Mild-to-moderate skin aging Skin and Connective Tissue Diseases
Conditions
Interventions
while the placebo intervention was maltodextrin. Both the active and the placebo products were used as follows: one capsule per day intake at breakfast for 56 days.
Half of the test subjects were ran
Sponsors
BIONAP srl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female and male healthy subjects (between 30-50% male and 50-70% female) 2. 35 = age = 65 years old 3. 40% Caucasian (skin phototype* I to III) and 60% Asian (skin phototype* III to V) ethnicity 4. Mild to moderate skin aging sign including dark spots (grade 2-4; Skin Aging Atlas by Bazin R.) 5. Registration with health social security or health social insurance (if required by national regulations) 6. Promise to not use during all the study period topic products/food supplements with similar effect to that one of the product to be tested (antioxidant) 7. Commitment to sign the informed consent form (ICF) 8. Truthfulness of the personal information declared to the Investigator 9. Ability to understand the language used in the investigation centre and the information given 10. No recent participation in any other similar study 11. No sun exposure (both natural and artificial) for at least two months before study start, 12. Absence of sunburn, suntan, scars or other active dermal lesions on the area selected for test purposes 13. Color uniformity of the test area (without nevi, blemishes or solar lentigo and without hair) 14. Promise to not change the normal daily routine, effective contraceptive therapy 15. Ability to comply with the protocol and follow protocol’s constraints and specific requirements
Exclusion criteria
Exclusion criteria: 1. Breastfeeding, pregnancy (or unwillingness to take necessary precautions to avoid pregnancy during the study and for at least 3 months before the inclusion visit [for women of childbearing potential] 2. Staring or changing oestrogen-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study 3. Allergies or sensitivity to cosmetic products, toiletries, sunscreens, and/or topical drugs 4. Dermatological problems in the test area 5. Pharmacological treatments (both locally or systemically) 6. Positive anamnesis for atopy (allergic hypersensitivity affecting parts of the body not in direct contact with the allergen) 7. Use of self-tanning products for at least one month before study start 8. Habit to use tanning beds, 9. Medication with photosensitizing potential, drugs, and/or food supplements able to induce skin coloring, corticoids, currently or during the month before the study start 10. Participation in another clinical trial within the last two weeks prior to the inclusion visit and taking part or planning to participate to another clinical trial during the study in the same or another investigation center 11. Deprivation of freedom by administrative or legal decision or under guardianship 12. Unavailability to be contacted in case of emergency 13. Admission in a sanitary or social facility 14. Planning a hospitalization during the study 15. Impaired immune system due to immunosuppressive diseases, or use of immunosuppressive medication 16. Acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 17. History of severe reactions from exposure to sunlight (i.e., polymorphous light eruption) 18. Long-treatment or intending to have one, in particular with aspirin, products containing aspirin, corticoids, beta blockers (including eye drops), immuno-suppressive and/or desensitization drugs or under any treatment considered by the Investigator liable to interfere with the study data or incompatible with the study requirements 19. Vaccination within the 3 weeks prior to the study or intending to be vaccinated during the study 20. Any surgery, chemical or physical treatment on the experimental area within the 12 months prior to the study or foreseeing it for the duration of the study 21. Personal history of atopic dermatitis, urticaria or severe skin reaction to cosmetics, drugs or domestic products or confirmed contact dermatitis or food allergy 22. Artificial UV exposure or excessive exposure to natural sunlight or within the 2 weeks prior to the study or foreseeing UV exposures for the duration of the study (at Investigator’s judgment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UV-induced erythema reaction using instrumental measurement of skin redness at baseline and after 14, 15, 16, 17 and 56 days of product intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline and after 14 and 56 days of product intake: 1. Skin moisturization (measured by means of Cor-neometer® CM 825) 2. Skin elasticity (measured by means of Cutometer® MPA 580) 3. Transepidermal water loss (measured by means of Tewameter® TM 300) 4. Total skin antioxidant capacity (FRAP assay) 5. Skin lipoperoxides content (MDA assay) 6. Intensity of melanin staining (colorimetric method) 7. Skin radiance (colorimetric method) 8. Wrinkle depth, length, area and wrinkle count (skin profilometry by structured light 3D scanner, and clinical scoring) | — |
Countries
China, Italy
Outcome results
None listed