Mild to moderate wrinkles/fine lines in crow’s feet area and uneven skin tone (ageing/photoageing spots/redness/acne scars...) Skin and Connective Tissue Diseases
Conditions
Interventions
Three variants of a food supplement containing three different concentrations of the active ingredients (Dermaval™) will be studied.
A quarter of the recruited subjects will take the first formulation
Sponsors
VDF FutureCeuticals INC
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy female subjects 2. Caucasian ethnicity 3. Aged between 35 and 45 years (extreme included) 4. Subjects with BMI between 23.5 and 30 kg/m² 5. Subjects with fasted glucose between 100 and 120 mg/dl (assessed using a portable blood glucose meter) 6. Subjects showing clinical signs of skin ageing: mild to moderate wrinkles/fine lines in crow’s feet area and uneven skin tone (ageing/photoageing spots/redness/acne scars...) 7. Subjects registered with National Health Service (NHS) 8. Subjects certifying the truthfulness of the personal data disclosed to the investigator 9. Subjects able to understand the language used in the investigation center and the information given by the investigator 10. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements 11. Commitment not to change the daily routine or the lifestyle 12. Stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study 13. Subjects undergoing mechanical contraception 14. Subjects informed about the test procedures who have signed a consent form and privacy policy
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator (pharmacological treatments known to interfere with the tested product or having effect on metabolism) 3. Subjects with any acute, chronic, or progressive disease or skin condition that may interfere with the study data or that the investigator considers dangerous to the subject or incompatible with the requirements of the study* 4. Subjects participating or planning to participate in other clinical trials 5. Subjects who participated in a similar study without respecting an adequate washout period (at least month) 6. Subjects that have food intolerances or food allergies or allergy to ingredients of the study product 7. Subjects who are currently using food supplement(s) and/or topical products with the same activity as the study product, or who haven't observed an adequate washout period since stopping use (at least month) 8. Subjects admitted to a health or social facility 9. Subjects planning a hospitalization during the study 10. Subjects not able to be contacted in case of emergency 11. Subjects deprived of freedom by administrative or legal decision or under guardianship 12. Subjects with a history of drug, alcohol and other substance abuse 13. Alimentary/Eating disorders (i.e. bulimia, psychogenic eating disorders, etc.) 14. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study 15. Subjects using or recently withdrawn (less than 30 days) from any hormone-based contraception therapy *Subjects who have unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension and hypotension, diabetes mellitus, kidney failure); subjects with a history of paralysis or cerebral vascular accident; subjects with active cancers or on chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline and after 28 days and 56 days of treatment: 1. Skin elasticity (R2) (Ua/Uf) 2. Skin firmness (R0) (Uf; mm) 3. Trans Epidermal Water Loss (TEWL) (g/h/m2) 4. Skin smoothness (Ra) (µm) 5. Skin roughness (Rz) (µm) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lipidomic analysis on skin stripping: baseline, and after 28 days and 56 days of treatment 2. Proteomic analysis on blood sample: baseline, and after 28 days and 56 days of treatment 3. Metabolomic analysis on blood sample: baseline, and after 28 days and 56 days of treatment (specifically after 28 days+1 and after 56 days+1, i.e., the following morning after 28 and 56 days) 4. Self-evaluation questionnaire: after 56 days 5. Incidence and nature of Adverse Event (AE) and Serious Adverse Event (SAE): after 28 days and 56 days of treatment | — |
Countries
Italy
Contacts
Public ContactRoberta Villa
Outcome results
None listed