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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06878001




Registration number
NCT06878001
Ethics application status
Date submitted
4/03/2025
Date registered
25/03/2025

Titles & IDs
Public title
CaroRite™ for Skin Health and Signs of Ageing
Scientific title
CaroRite™ for Improving Skin Health and the Visible Signs of Ageing, a Placebo Controlled, Double Blind, Randomised Clinical Trial
Secondary ID [1] 0 0
BIOCAR
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Skin Condition 0 0
Ageing Signs 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Carotenoids
Other interventions - Placebo

Experimental: CaroRite - CaroRite capsule containing carotenoids with sunflower oil. 1 capsule to be taken each day for 12 weeks.

Placebo comparator: Placebo - Placebo capsule containing sunflower oil. 1 capsule to be taken each day for 12 weeks.


Treatment: Other: Carotenoids
CaroRite capsule containing carotenoids with sunflower oil. 1 capsule to be taken each day for 12 weeks.

Other interventions: Placebo
Placebo capsule containing sunflower oil. 1 capsule to be taken each day for 12 weeks.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to the end of the study period in Visible signs of ageing
Timepoint [1] 0 0
Baseline to week 12
Secondary outcome [1] 0 0
Change from baseline to the end of the study period in Transepidermal water loss (TEWL)
Timepoint [1] 0 0
Baseline to week 12
Secondary outcome [2] 0 0
Change from baseline to the end of the study period in Skin collagen thickness
Timepoint [2] 0 0
Baseline to week 12
Secondary outcome [3] 0 0
Change from baseline to the end of the study period in Skin carotenoid analysis
Timepoint [3] 0 0
Baseline to week 12
Secondary outcome [4] 0 0
Change from baseline to the end of the study period in Safety and adverse events
Timepoint [4] 0 0
Baseline to week 12
Secondary outcome [5] 0 0
Change from baseline to the end of the study period in Participant self-assessment of product effectiveness
Timepoint [5] 0 0
Baseline to week 12
Secondary outcome [6] 0 0
Change from baseline to the end of the study period in Self-administered carotenoid intake questionnaire
Timepoint [6] 0 0
Baseline to week 12
Secondary outcome [7] 0 0
Change from baseline to the end of the study period in 24-hour diet recall
Timepoint [7] 0 0
Baseline to week 12

Eligibility
Key inclusion criteria
* Females 40-55 years (inclusive)
* Generally healthy
* BMI 18.5-29.9 kg/m2 (inclusive)
* Able to provide informed consent
* Agree not to change regular skincare routine
* Agree to not participate in another clinical trial while enrolled in this trial
* Agree to not significantly change current diet and/or exercise frequency or intensity during study period
Minimum age
40 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Regularly taking carotenoid containing medication/supplements within the previous 2 months
* Have a serious illness e.g. mood disorders such as clinical depression, anxiety disorder or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
* Have an unstable illness e.g. diabetes and thyroid gland dysfunction
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Within the last 12-months received cosmetic surgery or procedures, including Botox and other injectables, microdermabrasion and laser treatments on their face
* Within the last 12-months taken 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.
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (>14 alcoholic drinks week)
* Pregnant or lactating women
* Allergic to any of the ingredients in active or placebo formula
* Participants who are currently participating in any other clinical trial or who have participated in a clinical trial that may affect skin health during the past 1 month
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion

Study design
Purpose of the study
Treatment
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
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RDC Clinical Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Bio-Gen Extracts Pvt. Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Salman Mehkri
Address 0 0
Bio-gen Extracts
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06878001