Clinical trial NCT06254209: Study to Evaluate the Physiological Effects on the Skin of 3 Food Supplements Versus Placebo in 40-60 Years Old Female Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Nexira
Sponsor class: INDUSTRY
First posted: 2024-02-12
Enrollment: 132
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Firmness of the skin
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
Secondary outcomes:
measure: Skin elasticity and tonicity
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Skin density
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Score of fine lines visibility on face, assessed by panelist (trained technician)
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Score of skin radiance of face, assessed by panelist (trained technician)
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Score of nourishing aspect (hydration and quality aspect) of face, assessed by panelist (trained technician)
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Score of skin firmness (tactile pinch of right cheek), assessed by panelist (trained technician)
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Score of skin softness (tactile perception of right cheek), assessed by panelist (trained technician)
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Score of cellulite visibility (right thigh), assessed by panelist (trained technician)
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Dimpled skin - volume (mm3) of humps and dimples
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Dimpled skin - surface (mm2) of humps and dimples
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Skin luminosity - CIELAB (L*a*b)
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Skin color texture - Haralick parameter (contrast & entropy - no unit)
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Skin specular reflectance (spectral reflectance - no unit)
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Skin roughness (mean height - µm)
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Skin barrier function (g/h/m²)
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Skin moisture (%)
timeFrame: Day 0 (inclusion) and Day 84 (last visit)
measure: Self perceived questionnaire (4 scales)
timeFrame: Day 0 (inclusion), Day 42 (intermediate) and Day 84 (last visit)
Other outcomes:
Locations:
city: Paris
country: France
facility: Intertek
Study officials:
References: