None listed
Conditions
Brief summary
This study has been designed as an interventional study to determine if daily use of a bioactive-enhanced sunscreen helps reduce precancerous lesions such as actinic keratoses. Currently non-melanoma skin cancer is the most prevalent skin cancer. In New Zealand sunscreens are not regulated. This study is to study the efficacy of a sunscreen (especially developed sunscreen for this study that has passed both the TGA (Australia), EU and FDA regulations, and contains additional bioactive ingredients such as seaweed extracts and niacinamide) in reducing pre-cancerous lesions. At present while physicians (in both primary and secondary care) deal with these pre-cancerous lesions, sunscreen use is not diligently monitored by physicians, and most patients only use sunscreen during planned outdoor exposure. Given even on a cloudy day one has significant UV exposure, and there is also incidental exposure to other artificial lighting and radiation, this study sets out to evaluate the daily application of the study sunscreen over a 3 month period even during periods of no sun exposure. The study is designed as a within-patient (randomized to use the study sunscreen on one limb, and standard sunscreen on the control limb). Evaluation will involve photography, lesion counts and assessment of UV damage.
Interventions
Daily use of a mineral sunscreen containing bioactive agents (even when no sun exposure planned); intra-patient on one side the bioactive sunscreen daily (ipsilateral limb, and on the other (contralateral limb) standard sunscreen use. The anatomical side of each limb will be randomised.
- mode of administration: sunscreen application on sites as directed on the container.
- the duration and frequency of administration: twice daily for the duration of the trial and after water immersion. Expected
Daily use of a mineral sunscreen containing bioactive agents (even when no sun exposure planned); intra-patient on one side the bioactive sunscreen daily (ipsilateral limb, and on the other (contralateral limb) standard sunscreen use. The anatomical side of each limb will be randomised. - mode of administration: sunscreen application on sites as directed on the container. - the duration and frequency of administration: twice daily for the duration of the trial and after water immersion. Expected 3-9 months (including follow up period). - strategies used to monitor adherence to the intervention: sunscreen and sun exposure diary to be reviewed during follow up visits - depending on the review visit assessment, the sunscreen use may be continued longer and data collected.
Sponsors
Skin Surgery Clinic
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
People with outdoor exposure lifestyles, and fair skin (Fitzpatrick I and II) with higher risk of skin cancer) that are regular uses of sunscreen
Exclusion criteria
People unable to manage the treatment regimen during the study period or those unable to provide informed consent. Healthy volunteers will be included if they have sun damage i.e. healthy here refers to general health and not skin health.
Outcome results
None listed