Healthy VolunteerPhase 4NCT06878001
CaroRite™ for Skin Health and Signs of Ageing
A Phase 4 study testing Carotenoids in people with Healthy Volunteer and Skin Condition, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial summary
The goal of this study is to investigate the efficacy of carotenoids administered orally on skin health, skin condition and visible signs of ageing in healthy females aged 40-55 years old. Researchers will compare the study product against placebo. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Skin Condition, Ageing Signs
- What is being tested?
- Carotenoids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Jul 2025to 11 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
- Received cosmetic surgery or procedures, including Botox and other injectables, microdermabrasion and laser treatments on their face within last 3 months prior to enrolment and agree not to have these treatments during the study period.
- 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 within 1 month prior to screening.
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- Currently taking carotenoid supplements (Beta-Carotene, Lycopene, Lutein, Zeaxanthin, Astazanthin)
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CaroRite™ for Improving Skin Health and the Visible Signs of Ageing, a Placebo Controlled, Double Blind, Randomised Clinical Trial
The goal of this study is to investigate the efficacy of carotenoids administered orally on skin health, skin condition and visible signs of ageing in healthy females aged 40-55 years old.
Researchers will compare the study product against placebo.
- Conditions
- Healthy Volunteer, Skin Condition, Ageing Signs
- Being tested
- Carotenoids, Placebo
- Keywords
- females, Skin Health, Carotenoids
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarotenoidsDietary supplement
Also called CaroRite
CaroRite capsule containing carotenoids with sunflower oil. 1 capsule to be taken each day for 12 weeks.
PlaceboOther
Placebo capsule containing sunflower oil. 1 capsule to be taken each day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CaroRite | Experimental | CaroRite capsule containing carotenoids with sunflower oil. 1 capsule to be taken each day for 12 weeks. Receives: Dietary Supplement: Carotenoids |
| Placebo | Placebo comparator | Placebo capsule containing sunflower oil. 1 capsule to be taken each day for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to the end of the study period in Visible signs of ageing
Assessed using the A-One Smart Pro, this device provides and automatic skin analysis by scanner and multi-sensor. It uses a high-resolution camera to take photographs of the skin in normal, UV and polarized light. Wrinkles will be measured as thin and thick and rated on a scale of 1-10 in each area of the face: forehead, eyes, mouth and nose. An attached probe measures skin temperature and moisture.
Visible signs of ageing measured include:
- Skin elasticity
- Hydration
- Wrinkle depth and type
- Sebum
- pigmentation
- Skin pH and temperature
Measured: Baseline to week 12
Secondary outcomes (8)
Change from baseline to the end of the study period in Transepidermal water loss (TEWL)
Change from baseline to the end of the study period in Transepidermal water loss (TEWL). Analysed using a DermaLab Combo system with a probe for measurement.
Measured: Baseline to week 12
Change from baseline to the end of the study period in Skin collagen thickness
Change from baseline to the end of the study period in Skin collagen thickness. Analysed using the DermaLab Combo system with a probe to measure.
Measured: Baseline to week 12
Change from baseline to the end of the study period in Skin carotenoid analysis
Change from baseline to the end of the study period in Skin carotenoid analysis. This will be measured using a non-invasive device that measures skin carotenoid levels using reflection spectroscopy.
Measured: Baseline to week 12
Change from baseline to the end of the study period in Safety and adverse events
Change from baseline to the end of the study period in Safety and adverse events. At each point of contact the participant will be asked about adverse events they may have experienced.
Measured: Baseline to week 12
Change from baseline to the end of the study period in Participant self-assessment of product effectiveness
Change from baseline to the end of the study period in Participant self-assessment of product effectiveness. This Consists of questions related to overall satisfaction with the product and specific facial and skin properties
Measured: Baseline to week 12
Change from baseline to the end of the study period in Self-administered carotenoid intake questionnaire
Change from baseline to the end of the study period in Self-administered carotenoid intake questionnaire. The questionnaire consists of 17 questions related to overall satisfaction with the product and specific facial and skin properties.
Measured: Baseline to week 12
Change from baseline to the end of the study period in 24-hour diet recall
Change from baseline to the end of the study period in 24-hour diet recall
Measured: Baseline to week 12
Skin carotenoid analysis (Veggie Metre)
Change from baseline to the end of the study period in Skin carotenoid analysis (Veggie Metre). Analysed using the Veggie Meter analyser. The Veggie Meter® is a non-invasive device that measures skin carotenoid levels using reflection spectroscopy. It shines a specific wavelength of light onto the skin (typically from an LED) and analyses the light that is absorbed and reflected. Carotenoids absorb certain wavelengths of light, and the device quantifies this absorption to determine carotenoid concentration in the skin.
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start7 Jul 2025
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bio-Gen Extracts Pvt. Ltd.
- Responsible party
- Sponsor
- Investigators
- Salman Mehkri, Study director, Bio-gen Extracts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878001
- Sponsor's protocol ID
- BIOCAR
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rao A, Pellow J, Briskey D. CaroRite for improving skin health and the visible signs of aging - a randomised, double-blind, placebo-controlled trial. Front Aging. 2026 Sep 21;7:1858090. doi: 10.3389/fragi.2026.1858090. eCollection 2026.
PubMed 42834982
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CaroRite™ for Improving Skin Health and the Visible Signs of Ageing, a Placebo Controlled, Double Blind, Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06878001
- Acronym / sponsor ID
- BIOCAR
- Conditions
- Healthy Volunteer, Skin Condition, Ageing Signs
- Keywords
- females, Skin Health, Carotenoids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Bio-Gen Extracts Pvt. Ltd.
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to investigate the efficacy of carotenoids administered orally on skin health, skin condition and visible signs of ageing in healthy females aged 40-55 years old.
Researchers will compare the study product against placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CaroRite | Experimental | Dietary Supplement: CarotenoidsCaroRite capsule containing carotenoids with sunflower oil. 1 capsule to be taken each day for 12 weeks. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsule containing sunflower oil. 1 capsule to be taken each day for 12 weeks. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
- Received cosmetic surgery or procedures, including Botox and other injectables, microdermabrasion and laser treatments on their face within last 3 months prior to enrolment and agree not to have these treatments during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarotenoidsAlso: CaroRiteCaroRite capsule containing carotenoids with sunflower oil. 1 capsule to be taken each day for 12 weeks. | Dietary supplement | CaroRite |
| PlaceboPlacebo capsule containing sunflower oil. 1 capsule to be taken each day for 12 weeks. | Other | Placebo |
Primary outcome
Change from baseline to the end of the study period in Visible signs of ageing
Time frame: Baseline to week 12
Assessed using the A-One Smart Pro, this device provides and automatic skin analysis by scanner and multi-sensor. It uses a high-resolution camera to take photographs of the skin in normal, UV and polarized light. Wrinkles will be measured as thin and thick and rated on a scale of 1-10 in each area of the face: forehead, eyes, mouth and nose. An attached probe measures skin temperature and moisture. Visible signs of ageing measured include: * Skin elasticity * Hydration * Wrinkle depth and type * Sebum * pigmentation * Skin pH and temperature
8 secondary outcomes
Change from baseline to the end of the study period in Transepidermal water loss (TEWL)
Time frame: Baseline to week 12
Change from baseline to the end of the study period in Skin collagen thickness
Time frame: Baseline to week 12
Change from baseline to the end of the study period in Skin carotenoid analysis
Time frame: Baseline to week 12
Change from baseline to the end of the study period in Safety and adverse events
Time frame: Baseline to week 12
Change from baseline to the end of the study period in Participant self-assessment of product effectiveness
Time frame: Baseline to week 12
Change from baseline to the end of the study period in Self-administered carotenoid intake questionnaire
Time frame: Baseline to week 12
Change from baseline to the end of the study period in 24-hour diet recall
Time frame: Baseline to week 12
Skin carotenoid analysis (Veggie Metre)
Time frame: Baseline to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Derived from this study: PubMed 42834982Rao A, Pellow J, Briskey D. CaroRite for improving skin health and the visible signs of aging - a randomised, double-blind, placebo-controlled trial. Front Aging. 2026 Sep 21;7:1858090. doi: 10.3389/fragi.2026.1858090. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salman Mehkri study director
Bio-gen Extracts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carotenoids in people with Healthy Volunteer and Skin Condition, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to the end of the study period in Visible signs of ageing (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06878001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.