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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254209
• Other study ID #: COS04
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: April 2024

Study information

• Verified date: February 2024
• Source: Nexira
• Contact: Damien Guillemet
• Phone: +33232831818
• Email: d.guillemet[@]nexira.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Botanicals extracts
Powder included in capsules for daily administration
• Placebo
Maltodextrin included in capsules for daily administration

Locations

Country	Name	City	State
France	Intertek	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nexira

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Firmness of the skin	Cutometry measurements using Cutometer (cheekbone)	Day 0 (inclusion) and Day 84 (last visit)
Secondary	Skin elasticity and tonicity	Cutometry measurements using the Cutometer (cheekbone)	Day 0 (inclusion) and Day 84 (last visit)
Secondary	Skin density	Ultrasound imaging device (lower cheek)	Day 0 (inclusion) and Day 84 (last visit)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Skin luminosity - CIELAB (L*a*b)	Standardized pictures acquisitions (face) and software integration	Day 0 (inclusion) and Day 84 (last visit)
Secondary	Skin color texture - Haralick parameter (contrast & entropy - no unit)	Standardized pictures acquisitions (face) and software integration	Day 0 (inclusion) and Day 84 (last visit)
Secondary	Skin specular reflectance (spectral reflectance - no unit)	Standardized pictures acquisitions (face) and software integration	Day 0 (inclusion) and Day 84 (last visit)
Secondary	Skin roughness (mean height - µm)	Standardized 3D pictures acquisitions (cheek) and software integration	Day 0 (inclusion) and Day 84 (last visit)
Secondary	Skin barrier function (g/h/m²)	Trans-epidermal water loss (forearm)	Day 0 (inclusion) and Day 84 (last visit)
Secondary	Skin moisture (%)	Reflected electromagnetic probe (forearm)	Day 0 (inclusion) and Day 84 (last visit)
Secondary	Self perceived questionnaire (4 scales)	Questionnaire (Satisfied, Somewhat satisfied, Somewhat unsatisfied, Unsatisfied)	Day 0 (inclusion), Day 42 (intermediate) and Day 84 (last visit)