Efficacy of a food supplement in protecting the skin from sun and aging

Not Applicable

Completed

• Conditions: Mild-to-moderate skin aging; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN89244753
• Lead Sponsor: BIONAP srl

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35684041/ (added 13/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-21
• Study Start: 2022-05-10
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
V-induced erythema reaction using instrumental measurement of skin redness at baseline and after 14, 15, 16, 17 and 56 days of product intake

Secondary Outcome Measures

Name	Time	Method
Measured at baseline and after 14 and 56 days of product intake:<br>1. Skin moisturization (measured by means of Cor-neometer® CM 825)<br>2. Skin elasticity (measured by means of Cutometer® MPA 580)<br>3. Transepidermal water loss (measured by means of Tewameter® TM 300)<br>4. Total skin antioxidant capacity (FRAP assay)<br>5. Skin lipoperoxides content (MDA assay)<br>6. Intensity of melanin staining (colorimetric method)<br>7. Skin radiance (colorimetric method)<br>8. Wrinkle depth, length, area and wrinkle count (skin profilometry by structured light 3D scanner, and clinical scoring)