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Trial registered on ANZCTR


Registration number
ACTRN12621000527864p
Ethics application status
Not yet submitted
Date submitted
19/07/2020
Date registered
5/05/2021
Date last updated
5/05/2021
Date data sharing statement initially provided
5/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Bioactives-Enhanced Sunscreen Trial (BEST): Evaluating the effect of a Mineral Sunscreen containing Bioactive agents against Standard Moisturiser and Sunscreen use on Sun Damage and Pre-cancerous lesions
Scientific title
Randomized, Within-Patient, Clinical Trial Comparing the effect of a Mineral Sunscreen containing Bioactive agents against Standard Moisturiser and Sunscreen use on Sun-damage and Pre-cancerous lesions among persons at higher risk of skin cancer
Secondary ID [1] 301754 0
None
Universal Trial Number (UTN)
U1111-1255-2131
Trial acronym
BEST (Bioactives-Enhanced Sunscreen Trial)
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
actinic keratosis 318211 0
sundamage from UV and other radiation 318212 0
Condition category
Condition code
Skin 316218 316218 0 0
Dermatological conditions
Public Health 316219 316219 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 moisturiser and (participant's previous) sunscreen use episodically as participant has been doing over the years. 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: once daily for the duration of the trial. Expected 3-9 months (including follow up period).
- strategies used to monitor adherence to the intervention: sunscreen diary to be reviewed during follow up visits
- depending on the review visit assessment, the sunscreen use may be continued longer and data collected.
Intervention code [1] 318049 0
Prevention
Intervention code [2] 318050 0
Treatment: Other
Comparator / control treatment
Control treatment is standard dermatologically approved moisturiser (cetomacrogol aqueous with glycerol) along with participant's own sunscreen
Control group
Active

Outcomes
Primary outcome [1] 324409 0
Change in number actinic keratoses - monitored by clinical counts (by physician)
Timepoint [1] 324409 0
3 months post-intervention commencement
Secondary outcome [1] 393678 0
Change in sun damage of skin- monitored by examination with lamps such as Wood's lamp or other similar scans
Timepoint [1] 393678 0
3 months

Eligibility
Key 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
Minimum age
30 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

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)
Sealed containers, with no ingredients listed; marked left limb or right limb to indicate where to use.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As this is an intra-patient trial with each participant serving as treatment arm and placebo, this will be simple randomisation by coin-toss
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22734 0
New Zealand
State/province [1] 22734 0
Auckland

Funding & Sponsors
Funding source category [1] 306185 0
Hospital
Name [1] 306185 0
Skin Surgery Clinic
Address [1] 306185 0
271A Blockhouse Bay Road,
Auckland 0600
New Zealand
Country [1] 306185 0
New Zealand
Primary sponsor type
Individual
Name
Sharad Paul
Address
Sharad Paul, Director
Skin Surgery Clinic
271A Blockhouse Bay Road
Auckland 0600
Country
New Zealand
Secondary sponsor category [1] 306658 0
University
Name [1] 306658 0
Auckland University of Technology
Address [1] 306658 0
Auckland University of Technology (AUT)
Private Bag 92006
Auckland 1142 , New Zealand
Country [1] 306658 0
New Zealand
Other collaborator category [1] 281386 0
Individual
Name [1] 281386 0
Allanah Knight
Address [1] 281386 0
Massey University
Palmerston North 4442
New Zealand
Country [1] 281386 0
New Zealand
Other collaborator category [2] 281387 0
Individual
Name [2] 281387 0
Robin Hankin
Address [2] 281387 0
Dept of mathematical sciences and statistics
Auckland University of Technology
Private Bag 92006
Auckland 1142 , New Zealand
Country [2] 281387 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 306397 0
HDECS (Health and Disability Ethics Committees)
Ethics committee address [1] 306397 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 306397 0
New Zealand
Date submitted for ethics approval [1] 306397 0
17/05/2021
Approval date [1] 306397 0
Ethics approval number [1] 306397 0

Summary
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 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 moisturiser and usual sunscreen when outdoors on the other limb). Evaluation will involve photography, lesion counts and assessment of UV damage.
Trial website
Not applicable
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103742 0
A/Prof Sharad Paul
Address 103742 0
Skin Surgery Clinic
271A Blockhouse Bay Road
Auckland 0600
Country 103742 0
New Zealand
Phone 103742 0
+64 98286438
Fax 103742 0
+64 98286432
Email 103742 0
doctor@skinsurgeryclinic.co.nz
Contact person for public queries
Name 103743 0
A/Prof Sharad Paul
Address 103743 0
Skin Surgery Clinic
271A Blockhouse Bay Road
Auckland 0600
Country 103743 0
New Zealand
Phone 103743 0
+64 98286438
Fax 103743 0
Email 103743 0
doctor@skinsurgeryclinic.co.nz
Contact person for scientific queries
Name 103744 0
A/Prof Sharad Paul
Address 103744 0
Skin Surgery Clinic
271A Blockhouse Bay Road
Auckland 0600
Country 103744 0
New Zealand
Phone 103744 0
+64 98286438
Fax 103744 0
+64 98286432
Email 103744 0
doctor@skinsurgeryclinic.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual data after de-identification
When will data be available (start and end dates)?
3 months following publication of results for a maximum of 5 years.
Available to whom?
case by case basis at the discretion of primary sponsor
Available for what types of analyses?
no specific limitations
How or where can data be obtained?
By contacting lead investigator. Contact doctor@skinsurgeryclinic.co.nz
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 8475 0
Study protocol
Citation [1] 8475 0
Link [1] 8475 0
Email [1] 8475 0
doctor@skinsurgeryclinic.co.nz
Other [1] 8475 0
Type [2] 8543 0
Informed consent form
Citation [2] 8543 0
Link [2] 8543 0
Email [2] 8543 0
Other [2] 8543 0
Summary results
No Results