Clinical Evaluation of the Efficacy of a Dietary Supplement Claiming Anti-aging Properties and UV-protection

Not Applicable

Not yet recruiting

• Conditions: Healthy Volunteers

• Registration Number: NCT06571409
• Lead Sponsor: Seppic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Female
• Target Recruitment: 99

Inclusion Criteria

Inclusion Criteria:<br><br> - Healthy female subjects<br><br> - Caucasian ethnicity<br><br> - Age between 35 and 65 years old (extremes included)<br><br> - Phototype I to III (with all skin types without any specific repartition)<br><br> - Visible Crow's feet wrinkles (> 2 according to Skin Aging Atlas - Caucasian Type -<br> Bazin Roland) and mild to moderate skin slackness at cheek level (grade 1-3 -<br> internal clinical scale)<br><br> - Subjects who have not been recently involved in any other similar study (at least 1<br> month of wash-out)<br><br> - Subjects registered with health social security or health social insurance<br><br> - Subjects having signed the Informed Consent Form (ICF) and Privacy Policy for their<br> participation in the study and a photograph authorization<br><br> - Subjects able to understand the language used in the investigation center and the<br> information given<br><br> - Subjects able to comply with the protocol and follow protocol constraints and<br> specific requirements<br><br> - Willingness to use during all the study period only the product to be tested<br><br> - Willingness not to use similar products that could interfere with the expected<br> product effect to be tested (e.g. with antiaging or soothing or UV protection<br> efficacy)<br><br> - Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity,<br> diet etc.)<br><br> - Subjects under effective contraception (oral/not oral) if women of childbearing<br> potential; not expected to be changed during the trial<br><br> - Subjects who have not sun exposure (both natural or artificial) for at least two<br> months<br><br> - Subjects who accept not to expose in intensive way to UV rays during the whole study<br> duration<br><br> - Subjects who have not been involved in any sun test (for SPF evaluation) or tests<br> that provide skin irradiation since less than two months<br><br>Exclusion Criteria:<br><br> - Subject is taking part or planning to participate to another clinical study in the<br> same or in another investigation center<br><br> - Subject who is deprived of freedom by administrative or legal decision or under<br> guardianship<br><br> - Subject admitted in a sanitary or social facilities<br><br> - Subject who is planning an hospitalization during the study<br><br> - Subjects under treatment with food supplements which could interfere with the<br> functionality of the product under study<br><br> - Subject breastfeeding, pregnant or not willing to take necessary precautions to<br> avoid pregnancy during the study (if women of childbearing potential)<br><br> - Subject has started or changed estrogen-progesterone contraception or hormonal<br> treatment, within the 3 months prior to the study or foreseeing it for the duration<br> of the study<br><br> - Subject having an acute, chronic or progressive illness liable to interfere with the<br> study data or considered by the Investigator hazardous for the subject or<br> incompatible with the study requirements<br><br> - Subjects under radiotherapy, chemotherapy at any time<br><br> - Subject having a skin condition liable to interfere with the study data or<br> considered by the Investigator hazardous for the subject or incompatible with the<br> study requirements<br><br> - Pharmacological treatments (topic or systemic) known to interfere with skin<br> metabolism/physiology<br><br> - Subjects under locally pharmacological/non-pharmacological treatment applied on the<br> skin area monitored during the test<br><br> - Subject with known or suspected sensitization to one or more test formulation<br> ingredients<br><br> - Subjects considered as not adequate to participate to the study by the investigator<br><br> - Adult protected by law (under control or hospitalized in public or private<br> institutions for reasons other than research, or incarcerated)<br><br> - Subjects not able to communicate or cooperate with the investigator for problems<br> related to language, mental retardation or impaired brain function

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skin profilometry;Skin profilometry;Skin profilometry;Skin profilometry

Secondary Outcome Measures

Name	Time	Method
Skin elasticity;Skin elasticity;Skin elasticity;Skin elasticity;Transepidermal water loss;Transepidermal water loss;Transepidermal water loss;Transepidermal water loss;Erythema index;Erythema index;Erythema index;Skin inflammation (subgroup of 20 subjects);Skin inflammation (subgroup of 20 subjects);Skin lipoxidation (subgroup of 20 subjects);Skin lipoxidation (subgroup of 20 subjects);Self-assessment of product efficacy