CClinicalTrials.gg
CompletedNCT06878001Updated Mar 6, 2026

CaroRite™ for Skin Health and Signs of Ageing

A Phase 4 interventional study of Carotenoids and Placebo in Healthy Volunteer, Skin Condition and Ageing Signs, sponsored by RDC Clinical Pty Ltd. Completed at 1 site in Australia. Open to female participants aged 40 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by RDC Clinical Pty Ltd · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
40 Years to 55 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Healthy Volunteer
  • Skin Condition
  • Ageing Signs

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Keywords

  • females
  • Skin Health
  • Carotenoids
03

In context

Skin Diseases

538 studies on the registry are indexed under Skin Diseases; 92 are open to participants now.

This study's enrollment of 80 is above the median of 60 across 372 interventional studies indexed under Skin Diseases.

Browse Skin Diseases studies →

Lead sponsor

RDC Clinical Pty Ltd is the lead sponsor of 34 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    CaroRite

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

    Dietary Supplement: Carotenoids

  • Placebo comparator
    Placebo

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

    Other: Placebo

Interventions

  • Dietary supplementCarotenoids

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

    Also known as: CaroRite

  • OtherPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline to week 12

Secondary outcomes

  1. 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.

    Time frame: Baseline to week 12

  2. 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.

    Time frame: Baseline to week 12

  3. 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.

    Time frame: Baseline to week 12

  4. 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.

    Time frame: Baseline to week 12

  5. 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

    Time frame: Baseline to week 12

  6. 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.

    Time frame: Baseline to week 12

  7. 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

    Time frame: Baseline to week 12

  8. 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.

    Time frame: Baseline to week 12

07

Study locations

1 site
  • RDC Clinical
    Brisbane, Queensland 4006, Australia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06878001
Lead sponsor
RDC Clinical Pty Ltd
Collaborators
Bio-Gen Extracts Pvt. Ltd.
Responsible party
Sponsor
First posted
Mar 14, 2025
Start date
Jul 7, 2025
Primary completion
Dec 11, 2025
Completion
Dec 11, 2025
Last update
Mar 6, 2026

Study contacts

Salman Mehkri
study director · Bio-gen Extracts

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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