Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
80 participants
INTERVENTIONAL
2025-07-07
2025-12-31
Brief Summary
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Researchers will compare the study product against placebo.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CaroRite
CaroRite capsule containing carotenoids with sunflower oil. 1 capsule to be taken each day for 12 weeks.
Carotenoids
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.
Placebo
Placebo capsule containing sunflower oil. 1 capsule to be taken each day for 12 weeks.
Interventions
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Carotenoids
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
55 Years
FEMALE
Yes
Sponsors
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Bio-Gen Extracts Pvt. Ltd.
UNKNOWN
RDC Clinical Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Salman Mehkri
Role: STUDY_DIRECTOR
Bio-gen Extracts
Locations
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RDC Clinical
Brisbane, Queensland, Australia
Countries
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Other Identifiers
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BIOCAR
Identifier Type: -
Identifier Source: org_study_id
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