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Trial registered on ANZCTR


Registration number
ACTRN12617000939392
Ethics application status
Approved
Date submitted
20/06/2017
Date registered
28/06/2017
Date last updated
20/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the performance of UV stickers for effective sunscreen use in Air and Water in healthy adults
Scientific title
A Randomized Clinical Trial to Qualify “SPOT” UV stickers in Air and Water by healthy adults
Secondary ID [1] 292238 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sunburn 303737 0
sun exposure 303738 0
Condition category
Condition code
Skin 303111 303111 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Groups:
There are two arms:
Arm 1: Arm 1 is the dry group, and will apply sunscreen once only at the beginning of the test session and UV SPOT indicating stickers on their lower legs, and be swabbed every 20 minutes for 7 cycles. The research assistant will apply the sunscreen on to the participant over the UV SPOT indicating stickers and lower leg to ensure adequate surface coverage.
Arm 2: Arm 2 will apply sunscreen once only at the beginning of the test session and UV SPOT indicating stickers on their lower legs, with the addition of having at least their lower legs in the pool for 20 minutes each cycle, with a rest break in between (i.e 20 minutes in the pool followed by 10 minutes rest out of the pool, repeated for 7 cycles). The research assistant will apply the sunscreen on to the participant over the UV SPOT indicating stickers and lower leg to ensure adequate surface coverage. Participants will be asked to wait 15 minutes for the sunscreen to soak in before entering the water. Participants can swim in the pool or sit on the edge of the pool with their lower legs submerged in the water.

Participants in both arms will receive 8 spots applied to their legs at the beginning of the test session. The data collection process (7 cycles) for both arms will take up to 4-5 hours to complete.
The sunscreen provided to both arms will be a high quality SPF 50+ water resistant 80min+ sunscreen that conforms to the Australian Standard. Participants will be required to use the sunscreen provided by the research team. Both groups will be indoors for the duration of the study at the Queensland University of Technology. Participants will not be testing the UV SPOT indicating stickers in direct sunlight. The UV SPOT indicating stickers will be removed from the participant by the research assistant, and placed in the sun for assessment between 11am-1pm when the UV index is above 3. All participants will be supervised by the research team during the intervention to ensure intervention adherence. Lifeguards are available at the indoor pool to ensure the swimmers safety at all times.


Intervention code [1] 298399 0
Prevention
Comparator / control treatment
The sunscreen concentration on the skin is the reference field. The sunscreen concentration on the UV SPOT indicating stickers, will be compared to the participants sunscreen concentration on their skin.
Control group
Active

Outcomes
Primary outcome [1] 302488 0
Correlate the amount of sunscreen on the participant’s skin to the amount of sunscreen on the UV SPOT indicating stickers .

The participants skin is swabbed using a 70%w/w 1sq" Rubbing Alcohol Swab, manufactured by BD. The technician wipes the swab over a 10cm^2 area five times, turns the swab around, and wipes 5 more times. The swab is analyzed outside of the testing environment using UV-Vis Spectroscopy to quantify the concentration of sunscreen on the skin. This swabbing procedure was based off of a similar procedure used by Bauer et al 2010 in the Journal Photochemistry and Photobiology.


Timepoint [1] 302488 0
24hrs to 2 days post commencement of intervention the UV SPOT indicating stickers will be assessed in direct sunlight.

The amount of sunscreen on skin is measured at 8 time points (7 cycles total): 0, 20, 40, 60, 80, 100, 120, and 140 minutes after the sunscreen has been applied to the participant. At each of these time points, the skin will be swabbed using the Bauer procedure and the one SPOT sticker will be removed from the participant. At a later time point, all of the SPOT stickers will be brought into the sun by Dr. Hacker to have their colour analyzed using the NIX colour sensor and a photo taken of the SPOTs. Then, the SPOTs will be analyzed using UV-Vis Spectroscopy to quantify the amount of sunscreen on them.
Secondary outcome [1] 336249 0
Assess the colour UV SPOT indicating stickers changes when exposed to sunlight

Timepoint [1] 336249 0
24hrs to 2 days post commencement of intervention the UV SPOT indicating stickers will be assessed in direct sunlight. The stickers have NIX Color Sensor data captured and a photo taken in direct sunlight.

Eligibility
Key inclusion criteria
18+ Males and Females, healthy, able to communicate in English, able to participant in light physical activity.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Sunscreen allergies

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation by computer database (Redcap) will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random-number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Our sample size was calculated in-line with the sunscreen standard testing sample size suggestion of 12 participants. We will have 12 participants for each (pool and dry) group giving a total of 24 participants. For a 95% CI (a=0.05) we would need 56 data points. Each participant ideally will return 8 data points, so this study design safely gathers enough data points to allow for meaningful conclusions to be drawn.
The skin swabs used in this study will allow for a quantitative analysis of the sunscreen correlation between the SPOT stickers and real human skin. Qualitative data will be gathered by a NIX color sensor in order to quantify the colour change using CIELAB colour values. A QUT statistician will independently analyse the data.

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

Funding & Sponsors
Funding source category [1] 296784 0
Commercial sector/Industry
Name [1] 296784 0
Suncayr
Address [1] 296784 0
1/55 Shafston Ave, Kangaroo Point, QLD, 4059
Country [1] 296784 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] 295768 0
None
Name [1] 295768 0
Address [1] 295768 0
Country [1] 295768 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298008 0
Queensland University of Technology
Ethics committee address [1] 298008 0
Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Ethics committee country [1] 298008 0
Australia
Date submitted for ethics approval [1] 298008 0
Approval date [1] 298008 0
16/06/2017
Ethics approval number [1] 298008 0
1700000387

Summary
Brief summary
The proposed clinical trial aims to investigate the performance of the SPOT UV Indicating Stickers in pool water and on dry land. SPOT stickers are applied to a user’s skin before they apply their sunscreen, and their intended function is to change colour to warn users when their sunscreen is no longer protecting them.
Participants in the study will be randomly assigned to one of the two activity groups (pool or dry) and will be wearing both sunscreen and SPOT stickers. Periodically, participants will have their SPOT stickers and skin swabbed, and the colour of the SPOT stickers measured. The aim of the study is to see that the amount of the sunscreen protecting the skin and the amount of sunscreen on the SPOT stickers are correlated. The study also will note that if a sufficient amount of sunscreen has worn off of a user’s skin that the SPOTs are changing colour to warn the user of overexposure to UV light. The study will be run over 3 weekend days, for 5 hours per participant session. The intended outcome is that SPOT stickers are seen to change colour should the amount of sunscreen protecting the users skin goes below a concentration of 0.5mg/cm3.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75718 0
Dr Elke Hacker
Address 75718 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 75718 0
Australia
Phone 75718 0
+61 7 3138 9674
Fax 75718 0
Email 75718 0
elke.hacker@qut.edu.au
Contact person for public queries
Name 75719 0
Dr Elke Hacker
Address 75719 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 75719 0
Australia
Phone 75719 0
+61 7 3138 9674
Fax 75719 0
Email 75719 0
elke.hacker@qut.edu.au
Contact person for scientific queries
Name 75720 0
Dr Elke Hacker
Address 75720 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 75720 0
Australia
Phone 75720 0
+61 7 3138 9674
Fax 75720 0
Email 75720 0
elke.hacker@qut.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary