CaroRite™ for Skin Health and Signs of Ageing

March 4, 2026 updated by: RDC Clinical Pty Ltd

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4006
        • RDC Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

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

  • 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.
    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CaroRite
CaroRite capsule containing carotenoids with sunflower oil. 1 capsule to be taken each day for 12 weeks.
Dietary supplement: Carotenoids
CaroRite capsule containing carotenoids with sunflower oil. 1 capsule to be taken each day for 12 weeks.
Other Names:
  • CaroRite
Placebo Comparator: Placebo
Placebo capsule containing sunflower oil. 1 capsule to be taken each day for 12 weeks.
Other: Placebo
Placebo capsule containing sunflower oil. 1 capsule to be taken each day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Transepidermal water loss (TEWL). Analysed using a DermaLab Combo system with a probe for measurement.
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 collagen thickness. Analysed using the DermaLab Combo system with a probe to measure.
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 Skin carotenoid analysis. This will be measured using a non-invasive device that measures skin carotenoid levels using reflection spectroscopy.
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 Safety and adverse events. At each point of contact the participant will be asked about adverse events they may have experienced.
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 Participant self-assessment of product effectiveness. This Consists of questions related to overall satisfaction with the product and specific facial and skin properties
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 Self-administered carotenoid intake questionnaire. The questionnaire consists of 17 questions related to overall satisfaction with the product and specific facial and skin properties.
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
Change from baseline to the end of the study period in 24-hour diet recall
Baseline to week 12
Skin carotenoid analysis (Veggie Metre)
Time Frame: Baseline to week 12
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.
Baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RDC Clinical Pty Ltd

Collaborators

Bio-Gen Extracts Pvt. Ltd.

Investigators

  • Study Director: Salman Mehkri, Bio-gen Extracts

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2025

Primary Completion (Actual)

December 11, 2025

Study Completion (Actual)

December 11, 2025

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOCAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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