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Clinical Trials/NCT06254209
NCT06254209RecruitingNot Applicable

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

Nexira2 sites in 1 country132 target enrollmentStarted: November 6, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Nexira
Enrollment
132
Locations
2
Primary Endpoint
Firmness of the skin
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Outcomes

Primary Outcomes

Firmness of the skin

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

Cutometry measurements using Cutometer (cheekbone)

Secondary Outcomes

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

Investigators

Sponsor
Nexira
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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