None listed
Conditions
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.
Interventions
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 indica
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.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
18+ Males and Females, healthy, able to communicate in English, able to participant in light physical activity.
Exclusion criteria
Sunscreen allergies
Outcome results
None listed