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

Not Applicable

Recruiting

• Conditions: Healthy Volunteers

• Registration Number: NCT06254209
• Lead Sponsor: Nexira

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.

Study Timeline

• Study Start: 2023-11-06
• Study First Submitted: 2023-12-18
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-12
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Firmness of the skin	Day 0 (inclusion) and Day 84 (last visit)	Cutometry measurements using Cutometer (cheekbone)

Secondary Outcome Measures

Name	Time	Method
Score of fine lines visibility on face, assessed by panelist (trained technician)	Day 0 (inclusion) and Day 84 (last visit)	10 points numeric scale: 0 (not visible) to 9 (highly visible)
Score of skin radiance of face, assessed by panelist (trained technician)	Day 0 (inclusion) and Day 84 (last visit)	10 points numeric scale: 0 (dull) to 9 (radiant)
Score of skin firmness (tactile pinch of right cheek), assessed by panelist (trained technician)	Day 0 (inclusion) and Day 84 (last visit)	10 points numeric scale: 0 (sagging) to 9 (firm)
Skin elasticity and tonicity	Day 0 (inclusion) and Day 84 (last visit)	Cutometry measurements using the Cutometer (cheekbone)
Score of nourishing aspect (hydration and quality aspect) of face, assessed by panelist (trained technician)	Day 0 (inclusion) and Day 84 (last visit)	10 points numeric scale: 0 (malnourished) to 9 (nourished)
Skin density	Day 0 (inclusion) and Day 84 (last visit)	Ultrasound imaging device (lower cheek)
Score of cellulite visibility (right thigh), assessed by panelist (trained technician)	Day 0 (inclusion) and Day 84 (last visit)	10 points numeric scale: 0 (not visible) to 9 (highly visible)
Skin color texture - Haralick parameter (contrast & entropy - no unit)	Day 0 (inclusion) and Day 84 (last visit)	Standardized pictures acquisitions (face) and software integration
Score of skin softness (tactile perception of right cheek), assessed by panelist (trained technician)	Day 0 (inclusion) and Day 84 (last visit)	10 points numeric scale: 0 (rough) to 9 (soft)
Dimpled skin - surface (mm2) of humps and dimples	Day 0 (inclusion) and Day 84 (last visit)	Picture acquisition by fringe projection (on tight) and software integration
Skin specular reflectance (spectral reflectance - no unit)	Day 0 (inclusion) and Day 84 (last visit)	Standardized pictures acquisitions (face) and software integration
Dimpled skin - volume (mm3) of humps and dimples	Day 0 (inclusion) and Day 84 (last visit)	Picture acquisition by fringe projection (on tight) and software integration
Skin luminosity - CIELAB (L*a*b)	Day 0 (inclusion) and Day 84 (last visit)	Standardized pictures acquisitions (face) and software integration
Skin barrier function (g/h/m²)	Day 0 (inclusion) and Day 84 (last visit)	Trans-epidermal water loss (forearm)
Self perceived questionnaire (4 scales)	Day 0 (inclusion), Day 42 (intermediate) and Day 84 (last visit)	Questionnaire (Satisfied, Somewhat satisfied, Somewhat unsatisfied, Unsatisfied)
Skin roughness (mean height - µm)	Day 0 (inclusion) and Day 84 (last visit)	Standardized 3D pictures acquisitions (cheek) and software integration
Skin moisture (%)	Day 0 (inclusion) and Day 84 (last visit)	Reflected electromagnetic probe (forearm)

Trial Locations

Locations (1)

Intertek; 🇫🇷 Paris, France