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

Nexira1 site in 1 country132 target enrollmentNovember 6, 2023

ConditionsHealthy Volunteers

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy Volunteers
Sponsor: Nexira
Enrollment: 132
Locations: 1
Primary Endpoint: Firmness of the skin
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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

Registry

clinicaltrials.gov

Start Date

November 6, 2023

End Date

April 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Nexira

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Outcomes

Primary Outcomes

Firmness of the skin

Time Frame: Day 0 (inclusion) and Day 84 (last visit)

Cutometry measurements using Cutometer (cheekbone)

Secondary Outcomes

Score of fine lines visibility on face, assessed by panelist (trained technician)(Day 0 (inclusion) and Day 84 (last visit))
Score of skin radiance of face, assessed by panelist (trained technician)(Day 0 (inclusion) and Day 84 (last visit))
Score of skin firmness (tactile pinch of right cheek), assessed by panelist (trained technician)(Day 0 (inclusion) and Day 84 (last visit))
Skin elasticity and tonicity(Day 0 (inclusion) and Day 84 (last visit))
Score of nourishing aspect (hydration and quality aspect) of face, assessed by panelist (trained technician)(Day 0 (inclusion) and Day 84 (last visit))
Skin density(Day 0 (inclusion) and Day 84 (last visit))
Score of cellulite visibility (right thigh), assessed by panelist (trained technician)(Day 0 (inclusion) and Day 84 (last visit))
Skin color texture - Haralick parameter (contrast & entropy - no unit)(Day 0 (inclusion) and Day 84 (last visit))
Score of skin softness (tactile perception of right cheek), assessed by panelist (trained technician)(Day 0 (inclusion) and Day 84 (last visit))
Dimpled skin - surface (mm2) of humps and dimples(Day 0 (inclusion) and Day 84 (last visit))
Skin specular reflectance (spectral reflectance - no unit)(Day 0 (inclusion) and Day 84 (last visit))
Dimpled skin - volume (mm3) of humps and dimples(Day 0 (inclusion) and Day 84 (last visit))
Skin luminosity - CIELAB (L*a*b)(Day 0 (inclusion) and Day 84 (last visit))
Skin barrier function (g/h/m²)(Day 0 (inclusion) and Day 84 (last visit))
Self perceived questionnaire (4 scales)(Day 0 (inclusion), Day 42 (intermediate) and Day 84 (last visit))
Skin roughness (mean height - µm)(Day 0 (inclusion) and Day 84 (last visit))
Skin moisture (%)(Day 0 (inclusion) and Day 84 (last visit))