Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000993897
Ethics application status
Approved
Date submitted
16/06/2021
Date registered
28/07/2021
Date last updated
4/08/2023
Date data sharing statement initially provided
28/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the ability of topical probiotics to change the bacterial profile of actinic keratosis from a detrimental to healthy composition
Scientific title
Investigating the ability of topical probiotics to alter the bacterial microbiome of actinic keratosis in adults over 40
Secondary ID [1] 302974 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MiMoSa
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Actinic Keratosis 320203 0
Bacterial population on actinic keratosis 320204 0
Condition category
Condition code
Skin 318145 318145 0 0
Dermatological conditions
Infection 320326 320326 0 0
Studies of infection and infectious agents
Cancer 320327 320327 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 319410 0
Treatment: Other
Intervention code [2] 319411 0
Prevention
Comparator / control treatment
The patient will be used as their own control as this is a split body design study. One of the patients arms will be used for a treatment, and the other arm (non-intervention limb) will not have any ointment.
Control group
Active

Outcomes
Primary outcome [1] 327419 0
Any change in the actinic keratosis micobiome assessed by lesion swab and 16S amplicon sequencing
Timepoint [1] 327419 0
Day 14 (the first day post-intervention completion).
Secondary outcome [1] 395068 0
Any change in the S. aureus population inhabiting the actinic keratosis lesions assessed by lesion swab and 16S amplicon sequencing
Timepoint [1] 395068 0
Day 14 (the first day post-intervention completion).
Secondary outcome [2] 395069 0
Long term change in actinic keratosis microbiome assessed by lesion swab and 16S amplicon sequencing
Timepoint [2] 395069 0
Day 21 , 90 and 180 post intervention commencement

Eligibility
Key inclusion criteria
o Consenting
o Solar damage +/- AK
o Aged >40
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/08/2021
Actual
1/12/2021
Date of last participant enrolment
Anticipated
31/07/2023
Actual
5/04/2023
Date of last data collection
Anticipated
9/02/2024
Actual
12/07/2023
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19292 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 33873 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 307392 0
Government body
Name [1] 307392 0
NHMRC
Country [1] 307392 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia, Queensland 4068
Country
Australia
Secondary sponsor category [1] 309378 0
None
Name [1] 309378 0
Address [1] 309378 0
Country [1] 309378 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307479 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 307479 0
Princess Alexandra Hospital ,
199 Ipswich Rd, Woolloongabba QLD 4102
Ethics committee country [1] 307479 0
Australia
Date submitted for ethics approval [1] 307479 0
01/04/2021
Approval date [1] 307479 0
19/07/2021
Ethics approval number [1] 307479 0
HREC/2021/QMS/68254

Summary
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.
Trial website
Trial related presentations / publications
Public notes
In first in vitro studies investigating C. acnes, it was shown that RoxP can protect skin cells from DNA damage induced by UV radiation. A study conducted by Andersson and colleagues (2019) studied protein abundance on AKs and found that the concentration of RoxP and C. acnes was significantly lower in the diseased region compared to healthy skin.

Contacts
Principal investigator
Name 107374 0
Prof Ian Frazer
Address 107374 0
The University of Queensland Diamantina Institute.
Translational Research Institute:
37 Kent Street, Woolloongabba, Queensland 4102
Country 107374 0
Australia
Phone 107374 0
+61 7 344 38042
Fax 107374 0
Email 107374 0
[email protected]
Contact person for public queries
Name 107375 0
Ian Frazer
Address 107375 0
The University of Queensland Diamantina Institute
Translational Research Institute:
37 Kent Street, Woolloongabba, Queensland 4102
Country 107375 0
Australia
Phone 107375 0
+61 7 344 38042
Fax 107375 0
Email 107375 0
[email protected]
Contact person for scientific queries
Name 107376 0
Jacoba Bromfield
Address 107376 0
The University of Queensland Diamantina Institute
Translational Research Institute:
37 Kent Street, Woolloongabba, Queensland 4102
Country 107376 0
Australia
Phone 107376 0
+61 498581196
Fax 107376 0
Email 107376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11596Informed consent form    381079-(Uploaded-06-05-2021-13-17-16)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.