Study to Evaluate the Physiological Effects on the Skin of 3 Food Supplements Versus Placebo in 40-60 Years Old Female Subjects

NCT ID: NCT06254209

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2024-04-30

Brief Summary

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The objective is to evaluate the effects on the skin of 3 foods supplements compared to placebo after daily intake for 3 months in female subjects presenting healthy skin.

Skin parameters measured are: the firmness of the skin and other biomechanical skin properties (elasticity, tonicity, density), cellulitis visibility, radiance complexion, skin condition (microrelief, skin barrier function and moisturizing)

Detailed Description

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Study design: Monocentric, randomized, double blind, placebo controlled, 3 groups in parallel.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin included in capsules for daily administration

Verum1

Combination of clove (Syzygium aromaticum) and immortelle (Helichrysum italicum) extracts

Group Type EXPERIMENTAL

Botanicals extracts

Intervention Type DIETARY_SUPPLEMENT

Powder included in capsules for daily administration

Verum2

Olive fruit extract (Olea europaea)

Group Type EXPERIMENTAL

Botanicals extracts

Intervention Type DIETARY_SUPPLEMENT

Powder included in capsules for daily administration

Verum3

Hibiscus flower extract (Hibiscus sabdariffa)

Group Type EXPERIMENTAL

Botanicals extracts

Intervention Type DIETARY_SUPPLEMENT

Powder included in capsules for daily administration

Interventions

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Botanicals extracts

Powder included in capsules for daily administration

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin included in capsules for daily administration

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Phototype II to IV (Fitzpatrick)
* Visual skin radiance score (face) ≤ 7 (0 to 9 points numeric scale)
* Tactile skin firmness score (cheek) ≤ 7 (0 to 9 points numeric scale)
* Visual cellulite score (thigh) ≥ 3 (0 to 9 points numeric scale)

Exclusion Criteria

* Chronic pathology or systemic disorder
* Subjects presenting imperfections on the test sites
* Pregnant or who are planning to become pregnant
* Medication or condition that may interfere with tested outcomes
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nexira

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Intertek

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Damien Guillemet

Role: CONTACT

+33232831818

Damien Guillemet

Role: CONTACT

Facility Contacts

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M. Vayssiere, Medical doctor

Role: primary

Other Identifiers

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COS04

Identifier Type: -

Identifier Source: org_study_id

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