Healthy Volunteers
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBotanicals extracts
Powder included in capsules for daily administration
DIETARY_SUPPLEMENTPlacebo
Maltodextrin included in capsules for daily administration
Sponsors
Nexira
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Firmness of the skin | Day 0 (inclusion) and Day 84 (last visit) | Cutometry measurements using Cutometer (cheekbone) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin elasticity and tonicity | Day 0 (inclusion) and Day 84 (last visit) | Cutometry measurements using the Cutometer (cheekbone) |
| Skin density | Day 0 (inclusion) and Day 84 (last visit) | Ultrasound imaging device (lower cheek) |
| 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 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) |
| 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) |
| 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) |
| 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) |
| 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 |
| 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 luminosity - CIELAB (L*a*b) | Day 0 (inclusion) and Day 84 (last visit) | Standardized pictures acquisitions (face) and software integration |
| Skin color texture - Haralick parameter (contrast & entropy - no unit) | Day 0 (inclusion) and Day 84 (last visit) | Standardized pictures acquisitions (face) 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 |
| Skin roughness (mean height - µm) | Day 0 (inclusion) and Day 84 (last visit) | Standardized 3D pictures acquisitions (cheek) and software integration |
| Skin barrier function (g/h/m²) | Day 0 (inclusion) and Day 84 (last visit) | Trans-epidermal water loss (forearm) |
| Skin moisture (%) | Day 0 (inclusion) and Day 84 (last visit) | Reflected electromagnetic probe (forearm) |
| Self perceived questionnaire (4 scales) | Day 0 (inclusion), Day 42 (intermediate) and Day 84 (last visit) | Questionnaire (Satisfied, Somewhat satisfied, Somewhat unsatisfied, Unsatisfied) |
Countries
France
Outcome results
None listed