Healthy VolunteersNCT06254209
Study to Evaluate the Physiological Effects on the Skin of 3 Food Supplements Versus Placebo in 40-60 Years Old Female Subjects
A study testing Botanicals extracts in people with Healthy Volunteers, run by Nexira at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Botanicals extracts
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2023to 3 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the detailed description
Study design: Monocentric, randomized, double blind, placebo controlled, 3 groups in parallel.
- Conditions
- Healthy Volunteers
- Being tested
- Botanicals extracts, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botanicals extractsDietary supplement
Powder included in capsules for daily administration
PlaceboDietary supplement
Maltodextrin included in capsules for daily administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo |
| Verum1 | Experimental | Combination of clove (Syzygium aromaticum) and immortelle (Helichrysum italicum) extracts Receives: Dietary Supplement: Botanicals extracts |
| Verum2 | Experimental | Olive fruit extract (Olea europaea) Receives: Dietary Supplement: Botanicals extracts |
| Verum3 | Experimental | Hibiscus flower extract (Hibiscus sabdariffa) Receives: Dietary Supplement: Botanicals extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Firmness of the skin
Cutometry measurements using Cutometer (cheekbone)
Measured: Day 0 (inclusion) and Day 84 (last visit)
Secondary outcomes (17)
Skin elasticity and tonicity
Cutometry measurements using the Cutometer (cheekbone)
Measured: Day 0 (inclusion) and Day 84 (last visit)
Skin density
Ultrasound imaging device (lower cheek)
Measured: Day 0 (inclusion) and Day 84 (last visit)
Score of fine lines visibility on face, assessed by panelist (trained technician)
10 points numeric scale: 0 (not visible) to 9 (highly visible)
Measured: Day 0 (inclusion) and Day 84 (last visit)
Score of skin radiance of face, assessed by panelist (trained technician)
10 points numeric scale: 0 (dull) to 9 (radiant)
Measured: Day 0 (inclusion) and Day 84 (last visit)
Score of nourishing aspect (hydration and quality aspect) of face, assessed by panelist (trained technician)
10 points numeric scale: 0 (malnourished) to 9 (nourished)
Measured: Day 0 (inclusion) and Day 84 (last visit)
Score of skin firmness (tactile pinch of right cheek), assessed by panelist (trained technician)
10 points numeric scale: 0 (sagging) to 9 (firm)
Measured: Day 0 (inclusion) and Day 84 (last visit)
Score of skin softness (tactile perception of right cheek), assessed by panelist (trained technician)
10 points numeric scale: 0 (rough) to 9 (soft)
Measured: Day 0 (inclusion) and Day 84 (last visit)
Score of cellulite visibility (right thigh), assessed by panelist (trained technician)
10 points numeric scale: 0 (not visible) to 9 (highly visible)
Measured: Day 0 (inclusion) and Day 84 (last visit)
Dimpled skin - volume (mm3) of humps and dimples
Picture acquisition by fringe projection (on tight) and software integration
Measured: Day 0 (inclusion) and Day 84 (last visit)
Dimpled skin - surface (mm2) of humps and dimples
Picture acquisition by fringe projection (on tight) and software integration
Measured: Day 0 (inclusion) and Day 84 (last visit)
Skin luminosity - CIELAB (L*a*b)
Standardized pictures acquisitions (face) and software integration
Measured: Day 0 (inclusion) and Day 84 (last visit)
Skin color texture - Haralick parameter (contrast & entropy - no unit)
Standardized pictures acquisitions (face) and software integration
Measured: Day 0 (inclusion) and Day 84 (last visit)
Skin specular reflectance (spectral reflectance - no unit)
Standardized pictures acquisitions (face) and software integration
Measured: Day 0 (inclusion) and Day 84 (last visit)
Skin roughness (mean height - µm)
Standardized 3D pictures acquisitions (cheek) and software integration
Measured: Day 0 (inclusion) and Day 84 (last visit)
Skin barrier function (g/h/m²)
Trans-epidermal water loss (forearm)
Measured: Day 0 (inclusion) and Day 84 (last visit)
Skin moisture (%)
Reflected electromagnetic probe (forearm)
Measured: Day 0 (inclusion) and Day 84 (last visit)
Self perceived questionnaire (4 scales)
Questionnaire (Satisfied, Somewhat satisfied, Somewhat unsatisfied, Unsatisfied)
Measured: Day 0 (inclusion), Day 42 (intermediate) and Day 84 (last visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start6 Nov 2023
- Primary completion6 May 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nexira
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254209
- Sponsor's protocol ID
- COS04
- Status last verified
- May 2025
- First submitted
- 18 Dec 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06254209
- Acronym / sponsor ID
- COS04
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- NexiraIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin |
| Verum1 | Experimental | Dietary Supplement: Botanicals extractsCombination of clove (Syzygium aromaticum) and immortelle (Helichrysum italicum) extracts |
| Verum2 | Experimental | Dietary Supplement: Botanicals extractsOlive fruit extract (Olea europaea) |
| Verum3 | Experimental | Dietary Supplement: Botanicals extractsHibiscus flower extract (Hibiscus sabdariffa) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botanicals extractsPowder included in capsules for daily administration | Dietary supplement | Verum1, Verum2, Verum3 |
| PlaceboMaltodextrin included in capsules for daily administration | Dietary supplement | Placebo |
Primary outcome
Firmness of the skin
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Cutometry measurements using Cutometer (cheekbone)
17 secondary outcomes
Skin elasticity and tonicity
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Skin density
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Score of fine lines visibility on face, assessed by panelist (trained technician)
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Score of skin radiance of face, assessed by panelist (trained technician)
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Score of nourishing aspect (hydration and quality aspect) of face, assessed by panelist (trained technician)
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Score of skin firmness (tactile pinch of right cheek), assessed by panelist (trained technician)
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Score of skin softness (tactile perception of right cheek), assessed by panelist (trained technician)
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Score of cellulite visibility (right thigh), assessed by panelist (trained technician)
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Dimpled skin - volume (mm3) of humps and dimples
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Dimpled skin - surface (mm2) of humps and dimples
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Skin luminosity - CIELAB (L*a*b)
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Skin color texture - Haralick parameter (contrast & entropy - no unit)
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Skin specular reflectance (spectral reflectance - no unit)
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Skin roughness (mean height - µm)
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Skin barrier function (g/h/m²)
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Skin moisture (%)
Time frame: Day 0 (inclusion) and Day 84 (last visit)
Self perceived questionnaire (4 scales)
Time frame: Day 0 (inclusion), Day 42 (intermediate) and Day 84 (last visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botanicals extracts in people with Healthy Volunteers, run by Nexira at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Firmness of the skin (time frame: Day 0 (inclusion) and Day 84 (last visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.