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

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

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)

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Botanicals extracts

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Intertek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin	Dietary supplement: Placebo; Maltodextrin included in capsules for daily administration
Experimental: Verum1; Combination of clove (Syzygium aromaticum) and immortelle (Helichrysum italicum) extracts	Dietary supplement: Botanicals extracts; Powder included in capsules for daily administration
Experimental: Verum2; Olive fruit extract (Olea europaea)	Dietary supplement: Botanicals extracts; Powder included in capsules for daily administration
Experimental: Verum3; Hibiscus flower extract (Hibiscus sabdariffa)	Dietary supplement: Botanicals extracts; Powder included in capsules for daily administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Firmness of the skin	Cutometry measurements using Cutometer (cheekbone)	Day 0 (inclusion) and Day 84 (last visit)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nexira

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Actual): May 6, 2024
• Study Completion (Actual): June 3, 2024

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: COS04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No