ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12621000527864

Ethics application status

Approved

Date submitted

19/07/2020

Date registered

5/05/2021

Date last updated

28/01/2024

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 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 Sunscreen use on Sun-damage and Pre-cancerous lesions among persons at higher risk of skin cancer

Secondary ID [1]

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

sundamage from UV and other radiation

Condition category

Condition code

Skin

Dermatological conditions

Public Health

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 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.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Other

Comparator / control treatment

Control treatment is standard commercially available sunscreen that will be provided (without bioactive agents)

Control group

Active

Outcomes

Primary outcome [1]

Change in number actinic keratoses - monitored by clinical counts (by physician)

Timepoint [1]

3 Months post intervention commencement

Secondary outcome [1]

Change in sun damage of skin- monitored by examination with lamps such as Wood's lamp or other similar scans

Timepoint [1]

3 Months after intervention and 3 months post study.

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

Sex

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)

Containers of Study Sunscreen and Control Sunscreen will be in unmarked tubs i.e. ingredients not marked.

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

1/05/2025

Actual

Date of last participant enrolment

Anticipated

31/08/2025

Actual

Date of last data collection

Anticipated

30/03/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Skin Surgery Clinic

Address [1]

271A Blockhouse Bay Road,
Auckland 0600
New Zealand

Country [1]

New Zealand

Primary sponsor type

Commercial sector/Industry

Name

Skin Surgery Clinic

Address

Sharad Paul, Director
Skin Surgery Clinic
271A Blockhouse Bay Road
Auckland 0600

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

Auckland University of Technology

Address [1]

Auckland University of Technology (AUT)
Private Bag 92006
Auckland 1142 , New Zealand

Country [1]

New Zealand

Other collaborator category [1]

Individual

Name [1]

Allanah Knight

Address [1]

Massey University
Palmerston North 4442
New Zealand

Country [1]

New Zealand

Other collaborator category [2]

Individual

Name [2]

Robin Hankin

Address [2]

Dept of mathematical sciences and statistics
Auckland University of Technology
Private Bag 92006
Auckland 1142 , New Zealand

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HDECS (Health and Disability Ethics Committees)

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

17/05/2021

Approval date [1]

30/09/2021

Ethics approval number [1]

Ethics ref: 21/CEN/178

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 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.

Trial website

Not applicable

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Sharad Paul

Address

Skin Surgery Clinic
271A Blockhouse Bay Road
Auckland 0600

Country

New Zealand

Phone

+64 98286438

Fax

+64 98286432

doctor@skinsurgeryclinic.co.nz

Contact person for public queries

Name

Sharad Paul

Address

Skin Surgery Clinic
271A Blockhouse Bay Road
Auckland 0600

Country

New Zealand

Phone

+64 98286438

Fax

doctor@skinsurgeryclinic.co.nz

Contact person for scientific queries

Name

Sharad Paul

Address

Skin Surgery Clinic
271A Blockhouse Bay Road
Auckland 0600

Country

New Zealand

Phone

+64 98286438

Fax

+64 98286432

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8543	Informed consent form					380171-(Uploaded-05-03-2021-12-51-56)-Study-related document.doc
15048	Ethical approval					380171-(Uploaded-04-02-2022-14-17-44)-Study-related document.pdf

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.

Trial Review

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Documents added manually

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