Photoprotective and antiaging effect of a standardized red orange (Citrus sinensis (L.) Osbeck) extract in Asian and Caucasian subjects: a randomized, double blind, controlled study

BIONAP srl0 sites110 target enrollmentMay 10, 2022

Overview

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35684041/ (added 13/06/2023)

Registry

who.int

Start Date

May 10, 2022

End Date

April 21, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Female and male healthy subjects (between 30\-50% male and 50\-70% female)
•2\. 35 \= age \= 65 years old
•3\. 40% Caucasian (skin phototype\* I to III) and 60% Asian (skin phototype\* III to V) ethnicity
•4\. Mild to moderate skin aging sign including dark spots (grade 2\-4; Skin Aging Atlas by Bazin R.)
•5\. Registration with health social security or health social insurance (if required by national regulations)
•6\. Promise to not use during all the study period topic products/food supplements with similar effect to that one of the product to be tested (antioxidant)
•7\. Commitment to sign the informed consent form (ICF)
•8\. Truthfulness of the personal information declared to the Investigator
•9\. Ability to understand the language used in the investigation centre and the information given
•10\. No recent participation in any other similar study

•1\. Breastfeeding, pregnancy (or unwillingness to take necessary precautions to avoid pregnancy during the study and for at least 3 months before the inclusion visit \[for women of childbearing potential]
•2\. Staring or changing oestrogen\-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study
•3\. Allergies or sensitivity to cosmetic products, toiletries, sunscreens, and/or topical drugs
•4\. Dermatological problems in the test area
•5\. Pharmacological treatments (both locally or systemically)
•6\. Positive anamnesis for atopy (allergic hypersensitivity affecting parts of the body not in direct contact with the allergen)
•7\. Use of self\-tanning products for at least one month before study start
•8\. Habit to use tanning beds,
•9\. Medication with photosensitizing potential, drugs, and/or food supplements able to induce skin coloring, corticoids, currently or during the month before the study start
•10\. Participation in another clinical trial within the last two weeks prior to the inclusion visit and taking part or planning to participate to another clinical trial during the study in the same or another investigation center