Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001572358
Ethics application status
Approved
Date submitted
10/11/2017
Date registered
22/11/2017
Date last updated
7/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Do commercially available sunscreen indicators assist in sun protection in healthy adults?
Scientific title
A clinical trial to ascertain if sunscreen indicators facilitate sun protection behaviour in healthy adults
Secondary ID [1] 293336 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sunburn 305429 0
sun exposure 305430 0
Condition category
Condition code
Skin 304707 304707 0 0
Other skin conditions
Public Health 304755 304755 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this research project is to test commercially available UV indicating stickers to ascertain if these stickers can facilitate sun protection behaviour. UV Indicating stickers change colour with UV light, letting you know how effective your sunscreen is (applied over the top). The sticker changes colour once your sunscreen has worn off, indicating you are no longer protected from the sun. To assess this product we are conducting a study at the Ashes Cricket Test at the Brisbane Cricket Ground, commonly known as the Gabba, which is a major sports stadium in Brisbane. The event is being held November 23rd – November 27th 2017. The researchers will be at the venue entry and will ask interested members of the public to consent to participate before they enter the stadium.
Intervention group: On Day 2-5 (November 24-27th 2017) of the event researchers will be at the venue entry and will ask interested members of the public to consent to participate before they enter the stadium (n=900). Participants must be attending the Ashes Cricket test as a spectator to participate. Consent will involve handing out the information sheet to interested participants queuing to enter the stadium. We will allow adequate time for participants to read the information sheet, ask questions and discuss elements of the project. Participants willing to participate in both control and intervention groups will be asked to complete a baseline questionnaire at the time of enrolment. The participants consent to participate is required at the commencement of the baseline survey (tick box agreement after the information sheet) and a final submission will be considered an indication of the participants consent. Participants will have the option of completing the baseline survey electronically or using a paper-based version provided on clipboards and including the participant information sheet and baseline survey. If they choose to complete it electronically they will be provided with the survey URL to complete on their own mobile device. The survey URL also includes the participant information and consent process.
The baseline survey needs to be completed before they are provided with the sunscreen and sticker. Once the baseline survey is complete, participants will be provided with free sunscreen (tube 35ml, 50 + SPF Cancer Council Brand) and 1 UV indicator sticker.
Participants will be asked to apply the sticker to a body part exposed to the sun and apply sunscreen over the top of the sticker in-line with the product instructions whilst at the cricket venue. Participants will be asked to go about their normal activities, and they can determine themselves where they apply sunscreen on the rest of their body. Participants also have the option of using their own sunscreen. The sticker lasts for up to one day, and they will be asked to wear it for the duration of time they are at the cricket.
Participants will be emailed a survey link to their email (collected in the baseline survey) to complete an evaluation survey (10 minutes) at the end of the day. This survey will ask about participants sun protection practices whilst using the sticker (i.e if they applied sunscreen, if they reapplied, and sunscreen preferences). Intervention adherence is assessed via self-report in the evaluation survey.
Attendees who attend multiple days at the Cricket will only be invited to participate in the study once.
Upon completion of the evaluation survey, participants will go into the draw to win one of 5x $200 Coles/Myer gift vouchers.
Intervention code [1] 299590 0
Prevention
Comparator / control treatment
Control group: A comparative control group (n=100) will be provided with sunscreen only (no stickers) on Day 1 of the event and asked to complete a brief baseline Questionnaire (3 minutes) after they provide consent and during the enrolment process. (Same consent process as the intervention group defined above). Participants will be asked to go about their normal activity, and can choose to apply the sunscreen anywhere on their body at their discretion (or not at all). Day 1 is Thursday 23rd November. At the completion of Day 1 an online evaluation survey (5-10 minutes) will be emailed to participants for completion. Participants will have one week post using the free sunscreen to complete the evaluation survey. This survey will ask about participants sun protection practices (i.e if they applied sunscreen, if they reapplied, and sunscreen preferences).
Upon completion of the evaluation survey, control participants will also go into the same draw to win one of 5x $200 Coles/Myer gift vouchers.
Control group
Active

Outcomes
Primary outcome [1] 303918 0
Satisfaction with the UV stickers. This evaluation survey is designed specifically for this study.
Timepoint [1] 303918 0
Online self-reported evaluation survey completed within 7 days of use.
Secondary outcome [1] 340457 0
Sunburn in the intervention versus control group. This is a yes/no outcome. This survey is designed specifically for this study.
Timepoint [1] 340457 0
Self-reported sunburn on the day of enrolment self-reported in online evaluation survey completed up to 7 days after enrolment.

Eligibility
Key inclusion criteria
18+ Males and Females, able to communicate in English.
Participants must be attending the Ashes Cricket test as a spectator to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergic 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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We plan to acquire 1000 people to participate. It is expected that 1150 will participate in the study with an approximate 15% attrition rate due to failing to meet eligibility criteria or participate during the expected days. The 15% attrition rate is based on our previous research study. Counts and percentages will be used to analyse the survey data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/11/2017
Actual
23/11/2017
Date of last participant enrolment
Anticipated
27/11/2017
Actual
26/11/2017
Date of last data collection
Anticipated
4/12/2017
Actual
11/12/2017
Sample size
Target
1000
Accrual to date
Final
813
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 18072 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 297960 0
University
Name [1] 297960 0
Queensland University of Technology
Country [1] 297960 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] 297023 0
None
Name [1] 297023 0
Address [1] 297023 0
Country [1] 297023 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299001 0
Queensland University of Technology
Ethics committee address [1] 299001 0
Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Ethics committee country [1] 299001 0
Australia
Date submitted for ethics approval [1] 299001 0
Approval date [1] 299001 0
03/11/2017
Ethics approval number [1] 299001 0
1700000992

Summary
Brief summary
The goal of this study is to investigate whether commercially available UV indicating stickers are acceptable to users and encourages sun protection.
Commercially available cosmetic products have been developed and marketed direct to consumers, which use a UV light activated (photochromic) ink to illustrate that sunscreen is no longer protecting their skin adequately. To assess this product and if it adds any benefit for future public health programs we are conducting a study at the Ashes Cricket Test at the Brisbane Cricket Ground, commonly known as the Gabba, which is a major sports stadium in Brisbane. The event is being held November 23rd – November 27th 2017. The researchers will be at the venue entry and will ask interested members of the public to consent to participate before they enter the stadium. Participants in the intervention group will be asked to complete a brief baseline survey and be provided with 1 sticker and sunscreen. After using the sticker at the cricket, participants will be emailed an evaluation survey to complete. Participants will have 7 days after using the sticker to complete the evaluation survey. A comparative control group will be provided with sunscreen only (no stickers).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78958 0
Dr Elke Hacker
Address 78958 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 78958 0
Australia
Phone 78958 0
+61 7 3138 9674
Fax 78958 0
Email 78958 0
[email protected]
Contact person for public queries
Name 78959 0
Dr Elke Hacker
Address 78959 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 78959 0
Australia
Phone 78959 0
+61 7 3138 9674
Fax 78959 0
Email 78959 0
[email protected]
Contact person for scientific queries
Name 78960 0
Dr Elke Hacker
Address 78960 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 78960 0
Australia
Phone 78960 0
+61 7 3138 9674
Fax 78960 0
Email 78960 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseUV detection stickers can assist people to reapply sunscreen.2019https://dx.doi.org/10.1016/j.ypmed.2019.05.005
N.B. These documents automatically identified may not have been verified by the study sponsor.