BIOCAR Screening - RDC Clinical

BIOCAR Screening Form

"*" indicates required fields

We are looking to enrol 80 generally healthy female participants, aged 40 to 55, who are experiencing visible signs of ageing such as fine lines and wrinkles.

The product being tested contains carotenoids as the active ingredient which is a class of natural pigments found in many fruits and vegetables, and they are known for their potential skin health benefits.

This study aims to evaluate the effectiveness of taking carotenoids orally in improving skin health, enhancing skin condition, and reducing visible signs of ageing.

We will go through some screening questions over the phone today, and if you are found to be suitable to participate, you will required to attend our clinic in Fortitude Valley on three occasions: at baseline, after 6 weeks and again after 12 weeks, during which we will take photographs and perform an analysis of your skin. During your first appointment, you will be given your study product to take daily for the 12 week period.

As this is a randomised placebo-controlled study, you may receive either the active or placebo product, and neither you nor your Trial Coordinator will know which product you have until the end of the study.

Upon completion of the requirements for the study, you will receive $200 to reimburse you for your time and travel expenses.

Do you have any questions so far?

Trial Coordinator Initials*

Participant still interested after study summary?*

Yes

Participant Initials if not inteterested in proceeding

Screening Questions

Are you a female aged 40-55?

Yes

Not Eligible

What is your current skincare routine?

Excluded - cosmetic surgery or procedures, including Botox and other injectables, microdermabrasion and laser treatments on their face

Do you agree not to change your current skincare routine for the duration of the study?

Yes

Not Eligible

Are you currently enrolled in any other clinical trials or have have you participated in any other skin related clinical trials in the last month?

Yes

Not Eligible

Do you agree not to enrol in any another clinical trial while enrolled in this one?

Yes

Not Eligible

Do you have any serious or unstable illneses, including mood disorders such as depression, anxiety or bipolar disorders, or neurological disorders such as MS, kidney disease, liver disease or heart conditions?

mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
unstable illness2 e.g. diabetes and thyroid gland dysfunction

1 A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
2 An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.

Yes - subject has an UNCONTROLLED serious illness

No - subject has a CONTROLLED serious illness (if required refer to Dr / PI)

No - subject has NO SERIOUS illnesses

Not Eligible

Have you had cancer or any chemotherapy or radiotherapy treatments in the last 2 years?

Yes

Not Eligible

Are you currently using any medications or supplements?

excluded - Medications for acne or other skin conditions including topical retinoids (Rein-A, Retrieve) oral retinoids such as Isotretinoin (Roaccutane), benzoyl peroxide, AHA's, serum, chemical peels.
- any carotenoid containing medication/supplements within the previous 2 months

Taking medications/supplements for Skin Health

No Medicines

Taking other stable medications, unrelated to skin health

List

Name

Dose

Frequency

Treatment

Prescribed? (Y/N)

Not Eligible

Are you currently taking any supplements or medications containing carotenoid, or have you within the last 2 months?

Yes

Not Eligible

Have you had any cosmetic surgery or procedures, including Botox and other injectables, microdermabrasion or laser treatments on your face?

Yes

Not Eligible

Do you smoke or use nicotine products, or abuse drugs (prescription or illegal substances)?

Yes

Not Eligible

Do you drink more than 14 standard alcoholic drinks a week, or have you in the past?

Yes

Not Eligible

Do you have any allergies to drugs, herbal supplements or foods?

Exclude if allergic to ingredients in the active or placebo product
Lutein, Zeaxanthin-isomers (trans+meso), Lycopene, Alpha Carotene, Beta Carotene, Sunflower Oil

Yes

List any allergies given

Are you currently pregnant or lactating?

Yes

Not Eligible

Screening Outcome

Passed Screening

Failed Screening

Not Interested

Need to check

Waitlisted

Notes:

Have you informed the participant that we have other studies recruiting that they may be eligible for?

Yes

Why not?

Did the participant seem interested in any other studies?

Yes

Unsure

I am pleased to inform you that you are eligible to participate in the trial, I will now issue you with your participant ID. Please make a note of this as you will use this on your questionnaires and all your results will only be identifiable by this code.

Participant ID*

If person fails screening or is not interested, please just type xxxx. Do NOT put the actual participant ID in this field unless they have PASSED screening.

Are you happy to proceed with enrolment? I will start by asking a few baseline questions while we are on the phone.

Yes

What is your current age?

Are you currently following any particular diet, such as vegetarian, keto etc. If yes, please provide details:

Height in Metres

Weight in KGs

Thanks for your time, we can now find a time for you to come in for your initial appointment. If possible, please come in with a clean face (no makeup or sunscreen).