Skin AgeingISOSKINNCT06047145
Evaluation of Soy Isoflavones on Skin Ageing Parameters
A study testing soy isoflavones in people with Skin Ageing, run by The Archer-Daniels-Midland Company at 1 site in France.
Trial summary
This double-blind, placebo-controlled, randomised pilot trial aims to assess the effect of oral soy isoflavone consumption on skin ageing parameters in post-menopausal women. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Ageing
- What is being tested?
- soy isoflavones
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2023to 26 Feb 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject.
- Sex: female.
- Age: from 40 to 65 years (inclusive).
- Phototype: I to IV on the Fitzpatrick scale.
- Post-menopausal subject, with last menstrual period at least 12 months prior to screening and who is not using hormonal contraception.
- Subject having Crow's feet wrinkles from grade 2 to 5 on Bazin's scale.
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- Subject having under eyes wrinkles.
- Subject agreeing not to change her alimentary and cosmetic habits during the study.
- Subject, able to understand the study related information and to give a written informed consent.
- Subject having given freely and expressly informed consent.
- Subject able and willing to comply with protocol requirements.
- Subject affiliated to a health social security system.
Who cannot join
- Women with childbearing potential or women on long term hormonal contraception whose childbearing potential is difficult to ascertain.
- Subject deprived of her freedom by administrative or legal decision.
- Subject under guardianship or unable to provide consent.
- Subject in a social or healthcare institution.
- Subject suspected to be non-compliant according to the investigator's judgment.
- Subject participating in any other clinical study or being in an exclusion period for a previous study.
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- Subject having crow's feet wrinkles with grades < 2 or > 5 on Bazin's scale.
- Subject with a tattoo, a scar, moles, too many hairs or anything on the studied zones which might interfere with the evaluation.
- Personal or family history of breast, uterine or ovarian cancer as per investigator judgement.
- Subject with personal history of cancer.
- Subject with a condition or receiving a medication which, in the investigator's judgement, put the subject at undue risk.
- Subject suffering from a severe or progressive disease, likely to interfere with the measured parameters.
- Subject with any skin or systemic disease (acute and/or chronic), ongoing or in the previous year, likely to interfere with the measured parameters or to put the subject at undue risk.
- Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
- Subject with allergies or intolerance to soy or soy products.
- Subject having history of allergy or hypersensitivity to any of the components of the tested product.
- Subject under anti-coagulant treatment.
- Subject under thyroid hormones treatment.
- Subject under osteoporosis treatment other than vitamin D and calcium.
- Subject having started or stopped supplements used to treat menopausal symptoms, which may affect measured parameters, such as phytoestrogens, Black Cohosh, dehydroepiandrosterone (DHEA), hyaluronic acid, collagen, NADH, resveratrol soy supplements, etc. within one month prior to screening.
- Subject having received injection with botulinum toxin on Crow's feet wrinkles in the year before the screening visit.
- Subject having received injection with botulinum toxin on other zone of the face in the past 6 months before the screening visit.
- Subject having received injection of filling product on the studied zones (crow's feet and under eye wrinkles, cheekbones and forearms) in the year before the screening visit.
- Subject having received tensor threads on the face in the two years before the screening visit.
- Subject having received injection of mesotherapy in the face in the past 3 months before the screening visit.
- Subject having received professional peeling on the face and forearms in the past 3 months before the screening visit.
- Subject having received a treatment with a laser on the face or forearms in the past 6 months before the screening visit.
- Subject under oral hormonal substitutive treatment during the year previous the screening visit.
- Subject receiving any long-term medical treatment or any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject at undue risk.
- Subject undergoing a topical treatment on the test area (forearms and face) or a systemic treatment:
- corticosteroids during the 2 previous weeks and during the study.
- retinoids and/or immunosuppressors during the 3 previous months and during the study.
- Intensive exposure to sunlight within the previous month and foreseen during the study without adequate sun protection, as per the investigator's judgement.
- Exposure to artificial UV or spray tan in the month preceding the screening or during the study.
- Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Oral Soy Isoflavone Concentrates on Skin Ageing Parameters: a Double-blind Randomised Placebo-controlled Trial
This double-blind, placebo-controlled, randomised pilot trial aims to assess the effect of oral soy isoflavone consumption on skin ageing parameters in post-menopausal women.
- Conditions
- Skin Ageing
- Being tested
- soy isoflavones, Placebo
- Keywords
- soy isoflavones, skin ageing, menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy isoflavonesDietary supplement
1 capsule daily for 84 days
PlaceboDietary supplement
1 capsule daily for 84 days
| Study group | Role | What they receive |
|---|---|---|
| soy isoflavones | Experimental | One oral capsule daily containing 200mg soy isoflavones for 84 days Receives: Dietary Supplement: soy isoflavones |
| placebo | Placebo comparator | One oral capsule daily containing equivalent placebo for 84 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Crow's Feet wrinkles (Ra)
Cutaneous relief parameters (Ra - Average roughness) on Crow's Feet wrinkles measured with fringe projection acquisitions
Measured: day 0, day 84
Secondary outcomes (11)
Change in Crow's Feet wrinkles (Ra)
Cutaneous relief parameters (Ra - Average roughness) on Crow's Feet wrinkles measured with fringe projection acquisitions
Measured: day 0, day 42
Change in Crow's Feet wrinkles (Rz)
Cutaneous relief parameters (Rz - Average height of the roughness) on Crow's Feet wrinkles measured with fringe projection acquisitions
Measured: day 0, day 42, day 84
Change in Crow's Feet wrinkles (Rt)
Cutaneous relief parameters (Rt - Maximum height of the roughness profile) on Crow's Feet wrinkles measured with fringe projection acquisitions
Measured: day 0, day 42, day 84
Change in under eye wrinkles (Ra)
Cutaneous relief parameters (Ra - Average roughness) on under eye wrinkles measured with fringe projection acquisitions
Measured: day 0, day 42, day 84
Change in under eye wrinkles (Rt)
Cutaneous relief parameters (Rt - Maximum height of the roughness profile) on under eye wrinkles measured with fringe projection acquisitions
Measured: day 0, day 42, day 84
Change in under eye wrinkles (Rz)
Cutaneous relief parameters (Rz - Average height of the roughness) on under eye wrinkles measured with fringe projection acquisitions
Measured: day 0, day 42, day 84
Change in skin hydration
Skin hydration will be evaluated by Corneometer® on the forearm.
Measured: day 0, day 42, day 84
Change in skin colour
Skin colour will be evaluated by Spectrophotometer® on the cheekbone.
Measured: day 0, day 42, day 84
Change in skin barrier function
Skin barrier function will be evaluated by the measurement of Trans Epidermal Water Loss with Aquaflux® on the forearm
Measured: day 0, day 42, day 84
Subject satisfaction
A non-validated subjective evaluation questionnaire on the study product's effects on the skin will be completed by subjects (each item is scored individually on a 5 point Likert scale ranging from 'Totally agree' to 'Totally disagree')
Measured: day 42, day 84
Adverse events
Collection of adverse events throughout the study
Measured: day 0, day 42, day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start27 Oct 2023
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin AgeingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047145
- Sponsor's protocol ID
- CTB2022TN110
- Acronym
- ISOSKIN
- Status last verified
- Mar 2024
- First submitted
- 5 Sep 2023
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vijayakumar V, Climent E, Enrique M, Lamelas A, Alvarez B, Chenoll E, Naghibi M, Day R. S-equol status modulates skin response to soy isoflavones in postmenopausal women: results from a randomized placebo-controlled pilot trial. Front Nutr. 2025 Nov 3;12:1671835. doi: 10.3389/fnut.2025.1671835. eCollection 2025.
PubMed 41256931
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Soy Isoflavone Concentrates on Skin Ageing Parameters: a Double-blind Randomised Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06047145
- Acronym / sponsor ID
- ISOSKIN / CTB2022TN110
- Conditions
- Skin Ageing
- Keywords
- soy isoflavones, skin ageing, menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 21 Sep 2023 (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.
This double-blind, placebo-controlled, randomised pilot trial aims to assess the effect of oral soy isoflavone consumption on skin ageing parameters in post-menopausal women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| soy isoflavones | Experimental | Dietary Supplement: soy isoflavonesOne oral capsule daily containing 200mg soy isoflavones for 84 days |
| placebo | Placebo comparator | Dietary Supplement: PlaceboOne oral capsule daily containing equivalent placebo for 84 days |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy subject.
- Sex: female.
- Age: from 40 to 65 years (inclusive).
- Phototype: I to IV on the Fitzpatrick scale.
- Post-menopausal subject, with last menstrual period at least 12 months prior to screening and who is not using hormonal contraception.
Key exclusion criteria (35 listed)
- Women with childbearing potential or women on long term hormonal contraception whose childbearing potential is difficult to ascertain.
- Subject deprived of her freedom by administrative or legal decision.
- Subject under guardianship or unable to provide consent.
- Subject in a social or healthcare institution.
- Subject suspected to be non-compliant according to the investigator's judgment.
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 |
|---|---|---|
| soy isoflavones1 capsule daily for 84 days | Dietary supplement | soy isoflavones |
| Placebo1 capsule daily for 84 days | Dietary supplement | placebo |
Primary outcome
Change in Crow's Feet wrinkles (Ra)
Time frame: day 0, day 84
Cutaneous relief parameters (Ra - Average roughness) on Crow's Feet wrinkles measured with fringe projection acquisitions
11 secondary outcomes
Change in Crow's Feet wrinkles (Ra)
Time frame: day 0, day 42
Change in Crow's Feet wrinkles (Rz)
Time frame: day 0, day 42, day 84
Change in Crow's Feet wrinkles (Rt)
Time frame: day 0, day 42, day 84
Change in under eye wrinkles (Ra)
Time frame: day 0, day 42, day 84
Change in under eye wrinkles (Rt)
Time frame: day 0, day 42, day 84
Change in under eye wrinkles (Rz)
Time frame: day 0, day 42, day 84
Change in skin hydration
Time frame: day 0, day 42, day 84
Change in skin colour
Time frame: day 0, day 42, day 84
Change in skin barrier function
Time frame: day 0, day 42, day 84
Subject satisfaction
Time frame: day 42, day 84
Adverse events
Time frame: day 0, day 42, day 84
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 10 Apr 2025.
- Derived from this study: PubMed 41256931Vijayakumar V, Climent E, Enrique M, Lamelas A, Alvarez B, Chenoll E, Naghibi M, Day R. S-equol status modulates skin response to soy isoflavones in postmenopausal women: results from a randomized placebo-controlled pilot trial. Front Nutr. 2025 Nov 3;12:1671835. doi: 10.3389/fnut.2025.1671835. eCollection 2025.
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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 soy isoflavones in people with Skin Ageing, run by The Archer-Daniels-Midland Company 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 12 inclusion and 35 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 10 Apr 2025. 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?
Change in Crow's Feet wrinkles (Ra) (time frame: day 0, day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06047145, which also lists 1 linked publication.
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 10 Apr 2025.