CaroRite™ for Skin Health and Signs of Ageing

NCT06878001 | Completed Phase 4

• 1 other identifier: BIOCAR
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Condition; Ageing Signs; Healthy Volunteer

Keywords

females; Skin Health; Carotenoids

Outcome Measures

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

  Baseline to week 12

Secondary Outcomes (8)

• Change from baseline to the end of the study period in Transepidermal water loss (TEWL)

  Baseline to week 12

• Change from baseline to the end of the study period in Skin collagen thickness

  Baseline to week 12

• Change from baseline to the end of the study period in Skin carotenoid analysis

  Baseline to week 12

• Change from baseline to the end of the study period in Safety and adverse events

  Baseline to week 12

• Change from baseline to the end of the study period in Participant self-assessment of product effectiveness

  Baseline to week 12

Study Arms (2)

CaroRite

EXPERIMENTAL

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

Dietary Supplement: Carotenoids

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Carotenoids DIETARY_SUPPLEMENT

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

Also known as: CaroRite

CaroRite

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 40 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bio-Gen Extracts Pvt. Ltd.: collaborator
• RDC Clinical Pty Ltd: lead

Study Sites (1)

RDC Clinical

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Skin Diseases

Interventions

Carotenoids

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Salman Mehkri

  Bio-gen Extracts

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 14, 2025
• Study Start: July 7, 2025
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: March 6, 2026

Record last verified: 2025-03

Locations

AU (1)