None listed
Conditions
Brief summary
Finding the balance between the risks and benefits of sun exposure is extremely challenging. The Cancer Council Australia and other organisations now advise daily sunscreen use to reduce UV radiation-induced damage arising from incidental exposure. Sunscreen blocks vitamin D production in experimental settings but there are no data about the effect of frequent application of high SPF sunscreens in community settings. Despite this, there is a widely held perception that using sunscreen will increase the risk of vitamin D deficiency and this is undermining skin cancer prevention messages. We plan a two-arm open-label RCT with a one-year intervention phase. The primary aim is to determine whether participants randomised to provision of a broad-spectrum SPF 50+ sunscreen, and advice to apply it to all body parts uncovered by clothing on all days when the UVI is forecast to reach 3, have a lower mean 25 hydroxyvitamin D (25(OH)D) concentration at the end of either summer or winter than those randomised to usual discretionary sunscreen use. If daily sunscreen use reduces 25(OH)D concentration, we will model the impact on the prevalence of vitamin D deficiency in Australia to assess the public health significance of the change
Interventions
We plan a two-arm open-label RCT with a one-year intervention phase to assess the effect of high SPF sunscreen application on vitamin D. Participants will be recruited from the four eastern states of Australia (QLD, NSW, VIC & TAS) and the intervention will be self-administered. Participants will be randomly assigned to sunscreen and control groups. At baseline, both groups will be provided with advice about sun protection during planned outdoor activities will be provided at enrolment. This adv
We plan a two-arm open-label RCT with a one-year intervention phase to assess the effect of high SPF sunscreen application on vitamin D. Participants will be recruited from the four eastern states of Australia (QLD, NSW, VIC & TAS) and the intervention will be self-administered. Participants will be randomly assigned to sunscreen and control groups. At baseline, both groups will be provided with advice about sun protection during planned outdoor activities will be provided at enrolment. This advice will be based on existing public health recommendations from Cancer Council Australia. The advice will be developed by the principle investigator and project manager in collaboration with the extended investigator team. It will be provided to all participants via email, along with the notification about their study group assignment. The intervention group will be provided with a 1-year supply of a broad-spectrum SPF 50+ sunscreen, and asked to apply it to all body parts uncovered by clothing on all days when the ultraviolet index (UVI) is forecast to reach 3. They will be asked to view an animated video clip that describes when and how to apply the sunscreen. Study sunscreen has been chosen from the range of products commercially available in Australia. Two sunscreen products will be purchased from Key Pharmaceuticals: Hamilton Active Family SPF 50+, and Hamilton Everyday Face 50+. All participants in the intervention group will be supplied with Hamilton Active Family SPF 50+ (500 mL). A separate facial sunscreen will be offered and supplied if preferred; Hamilton Everyday Face SPF 50+ (75gm). Weekly text and/or email reminders, regular phone contact, and access to a closed Facebook group will support participants in the active group to comply with the intervention. Weekly messages will alert participants to the UVI in their area, and they will also be asked to download and familiarize themselves with the free Sunsmart app. Phone contact will be made by study staff after the first two weeks, and then bi-monthly to identify barriers to sunscreen application and suggest solutions. Participation in a closed Facebook group will provide access to videos and hints about sunscreen application, sunscreen and sun exposure facts and an additional opportunity for participants to ask questions. All participants will be asked to complete short online monthly surveys about their sunscreen use, clothing, and time outdoors. Those in the sunscreen group will be asked about use of study sunscreen and any additional sunscreen used. Compliance will be calculated as the number of days applied (using self-reported frequency from the monthly surveys) divided by the number expected (estimated number of days where the forecast maximum UVI at the closest town was =3). Participants will also be asked to return bottles to be weighed.
Sponsors
QIMR Berghofer Medical Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria: • Provide electronic consent to participate • Willing to comply with all study procedures and be available for the duration of the study • Aged 30 to 65 • Resident of Queensland, New South Wales, Victoria or Tasmania • Fitzpatrick skin type 1 to 4
Exclusion criteria
People will be excluded if they are unable to provide consent or unable to communicate well enough in English to understand study requirements. In addition, they will be excluded if they: • Have a history of allergic skin reaction • Have an autoimmune condition that affects the skin, such as psoriasis, lupus of the skin, scleroderma • Have a history of melanoma within the past 5 years • Are currently using sunscreen on a regular basis (i.e., > 2 days per week), excluding makeup or moisturiser with max SPF 15+ on the face • Are taking or plan to start taking > 400 IU/day of supplementary vitamin D • Do not have a phone • Do not have access to electronic device suitable for survey completion and receiving reminders.
Outcome results
None listed