None listed
Conditions
Brief summary
Sun damaged skin can attract harmful bacteria that may secrete toxins that promote further damage and progression to skin cancer. This study aims to assess whether application of different skin creams including a probiotic and sunscreen has any effect on the type of bacteria that grow on sun damaged skin. Who is it for? You may be eligible for this study if you are aged 40 or older and you have known areas of sun damaged skin, which may or may not have lesions called 'actinic keratosis'. Please note that this study will *not* be enrolling patients with a diagnosis of skin cancer, melanoma or otherwise. Study details All participants who choose to enroll in this study will be randomly allocated by chance (similar to flipping a coin) to one of four different skin creams. You will be asked to apply your allocated skin cream directly to sun damaged skin on one side of your body, and nothing to the other side of your body for comparison. Application of the creams will occur 2x daily for 14 days. After 2 weeks of applying the creams, we will take samples (swabs) of your skin bacteria and determine the types of bacteria that have been growing. We will also take additional swabs at 3 weeks, 3 months and 6 months to determine any long terms changes in your skin bacteria. It is hoped this research will determine whether it is possible to change the bacteria that grow on your sun damaged skin to other (less harmful) bacteria that are found on normal skin. In the long term, this research might lead to a treatment for sun damaged skin, which may reduce the risk of skin cancer.
Interventions
The intervention will be a topical ointment containing live bacteria, Cutibacterium acnes. C. acnes possess a number of unique properties that may render it a good candidate for a topical probiotic. For this project most relevant is property is its high level of antioxidant activity due to the production of the Radical oxygenase of Propionibacterium acnes (RoxP) protein. Of particular interest is the interface between RoxP, UV radiation and squamous cell carcinoma.
Upon consent, patients will
The intervention will be a topical ointment containing live bacteria, Cutibacterium acnes. C. acnes possess a number of unique properties that may render it a good candidate for a topical probiotic. For this project most relevant is property is its high level of antioxidant activity due to the production of the Radical oxygenase of Propionibacterium acnes (RoxP) protein. Of particular interest is the interface between RoxP, UV radiation and squamous cell carcinoma. Upon consent, patients will be provided with one of four creams. This includes: 1. Cancer Council SPF50+ sunscreen ointment 2. Mupirocin (2%w/w) topical antibiotic 3. C. acnes ointment (anhydrous gel that includes 1×10^8 CFU/mL C. acnes) 4. Ointment with no C. acnes (anhydrous gel) All ointments will be applied twice daily for 14 days at a dose of 0.5mL (consistent for each ointment) and participants will self administer the ointment. On the initial visit, the research nurse will explain and demonstrate how to apply the ointment, and provide a paper copy of instructions on the 2x daily application. Participants will be issued a diary to ensure they complete the all applications, and mark anywhere that may have been missed. The container will also be weighed at the beginning and end of trial by researchers to ensure compliance with the amount of product applied.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
o Consenting o Solar damage +/- AK o Aged >40
Exclusion criteria
o Cancers or other major skin disorders o Other major health problems requiring acute intervention o Antibiotic use now or within 4 weeks o Allergies to topical ointments o Eczema o Routine skin treatment
Outcome results
None listed