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Completed

NCT Number: NCT06878001

CaroRite™ for Skin Health and Signs of Ageing

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.

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Key information

Conditions

Healthy Volunteer Ageing Signs Skin Condition Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

RDC Clinical

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carotenoids

Dietary Supplement

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

Other names: CaroRite

Placebo

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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.

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Collaborators

  • Bio-Gen Extracts Pvt. Ltd.

Registry information

Official study title

CaroRite™ for Improving Skin Health and the Visible Signs of Ageing, a Placebo Controlled, Double Blind, Randomised Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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