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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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
Universal Trial Number (UTN)
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

Study type
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
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 306185 0
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
Sharad Paul
Sharad Paul, Director
Skin Surgery Clinic
271A Blockhouse Bay Road
Auckland 0600
New Zealand
Secondary sponsor category [1] 306658 0
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
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
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
Approval date [1] 306397 0
Ethics approval number [1] 306397 0

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

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
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
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
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
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