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Completed

NCT Number: NCT06254209

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)

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Key information

Conditions

Healthy Volunteers

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Intertek

Paris, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botanicals extracts

Dietary Supplement

Powder included in capsules for daily administration

Placebo

Dietary Supplement

Maltodextrin included in capsules for daily administration

Primary outcomes

  1. Firmness of the skin

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

    Cutometry measurements using Cutometer (cheekbone)

Secondary outcomes

  1. Skin elasticity and tonicity

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

    Cutometry measurements using the Cutometer (cheekbone)

  2. Skin density

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

    Ultrasound imaging device (lower cheek)

  3. Score of fine lines visibility on face, assessed by panelist (trained technician)

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

    10 points numeric scale: 0 (not visible) to 9 (highly visible)

  4. Score of skin radiance of face, assessed by panelist (trained technician)

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

    10 points numeric scale: 0 (dull) to 9 (radiant)

  5. Score of nourishing aspect (hydration and quality aspect) of face, assessed by panelist (trained technician)

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

    10 points numeric scale: 0 (malnourished) to 9 (nourished)

  6. Score of skin firmness (tactile pinch of right cheek), assessed by panelist (trained technician)

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

    10 points numeric scale: 0 (sagging) to 9 (firm)

  7. Score of skin softness (tactile perception of right cheek), assessed by panelist (trained technician)

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

    10 points numeric scale: 0 (rough) to 9 (soft)

  8. Score of cellulite visibility (right thigh), assessed by panelist (trained technician)

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

    10 points numeric scale: 0 (not visible) to 9 (highly visible)

  9. Dimpled skin - volume (mm3) of humps and dimples

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

    Picture acquisition by fringe projection (on tight) and software integration

  10. Dimpled skin - surface (mm2) of humps and dimples

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

    Picture acquisition by fringe projection (on tight) and software integration

  11. Skin luminosity - CIELAB (L*a*b)

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

    Standardized pictures acquisitions (face) and software integration

  12. Skin color texture - Haralick parameter (contrast & entropy - no unit)

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

    Standardized pictures acquisitions (face) and software integration

  13. Skin specular reflectance (spectral reflectance - no unit)

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

    Standardized pictures acquisitions (face) and software integration

  14. Skin roughness (mean height - µm)

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

    Standardized 3D pictures acquisitions (cheek) and software integration

  15. Skin barrier function (g/h/m²)

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

    Trans-epidermal water loss (forearm)

  16. Skin moisture (%)

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

    Reflected electromagnetic probe (forearm)

  17. Self perceived questionnaire (4 scales)

    Time frame: Day 0 (inclusion), Day 42 (intermediate) and Day 84 (last visit)

    Questionnaire (Satisfied, Somewhat satisfied, Somewhat unsatisfied, Unsatisfied)

Sponsors and collaborators

Lead sponsor

Nexira

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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