Clinical trial NCT06878001: CaroRite™ for Skin Health and Signs of Ageing
Official title: CaroRite™ for Improving Skin Health and the Visible Signs of Ageing, a Placebo Controlled, Double Blind, Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Healthy Volunteer
Skin Condition
Ageing Signs
Keywords: females
Skin Health
Carotenoids
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Bio-Gen Extracts Pvt. Ltd.
First posted: 2025-03-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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
* Within the last 12-months received cosmetic surgery or procedures, including Botox and other injectables, microdermabrasion and laser treatments on their face
* Within the last 12-months taken 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.
* 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

Primary outcomes:
measure: Change from baseline to the end of the study period in Visible signs of ageing
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Change from baseline to the end of the study period in Transepidermal water loss (TEWL)
timeFrame: Baseline to week 12
measure: Change from baseline to the end of the study period in Skin collagen thickness
timeFrame: Baseline to week 12
measure: Change from baseline to the end of the study period in Skin carotenoid analysis
timeFrame: Baseline to week 12
measure: Change from baseline to the end of the study period in Safety and adverse events
timeFrame: Baseline to week 12
measure: Change from baseline to the end of the study period in Participant self-assessment of product effectiveness
timeFrame: Baseline to week 12
measure: Change from baseline to the end of the study period in Self-administered carotenoid intake questionnaire
timeFrame: Baseline to week 12
measure: Change from baseline to the end of the study period in 24-hour diet recall
timeFrame: Baseline to week 12
measure: Skin carotenoid analysis (Veggie Metre)
timeFrame: Baseline to week 12
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical
state: Queensland
Study officials:
affiliation: Bio-gen Extracts
name: Salman Mehkri
role: STUDY_DIRECTOR
References: