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

NCT06571409 | Completed

• 1 other identifier: IT0003160/24
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Skin profilometry

  Primos 3D

  Baseline

• Skin profilometry

  Primos 3D

  14 days

• Skin profilometry

  Primos 3D

  28 days

• Skin profilometry

  Primos 3D

  56 days

Secondary Outcomes (16)

• Skin elasticity

  Baseline

• Skin elasticity

  14 days

• Skin elasticity

  28 days

• Skin elasticity

  56 days

• Transepidermal water loss

  Baseline

Study Arms (3)

Coriander Seed Oil - Dose 1

EXPERIMENTAL

Dietary supplement - Coriander Seed Oil dose 1

Dietary Supplement: Coriander Seed Oil - Dose 1

Coriander Seed Oil - Dose 2

EXPERIMENTAL

Dietary supplement - Coriander Seed Oil dose 2

Dietary Supplement: Coriander Seed Oil - Dose 2

Placebo

PLACEBO COMPARATOR

Dietary supplement - Placebo

Dietary Supplement: Placebo

Interventions

Coriander Seed Oil - Dose 1 DIETARY_SUPPLEMENT

The study foresees the intake of 1 capsule per day during 56 days

Coriander Seed Oil - Dose 1

Coriander Seed Oil - Dose 2 DIETARY_SUPPLEMENT

The study foresees the intake of 1 capsule per day during 56 days

Coriander Seed Oil - Dose 2

Placebo DIETARY_SUPPLEMENT

The study foresees the intake of 1 capsule per day during 56 days

Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seppic: lead

Study Sites (1)

Complife Italia S.r.l

San Martino Siccomario, 27028, Italy

Location

Study Officials

• Eleonora Spartà

  Complife Italia S.r.l

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: September 25, 2024
• Primary Completion: January 3, 2025
• Study Completion: January 27, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)