NCT06571409
Completed
Not Applicable
Clinical Evaluation of the Efficacy of a Dietary Supplement Claiming Anti-aging Properties and UV-protection in Healthy Adults: a Randomized, Double-blind, Placebo Controlled, Parallel, Clinical Trial
ConditionsHealthy Volunteers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Volunteers
- Sponsor
- Seppic
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Skin profilometry
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The study aims to assess the anti-aging and photoprotective efficacy of two active concentrations of a food supplement composed of Coriander Seed Oil (CSO).
Detailed Description
A double blind, parallel groups, placebo-controlled study is carried out on 90 female subjects aged between 35 and 65 years old with visible Crow's feet wrinkles and mild to moderate skin slackness. The study foresees 56 days of products intake. Evaluations of the parameters under study are performed at baseline, after 14, 28 and 56 days of products consumption.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy female subjects
- •Caucasian ethnicity
- •Age between 35 and 65 years old (extremes included)
- •Phototype I to III (with all skin types without any specific repartition)
- •Visible Crow's feet wrinkles (\> 2 according to Skin Aging Atlas - Caucasian Type - Bazin Roland) and mild to moderate skin slackness at cheek level (grade 1-3 - internal clinical scale)
- •Subjects who have not been recently involved in any other similar study (at least 1 month of wash-out)
- •Subjects registered with health social security or health social insurance
- •Subjects having signed the Informed Consent Form (ICF) and Privacy Policy for their participation in the study and a photograph authorization
- •Subjects able to understand the language used in the investigation center and the information given
- •Subjects able to comply with the protocol and follow protocol constraints and specific requirements
Exclusion Criteria
- •Subject is taking part or planning to participate to another clinical study in the same or in another investigation center
- •Subject who is deprived of freedom by administrative or legal decision or under guardianship
- •Subject admitted in a sanitary or social facilities
- •Subject who is planning an hospitalization during the study
- •Subjects under treatment with food supplements which could interfere with the functionality of the product under study
- •Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (if women of childbearing potential)
- •Subject has started or changed estrogen-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study
- •Subject having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •Subjects under radiotherapy, chemotherapy at any time
- •Subject having a skin condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
Outcomes
Primary Outcomes
Skin profilometry
Time Frame: 56 days
Primos 3D
Secondary Outcomes
- Skin elasticity(56 days)
- Self-assessment of product efficacy(56 days)
- Erythema index(56 days)
- Transepidermal water loss(56 days)
- Skin inflammation (subgroup of 20 subjects)(56 days)
- Skin lipoxidation (subgroup of 20 subjects)(56 days)
Study Sites (1)
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