Evaluation of Soy Isoflavones on Skin Ageing Parameters (ISOSKIN)

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: Completed
• Conditions: Skin Ageing
• Intervention / Treatment: Dietary supplement: soy isoflavones; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ADM Medical Team; Phone Number: +44 1460 243 20; Email: medical@protexin.com

Study Locations

• France
  • Villeurbanne, France
    • Eurofins Dermscan Pharmascan
    • Contact: Manon Laune; Phone Number: 4409 +33 (0)4 72 82 36 56; Email: mla@dermscan.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Crow's Feet wrinkles (Ra)	Cutaneous relief parameters (Ra - Average roughness) on Crow's Feet wrinkles measured with fringe projection acquisitions	day 0, day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Crow's Feet wrinkles (Ra)	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)	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)	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)	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)	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)	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	Skin hydration will be evaluated by Corneometer® on the forearm.	day 0, day 42, day 84
Change in skin colour	Skin colour will be evaluated by Spectrophotometer® on the cheekbone.	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	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')	day 42, day 84
Adverse events	Collection of adverse events throughout the study	day 0, day 42, day 84

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary isoflavones and metabolites	To quantify levels of key isoflavones and metabolites in urine	day 0, day 42, day 84
Equol-producing status	To identify equol-producing individuals based on urine levels of equol	day 0, day 42, day 84

Collaborators and Investigators

• Sponsor: The Archer-Daniels-Midland Company
• Collaborators: Eurofins Dermscan Pharmascan

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Actual): February 26, 2024
• Study Completion (Actual): February 26, 2024

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: menopause; soy isoflavones; skin ageing
• Other Study ID 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