CaroRite™ for Skin Health and Signs of Ageing

NCT ID: NCT06878001

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-07

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer Skin Condition Ageing Signs

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CaroRite

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

Group Type EXPERIMENTAL

Carotenoids

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carotenoids

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CaroRite

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bio-Gen Extracts Pvt. Ltd.

UNKNOWN

Sponsor Role collaborator

RDC Clinical Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Salman Mehkri

Role: STUDY_DIRECTOR

Bio-gen Extracts

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

RDC Clinical

Brisbane, Queensland, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BIOCAR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Beauty Image Efficacy Study
NCT04733755 COMPLETED NA
Skin Care Regimen for Improving Photoaging Signs on the Face
NCT06603857 NOT_YET_RECRUITING PHASE2/PHASE3
Effect of Platelet Rich Plasma on Photoaged Skin
NCT01372566 ACTIVE_NOT_RECRUITING PHASE1/PHASE2