Clinical trial NCT06571409: Clinical Evaluation of the Efficacy of a Dietary Supplement Claiming Anti-aging Properties and UV-protection
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Seppic
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 99
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Willingness to use during all the study period only the product to be tested
* Willingness not to use similar products that could interfere with the expected product effect to be tested (e.g. with antiaging or soothing or UV protection efficacy)
* Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet etc.)
* Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial
* Subjects who have not sun exposure (both natural or artificial) for at least two months
* Subjects who accept not to expose in intensive way to UV rays during the whole study duration
* Subjects who have not been involved in any sun test (for SPF evaluation) or tests that provide skin irradiation since less than two months

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
* Pharmacological treatments (topic or systemic) known to interfere with skin metabolism/physiology
* Subjects under locally pharmacological/non-pharmacological treatment applied on the skin area monitored during the test
* Subject with known or suspected sensitization to one or more test formulation ingredients
* Subjects considered as not adequate to participate to the study by the investigator
* Adult protected by law (under control or hospitalized in public or private institutions for reasons other than research, or incarcerated)
* Subjects not able to communicate or cooperate with the investigator for problems related to language, mental retardation or impaired brain function

Primary outcomes:
measure: Skin profilometry
timeFrame: Baseline
measure: Skin profilometry
timeFrame: 14 days
measure: Skin profilometry
timeFrame: 28 days
measure: Skin profilometry
timeFrame: 56 days
Secondary outcomes:
measure: Skin elasticity
timeFrame: Baseline
measure: Skin elasticity
timeFrame: 14 days
measure: Skin elasticity
timeFrame: 28 days
measure: Skin elasticity
timeFrame: 56 days
measure: Transepidermal water loss
timeFrame: Baseline
measure: Transepidermal water loss
timeFrame: 14 days
measure: Transepidermal water loss
timeFrame: 28 days
measure: Transepidermal water loss
timeFrame: 56 days
measure: Erythema index
timeFrame: Baseline
measure: Erythema index
timeFrame: 28 days
measure: Erythema index
timeFrame: 56 days
measure: Skin inflammation (subgroup of 20 subjects)
timeFrame: Baseline
measure: Skin inflammation (subgroup of 20 subjects)
timeFrame: 56 days
measure: Skin lipoxidation (subgroup of 20 subjects)
timeFrame: Baseline
measure: Skin lipoxidation (subgroup of 20 subjects)
timeFrame: 56 days
measure: Self-assessment of product efficacy
timeFrame: 56 days
Other outcomes:
Locations:
city: San Martino Siccomario
country: Italy
facility: Complife Italia S.r.l
Study officials:
affiliation: Complife Italia S.r.l
name: Eleonora Spartà
role: STUDY_DIRECTOR
References: