Evaluation of Soy Isoflavones on Skin Ageing Parameters (ISOSKIN)

April 8, 2025 updated by: The Archer-Daniels-Midland Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Villeurbanne, France
        • Eurofins DERMSCAN PHARMASCAN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy subject.
  2. Sex: female.
  3. Age: from 40 to 65 years (inclusive).
  4. Phototype: I to IV on the Fitzpatrick scale.
  5. Post-menopausal subject, with last menstrual period at least 12 months prior to screening and who is not using hormonal contraception.
  6. Subject having Crow's feet wrinkles from grade 2 to 5 on Bazin's scale.
  7. Subject having under eyes wrinkles.
  8. Subject agreeing not to change her alimentary and cosmetic habits during the study.
  9. Subject, able to understand the study related information and to give a written informed consent.
  10. Subject having given freely and expressly informed consent.
  11. Subject able and willing to comply with protocol requirements.
  12. Subject affiliated to a health social security system.

Exclusion Criteria:

  1. Women with childbearing potential or women on long term hormonal contraception whose childbearing potential is difficult to ascertain.
  2. Subject deprived of her freedom by administrative or legal decision.
  3. Subject under guardianship or unable to provide consent.
  4. Subject in a social or healthcare institution.
  5. Subject suspected to be non-compliant according to the investigator's judgment.
  6. Subject participating in any other clinical study or being in an exclusion period for a previous study.
  7. Subject having crow's feet wrinkles with grades < 2 or > 5 on Bazin's scale.
  8. Subject with a tattoo, a scar, moles, too many hairs or anything on the studied zones which might interfere with the evaluation.
  9. Personal or family history of breast, uterine or ovarian cancer as per investigator judgement.
  10. Subject with personal history of cancer.
  11. Subject with a condition or receiving a medication which, in the investigator's judgement, put the subject at undue risk.
  12. Subject suffering from a severe or progressive disease, likely to interfere with the measured parameters.
  13. 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.
  14. Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
  15. Subject with allergies or intolerance to soy or soy products.
  16. Subject having history of allergy or hypersensitivity to any of the components of the tested product.
  17. Subject under anti-coagulant treatment.
  18. Subject under thyroid hormones treatment.
  19. Subject under osteoporosis treatment other than vitamin D and calcium.
  20. 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.
  21. Subject having received injection with botulinum toxin on Crow's feet wrinkles in the year before the screening visit.
  22. Subject having received injection with botulinum toxin on other zone of the face in the past 6 months before the screening visit.
  23. 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.
  24. Subject having received tensor threads on the face in the two years before the screening visit.
  25. Subject having received injection of mesotherapy in the face in the past 3 months before the screening visit.
  26. Subject having received professional peeling on the face and forearms in the past 3 months before the screening visit.
  27. Subject having received a treatment with a laser on the face or forearms in the past 6 months before the screening visit.
  28. Subject under oral hormonal substitutive treatment during the year previous the screening visit.
  29. 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.

  30. 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.
  31. Intensive exposure to sunlight within the previous month and foreseen during the study without adequate sun protection, as per the investigator's judgement.
  32. Exposure to artificial UV or spray tan in the month preceding the screening or during the study.
  33. Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: soy isoflavones
One oral capsule daily containing 200mg soy isoflavones for 84 days
Dietary supplement: soy isoflavones
1 capsule daily for 84 days
Placebo Comparator: placebo
One oral capsule daily containing equivalent placebo for 84 days
Dietary supplement: Placebo
1 capsule daily for 84 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
day 0, day 84

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Crow's Feet wrinkles (Ra)
Time Frame: day 0, day 42
Cutaneous relief parameters (Ra - Average roughness) on Crow's Feet wrinkles measured with fringe projection acquisitions
day 0, day 42
Change in Crow's Feet wrinkles (Rz)
Time Frame: day 0, day 42, day 84
Cutaneous relief parameters (Rz - Average height of the roughness) on Crow's Feet wrinkles measured with fringe projection acquisitions
day 0, day 42, day 84
Change in Crow's Feet wrinkles (Rt)
Time Frame: day 0, day 42, day 84
Cutaneous relief parameters (Rt - Maximum height of the roughness profile) on Crow's Feet wrinkles measured with fringe projection acquisitions
day 0, day 42, day 84
Change in under eye wrinkles (Ra)
Time Frame: day 0, day 42, day 84
Cutaneous relief parameters (Ra - Average roughness) on under eye wrinkles measured with fringe projection acquisitions
day 0, day 42, day 84
Change in under eye wrinkles (Rt)
Time Frame: day 0, day 42, day 84
Cutaneous relief parameters (Rt - Maximum height of the roughness profile) on under eye wrinkles measured with fringe projection acquisitions
day 0, day 42, day 84
Change in under eye wrinkles (Rz)
Time Frame: day 0, day 42, day 84
Cutaneous relief parameters (Rz - Average height of the roughness) on under eye wrinkles measured with fringe projection acquisitions
day 0, day 42, day 84
Change in skin hydration
Time Frame: day 0, day 42, day 84
Skin hydration will be evaluated by Corneometer® on the forearm.
day 0, day 42, day 84
Change in skin colour
Time Frame: day 0, day 42, day 84
Skin colour will be evaluated by Spectrophotometer® on the cheekbone.
day 0, day 42, day 84
Change in skin barrier function
Time Frame: day 0, day 42, day 84
Skin barrier function will be evaluated by the measurement of Trans Epidermal Water Loss with Aquaflux® on the forearm
day 0, day 42, day 84
Subject satisfaction
Time Frame: day 42, day 84
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')
day 42, day 84
Adverse events
Time Frame: day 0, day 42, day 84
Collection of adverse events throughout the study
day 0, day 42, day 84

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urinary isoflavones and metabolites
Time Frame: day 0, day 42, day 84
To quantify levels of key isoflavones and metabolites in urine
day 0, day 42, day 84
Equol-producing status
Time Frame: day 0, day 42, day 84
To identify equol-producing individuals based on urine levels of equol
day 0, day 42, day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Archer-Daniels-Midland Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eurofins Dermscan Pharmascan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTB2022TN110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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