the photos of their face, and not other participants.

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, using SPF 5+ or higher products on their face, 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.There will be no censor bars used on the images (such as censor bars that cover the eyes). This is to allow the viewer to assess the full coverage around the eye area.

Participants will be supervised by the researchers during the photo sessions and have the option to receive reminder emails/or texts to attend their photo sessions.
Intervention code [1] 313272 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318587 0
Number of indoor office workers with UV protection over 80% of their face assessed using UV camera images
Timepoint [1] 318587 0
UV camera images in the morning and afternoon on the same day
Secondary outcome [1] 365443 0
Acceptability of the use of UV camera images to aid in sun protection coverage on the face.
Timepoint [1] 365443 0
5-10 minute audio-recorded, semi-structured interview, one-on-one immediately after the afternoon photo session. Participants are shown their UV photos, the researcher describes the coverage and asks the participant to provide feedback.

Eligibility
Key inclusion criteria
Persons 18 years of age or older, using SPF 5+ or higher products on their face, no restrictions on skin type or ethnicity, work mostly indoors.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

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
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. This study will assess the most common anatomical regions of the face missed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2019
Actual
Date of last participant enrolment
Anticipated
3/06/2019
Actual
Date of last data collection
Anticipated
3/06/2019
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 301572 0
University
Name [1] 301572 0
Queensland University of Technology
Country [1] 301572 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] 301267 0
None
Name [1] 301267 0
Address [1] 301267 0
Country [1] 301267 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302299 0
Queensland University of Technology University Human Research Ethics Committee [EC00171]
Ethics committee address [1] 302299 0
Ethics committee country [1] 302299 0
Australia
Date submitted for ethics approval [1] 302299 0
02/01/2019
Approval date [1] 302299 0
17/01/2019
Ethics approval number [1] 302299 0
UHREC Reference number: 1800001263

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89746 0
Dr Elke Hacker
Address 89746 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 89746 0
Australia
Phone 89746 0
+61 7 3138 9674
Fax 89746 0
Email 89746 0
[email protected]
Contact person for public queries
Name 89747 0
Elke Hacker
Address 89747 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 89747 0
Australia
Phone 89747 0
+61 7 3138 9674
Fax 89747 0
Email 89747 0
[email protected]
Contact person for scientific queries
Name 89748 0
Elke Hacker
Address 89748 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 89748 0
Australia
Phone 89748 0
+61 7 3138 9674
Fax 89748 0
Email 89748 0
[email protected]

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. There will be no censor bars used on the images (such as censor bars that cover the eyes). This is to allow the viewer to assess the full SPF coverage around the eye area. 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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIAssessing Sunscreen Protection Using UV Photography: Descriptive Study2021https://doi.org/10.2196/24653
N.B. These documents automatically identified may not have been verified by the study sponsor.