CaroRite™ for Skin Health and Signs of Ageing

RDC Clinical

Status and phase: Active, not recruiting; Phase 4

Conditions: Skin Condition; Ageing Signs; Healthy Volunteer

Treatments: Dietary Supplement: Carotenoids; Other: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06878001

BIOCAR

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

CaroRite

Experimental group

Description:

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

Treatment:

Dietary Supplement: Carotenoids

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo