Healthy volunteers showing dry face skin, lack of skin elasticity and firmness and showing mild to moderate wrinkles in the crow’s feet area Skin and Connective Tissue Diseases
Conditions
Interventions
The active intervention is a food supplment containg Centella Phytosome™. The formulation contains a dry extract of Centella asiatica (L.) Urban (leaves) combined with sunflower lecithin, while the pl
Sponsors
INDENA S.P.A
Eligibility
Sex/Gender
Female
Age
45 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Good general health. 2. Caucasian ethnicity. 3. Female sex. 4. Age between 45 and 60 years old (extremes included). 5. Subjects with dry face skin, lack of skin elasticity and firmness and showing mild to moderate wrinkles in the crow’s feet area. 6. Subjects who have not been recently involved in any other similar study (evaluation is performed case by case by the Investigator but at least 1 month must be elapsed between a previous study on food supplement). 7. Subjects registered with health social security or health social insurance. 8. Subjects having signed their written the Informed Consent Form (ICF) and Privacy Policy for their participation in the study. 9. Subjects able to understand the language used in the investigation centre and the information given. 10. Subjects able to comply with the protocol and follow protocol constraints and specific requirements. 11. Willingness to use during all the study period only the product to be tested. 12. Willingness not to use similar products that could interfere with the product to be tested (e.g. antiaging oral/topic products). 13. Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet etc.). 14. Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial.
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria. 2. Subject is taking part or planning to participate in another clinical study in the same or in another investigation centre. 3. Subject who is deprived of freedom by administrative or legal decision or under guardianship. 4. Subject admitted in sanitary or social facilities. 5. Subjects under treatment with food supplements which could interfere with the functionality of the product under study (e.g., supplements containing collagen peptides, hyaluronic acid, antioxidant compounds or anti-inflammatory botanical extracts). 6. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (if women of childbearing potential). 7. Subject has started or changed estrogen-progesterone contraception or hormonal treatment within the 3 months prior to the study or foreseeing it for the duration of the study. 8. Subject having acute, chronic or progressive diseases (e.g., severe atopic dermatitis, psoriasis) liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements. 9. Subjects under radiotherapy or chemotherapy at any time. 10. Subject having a skin condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements. 11. Pharmacological treatments (topical or systemic) known to interfere with skin metabolism/physiology. 12. Subjects under locally pharmacological or non-pharmacological treatment applied on the skin area monitored during the test. 13. Subject with known or suspected sensitization to one or more test formulation ingredients. 14. Subjects considered not adequate to participate in the study by the Investigator. 15. Adult protected by law (under control or hospitalized in public or private institutions for reasons other than research, or incarcerated). 16. Subjects not able to communicate or cooperate with the Investigator due to language problems, mental retardation, or impaired brain function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin elasticity measured using Cutometer® (Courage + Khazaka electronic GmbH) method (suction and elongation) at baseline and after 28 and 84 days.;Skin profilometry measured using Primos CR-SF (Canfield Scientific) 3D imaging (fringe projection) at baseline and after 28 and 84 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Epidermis thickness and dermal fiber analysis measured using Line field Confocal Optical Coherence Tomography (LC-OCT) technology (DAMAE Medical) at baseline and after 28 and 84 days.;In situ evaluations measured using the cytokine dosage (ELISA) and FRAP (Ferric reducing anti oxidant potential) assay on skin strippings (stratum corneum) taken by Corneofix® (Courage + Khazaka electronic GmbH) at baseline and after 84 days.;Personal opinion on the tested product measured using self-assessment questionnaire at after 28 and 84 days.;Evaluation of the “younger skin” effect measured using mean value of periocular wrinkle depth variation at baseline and after 28 and 84 days. | — |
Countries
France, Italy
Contacts
Public ContactEleonora;Jessica Spartà;Lacetera
;
Outcome results
None listed