Healthy female subjects between 45 and 65 years of age, Fitzpatrick skin type I – III, with aging signs Other
Conditions
Interventions
Subjects take 3 food supplement tablets once daily for 3 months at home in the morning, drinking 1 cup of water during intake if necessary. In case intake was forgotten, the subjects shall not take th
Sponsors
L'Oréal / CAI VICHY
Eligibility
Sex/Gender
Female
Age
45 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent to participate in the study and to allow photo usage for illustrative and/or research purposes 2. Willingness to actively participate in the study and to come to the scheduled visits 3. Healthy subjects (according to investigator or designee) 4. Female 5. Caucasian 6. From 45 to 65 years of age 7. Menopausal* (from 1 year to 10 years) *Menopausal = women having at least 1 year without menstruation 8. Pre-menopausal with first symptoms of the menopause (e.g. hot flashes, irregular menstruation, intensity of menstruation flow, mood changes, myalgia, headaches, insomnia, etc) 9. BMI (body mass index) = 20 and = 30 kg/m2 10. Skin firmness = 3 and = 6 on the cheeks (on a 10 points scale) 11. Phototype I, II or III 12. Nail length of at least 4 mm 13. Hair length of at least 2 cm 14. Pre-menopausal females: using adequate contraception (implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomised partner, cosexual partner, condom) 15. Preferably subjects with no cigarette consumption or 1-2 cigarettes a week, if necessary smoker but with no increase of the cigarette consumption will be accepted to complete the panel 16. Preferably, subjects with no alcohol consumption or 1-2 glasses a week , if necessary subjects with no increase of the alcohol consumption will be accepted to complete the panel 17. Menopausal females: Preferably, subjects with no hormonal replacement therapy, if necessary subjects with no beginning or modification of hormonal replacement therapy will be accepted to complete the panel
Exclusion criteria
Exclusion criteria: Nutrition 1. Documented allergies to food supplements and/or ingredients, to eggs 2. Intake of own food supplements (including vitamins and minerals) or other active compounds which may have an effect on skin 2 months prior to the start of the study and throughout the entire course of the study (excluding food supplements provided during the study) 3. Modification of weight of more than 5 kg 2 months prior to the start of the study Habits and practices 1. Drug addicts, alcoholics 2. Application of self-tanning products on the test area 4 weeks prior to the start of the study and/or throughout the entire course of the study 3. Nail biting habit 4. Employee of the study site 5. Aesthetic procedures (such as chemical peeling, lasers, dermabrasions, injections, anti-ageing mask, hair implant etc ….) performed in beauty salon or in medical offices at the test areas to be measured / assessed that could influence the investigation for 6 months prior to the start of the study 6. Application of peeling products at home on the test area 4 weeks prior to the start of the study and/or throughout the entire course of the study 7. Application of depigmenting cosmetic products and / or retinol based-cosmetics (or derivative), vitamin C based-cosmetic (or derivative) or AHA based-cosmetic on the evaluation areas 4 weeks prior to the start of the study and/or throughout the entire course of the study 8. Excessive sun exposure (natural or artificial - thus/visibly tanned) on the concerned areas 4 weeks prior to the start of the study and/or throughout the entire course of the study 9. Anti-aging cosmetic products and/or cosmetic products claiming efficacy on the skin firmness and wrinkles on the evaluation areas 2 weeks prior to the start of the study and/or throughout the entire course of the study 10. Visit the sauna or hammam 2 weeks prior to the start of the study Hormonal status Pre-menopausal females: Planned start or modification of oestro-progestogen treatment during the course of the study Global condition and health 1. Pre-menopausal females: Pregnancy or lactation 2. AIDS, HIV-positive or infectious hepatitis 3. Conditions which exclude a participation or might influence the test reaction/evaluation 4. Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area 5. Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years 6. One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases 7. Insulin-dependent diabetes mellitus 8. Active skin disease on the head, hands, thigh and volar forearms like acute dermatitis, that requires actual topical medication on the test area and/or systemic drug treatment according to a physician 9. Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test areas to be measured / assessed that could influence the investigation 10. Epilepsy 11. Chronic gastrointestinal diseases 12. Application of a treatment (oral or topical) with tretinoin or isotretinoin or corticosteroid 8 weeks prior to the start of the study and/or throughout the entire course of the study 13. Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) throughout the entire course of the study 14. Systemic long-term therapy with anti-phlogistic agent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The skin firmness is measured using a Visual Analogue Scale (VAS) at baseline and after 1 and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures were assessed at baseline and after 1 and 3 months: 1. Skin smoothness, elasticity and tonicity measured using a Visual Analogue Scale (VAS) 2. Wrinkles measured using the Atlas scale and AEVA 3. Hair thickness measured using TrichoLAB 4. Nail strength measured using Nail StrainStress Meter 5. Skin elasticity, firmness and viscoelasticity measured using a cutometer 6. Skin hydration measured using a corneometer 7. Skin density measured using ultrasound 8. Standardized pictures taken with Visia CR 10. Efficacy and tolerance were measured using a questionnaire after 1 and 3 months | — |
Countries
Germany
Contacts
Public ContactJulie Faure
Outcome results
None listed