Placebo-controlled clinical and instrumental evaluation of the anti-aging efficacy of a dietary supplement on facial skin
Healthy subjects exhibiting moderate clinical signs of skin aging, such as dark spots and wrinkles or fine lines in the crow’s feet area, nasolabial wrinkles and frontal wrinkles.
The investigational products are food supplements provided as capsules containing Nutroxsun®, a standardized blend of Citrus paradisi and Rosmarinus officinalis extracts, administered at two different dosages. The high-dose formulation provides 250 mg of Nutroxsun®, while the low-dose formulation provides 100 mg of Nutroxsun®. The placebo contains the same excipients without the active ingredient. All products are supplied as identical capsules with the same shell components. A restricted randomization list will be generated by an independent technician using the appropriate algorithm (“Wei’s urn”) of the PASS 11 software (PASS, LLC, Kaysville, UT, USA) and stored in a secure location. The Principal Investigator or designated personnel will dispense the products according to the generated randomization list: 60 subjects will receive the high-dose active product, 60 subjects the low-dose active product, and 60 subjects the placebo. The study will be double-blind, meaning that subjects, the Principal Investigator and collaborators are kept masked to product assignment. The products will be supplied in the same packaging with no obvious differences between them. Subjects will take the assigned treatment for 84 days ± 2 days as follows: one capsule per day, 30 minutes before or after breakfast. To standardize the skincare routine during the study, subjects will receive a neutral base facial cream, which will replace their usual day and night facial creams throughout the study period. Participants will be instructed not to apply the cream on the morning of scheduled study assessments. Subjects will also be asked to maintain their usual dietary habits, avoid additional dietary supplements that could interfere with the study outcomes, and minimize unprotected exposure to sunlight or other UV sources during the study period.
1.Healthy female subjects 2.Subjects of Caucasian and Asian (10% of the panel) ethnicity 3.Subjects aged between 35 and 65 years (extremes included, for Asian subjects the upper age limit may be extended by up to 5 years to ensure eligibility based on the inclusion criteria) 4.Subjects who exhibit moderate clinical signs of skin aging, such as dark spots and wrinkles or fine lines in the crow’s feet area, nasolabial wrinkles and frontal wrinkles 5.Subjects registered with national health service 6.Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel 7.Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel 8.Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements 9.Subjects who commit not to change their daily routine or lifestyle during the study 10.Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study 11.Subjects informed about the test procedures who have signed a consent form and privacy agreement
1.Subjects who do not meet the inclusion criteria 2.Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study 3.Subjects participating or planning to participate in other clinical trials 4.Subjects who participated in a similar study without respecting an adequate washout period (at least one month) 5.Subjects that have food intolerances or food allergies to ingredients of the study product 6.Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator 7.Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month) 8.Subjects admitted to a health or social facility 9.Subjects planning a hospitalization during the study 10.Subjects not able to be contacted in case of emergency 11.Subjects deprived of freedom by administrative or legal decision or under guardianship 12.Subjects who have or have had a history of alcohol or drug addiction 13.Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.) 14. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)