Study to Evaluate the Physiological Effects on the Skin of 3 Food Supplements Versus Placebo in 40-60 Years Old Female Subjects
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
1 other identifier
interventional
132
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy-volunteers
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 6, 2023
CompletedFirst Submitted
Initial submission to the registry
December 18, 2023
CompletedFirst Posted
Study publicly available on registry
February 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2024
CompletedApril 1, 2026
May 1, 2025
6 months
December 18, 2023
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Firmness of the skin
Cutometry measurements using Cutometer (cheekbone)
Day 0 (inclusion) and Day 84 (last visit)
Secondary Outcomes (17)
Skin elasticity and tonicity
Day 0 (inclusion) and Day 84 (last visit)
Skin density
Day 0 (inclusion) and Day 84 (last visit)
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 nourishing aspect (hydration and quality aspect) of face, assessed by panelist (trained technician)
Day 0 (inclusion) and Day 84 (last visit)
- +12 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORMaltodextrin
Verum1
EXPERIMENTALCombination of clove (Syzygium aromaticum) and immortelle (Helichrysum italicum) extracts
Verum2
EXPERIMENTALOlive fruit extract (Olea europaea)
Verum3
EXPERIMENTALHibiscus flower extract (Hibiscus sabdariffa)
Interventions
Powder included in capsules for daily administration
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nexiralead
Study Sites (1)
Intertek
Paris, 75013, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2023
First Posted
February 12, 2024
Study Start
November 6, 2023
Primary Completion
May 6, 2024
Study Completion
June 3, 2024
Last Updated
April 1, 2026
Record last verified: 2025-05