Subjects showing visible Crow’s feet wrinkles Not Applicable
Conditions
Interventions
Active and placebo food supplements are manufactured according to the applicable national and international rules and regulations. All ingredients included in the active and placebo formulas are appro
Sponsors
SynBalance srl
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy Caucasian female (50%) and male (50%) subjects 2. Aged between 38 and 67 (extremes included) years old 3. Subjects showing visible Crow’s feet wrinkles (=2 according to Skin Aging Atlas – Caucasian Type - Bazin Roland) 4. Subjects with normal to dry skin 5. Subjects who have not been recently involved in any other similar study 6. Willingness to use during the study period only the product to be tested 7. Subjects certifying the truthfulness of the personal data disclosed to the investigator 8. Subjects able to understand the language used in the investigation center and the information given by the investigator 9. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements 10. The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study 11. Commitment not to change the daily routine or the lifestyle 12. Subjects have signed their written Informed Consent form (ICF) and privacy form for their participation in the study and a photograph authorization
Exclusion criteria
Exclusion criteria: 1. Those who do not fit the inclusion criteria 2. Individuals participating or planning to participate in other clinical trials 3. Persons deprived of freedom by administrative or legal decision or under guardianship 4. Individuals not able to be contacted in case of emergency 5. Persons admitted to a health or social facility 6. Individuals planning a hospitalization during the study 7. Participants who participated in a similar study without respecting an adequate washout period 8. Individuals having an acute, chronic, or progressive illness liable to interfere with the study data or considered by the investigator hazardous or incompatible with the study requirements 9. Persons with known hypersensitivity or allergy to one of the active ingredients 10. Individuals under pharmacological treatments that are considered incompatible with the study requirements by the investigator 11. Persons having a skin disease or condition liable to interfere with the study data or considered by the investigator hazardous or incompatible with the study requirements 12. Individuals that have shown allergies or sensitivity to cosmetic and/or probiotic products, drugs, patch, or medical devices 13. Women who are breastfeeding, pregnant, or not willing to take necessary precautions to avoid pregnancy during the study (for women of childbearing potential) 14. Individuals consuming food supplements containing probiotics and/or for skin care currently or within the past 4 weeks before the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The antiaging efficacy of the tested treatment was evaluated using the following: 1. Skin profilometry (wrinkledness) measured using Primos 3D (GFMesstechnik GmbH) at baseline (T0), T28, T56, T84. 2. Dermis+ epidermis thickness and dermis density measured using high-frequency ultrasound imaging (DUB® Skin Scanner System) at T0, T56, and T84 3. Skin moisturization measured using a CORNEOMETER® (Courage+Khazaka, electronic GmbH) at T0,T28, T56, T84 4. Skin-deep moisturization measured using the MoistureMeterEpiD (Delfin Technologies) at T0, T56, T84 5. Transepidermal water loss measured using a Tewameter 300® (Courage+Khazaka, electronic GmbH) at T0,T28, T56, T84 6. Digital pictures acquired by means of Visia®-CR (Canfield Scientific) at T0, T28, T56, T84 7. Clinical evaluation of skin wrinkledness carried out by the experimenter according to an internal clinical scale (0. No wrinkle; 1. Barely visible; 2. Visible; 3. Moderately visible; 4. Evident; 5. Very evident; 6. Marked; 7. Very marked) at T0, T28, T56, T84 8. Clinical evaluation of skin radiance carried out by the experimenter according to an internal clinical scale (1. Very dull skin; 2. Moderately dull skin; 3. Slightly dull skin; 4. Sufficiently bright skin; 5. Very bright skin), at T0, T28, T56, T84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total skin antioxidant capacity measured using the FRAP assay on skin-stripping at T0 and T56 2. Evaluations of cytokines concentration (TNF-alpha cytokines) measured using an ELISA assay on skin-stripping at T0 and T56 3. Product acceptability and volunteers’ perceived efficacy measured using a self-assessment questionnaire at T56 4. Product safety measured using adverse events recording throughout the study (T28 and T56) | — |
Countries
Italy
Contacts
Public ContactIleana De Ponti
Outcome results
None listed