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
• Interventions: Dietary Supplement: Botanicals extracts; Dietary Supplement: Placebo

• 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

Arm && Interventions

Group	Intervention	Description
Verum2	Botanicals extracts	Olive fruit extract (Olea europaea)
Placebo	Placebo	Maltodextrin
Verum3	Botanicals extracts	Hibiscus flower extract (Hibiscus sabdariffa)
Verum1	Botanicals extracts	Combination of clove (Syzygium aromaticum) and immortelle (Helichrysum italicum) extracts

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