Healthy subjects with phototype II-IV (according to Fitzpatrick scale), presenting visible Crow’s feet wrinkles, moderate skin slackness and dull complexion . Other
Conditions
Interventions
The active intervention is a food supplement containing Prolastine, while the placebo contains the same excipients without the active ingredient. A restricted randomization list will be generated by a
Sponsors
SAS COPALIS Industrie
Eligibility
Sex/Gender
Female
Age
45 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Good general health 2. Caucasian ethnicity 3. Female sex 4. Age between 45 and 65 years old (extremes included) 5. Subjects with subjects with phototype II-IV (according to Fitzpatrick scale) 6. Subjects presenting visible Crow’s feet wrinkles, moderate skin slackness and dull complexion 7. Subjects who have not been recently involved in any other similar study (evaluation is performed case by case by the experimenter but at least 1 month must be elapsed between a previous study on food supplement) 8. Subjects registered with health social security or health social insurance 9. Subjects having signed their written the Informed Consent Form (ICF) and Privacy Policy for their participation in the study 10. Subjects able to understand the language used in the investigation centre and the information given 11. Subjects able to comply with the protocol and follow protocol constraints and specific requirements 12. Willingness to intake during all the study period only the product to be tested 13. Willingness not to use similar products that could interfere with the product to be tested (e.g. antiaging oral/topic products) 14. Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet etc.) 15. Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial 16. Willingness to avoid direct sun to face during the duration of experiment 17. Willingness to not use tanning beds or other light therapies to face for duration of experiment 18. Willingness to no use of fillers, botox, or lasers during experiment
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Subject is taking part or planning to participate to 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 a sanitary or social facilities 5. Subject who is planning an hospitalization during the study 6. 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, antioxidants compound or anti-inflammatory botanical extracts) 7. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (if women of childbearing potential) 8. 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 9. Subject having an acute, chronic or progressive diseases (e.g. sever 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 10. Subjects under radiotherapy, chemotherapy at any time 11. 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 12. Pharmacological treatments (topic or systemic) known to interfere with skin metabolism/physiology 13. Subjects under locally pharmacological/non-pharmacological treatment applied on the skin area monitored during the test 14. Subject with known or suspected sensitization to one or more test formulation ingredients 15. Subjects considered as not adequate to participate to the study by the investigator 16. Adult protected by law (under control or hospitalized in public or private institutions for reasons other than research, or incarcerated) 17. Subjects not able to communicate or cooperate with the investigator for problems related to language, mental retardation or impaired brain function. 18. Subjects who have used tanning beds or direct sun to the face in the previous 4 weeks 19. Subjects who have used fillers or botox to facial areas in the past 4 or 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin elasticity and firmness measured using a cutometer at baseline and after 28 and 84 days;Wrinkle depth measured using Primos 3D at baseline and after 28 and 84 days;Skin smoothness (Ra parameter) measured using Primos 3D at baseline and after 28 and 84 days;Skin moisturization measured using a corneometer at baseline and after 28 and 84 days;Skin radiance (gloss parameter) measured using a spectrophotometer/colorimeter CM 700D at baseline and after 28 and 84 day;Skin wrinkledness, tonicity, moisturization and radiance measured using clinical internal scales at baseline and after 28 and 84 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermal fibres analysis measured using line-field confocal optical coherence tomography (LC-OCT) at baseline and after 84 days;Efficacy perceived and the pleasantness of the product measured using a self-evaluation questionnaire at 28 and 84 days | — |
Countries
France, Italy
Contacts
Public ContactFrancesca De Gennaro
Outcome results
None listed