Visible face roughness and mild to moderate skin slackness, brittle nails and damaged/brittle hair Skin and Connective Tissue Diseases
Conditions
Interventions
The active food supplement intervention (Kera-Diet®) is a food-grade hydrolysate of natural keratin that improves hair and nail condition: brightness, volume, density, growth and vitality. It boosts k
two capsules in the morning and two capsules in the evening for 90 days.
All participants will apply for all the study length a base cream with no cosmetic claim for face care, two times a day (morni
Sponsors
BCF Life Sciences
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy female subjects 2. Aged between 35 and 65 years old (50% of participants aged between 35 and 50 years old and 50% of the participants aged between 51 and 65 years old in each study group) 3. Damaged/brittle hair (at least 20% of subjects due to discoloration in each study group) 4. Brittle nails (not related to pathological alterations to the nail plate) 5. Clinically showing visible face roughness (crow’s feet wrinkles) 6. Mild to moderate skin slackness 7. Phototype I to IV (according to Fitzpatrick classification) 8. Registered with health social security or health social insurance 9. Signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization 10. Able to understand the language used in the investigation center and the information given 11. Able to comply with the protocol and follow protocol constraints and specific requirements 12. Willing to use the same shampoo during the whole study period 13. Willing to attend the study visit and have hair dyes performed at least 3 weeks before 14. Willing to not use during the study period products other than the test product 15. Using effective contraception (oral/not oral) if women of childbearing potential and not expected to change during the trial 16. Have not had sun exposure (both natural or artificial) for at least 2 months 17. Accept not to be exposed in an intensive way to UV rays during the whole study duration 18. Willing to not use similar products that could interfere with the product to be tested
Exclusion criteria
Exclusion criteria: 1. Does not meet the inclusion criteria 2. Taking part or planning to participate in another clinical study in the same or in another investigation center 3. Deprived of freedom by administrative or legal decision or under guardianship 4. Admitted in sanitary or social facilities 5. Planning a hospitalization during the study 6. Consumption of food supplement(s) for skin/hair/nail care currently or within the past 12 weeks before the study 7. Breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (if women of childbearing potential) 8. 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. Acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator to be hazardous or incompatible with the study requirements 10. Chronic skin disease or skin-related treatment and drug intake 11. In the course of a long treatment or intending to have one considered by the Investigator liable to interfere with the study data or incompatible with the study requirements 12. Personal history of cosmetic, drug, domestic products or food supplement allergy 13. Pathological nail conditions 14. Systemic or local treatments/medications affecting nail growth 15. Radiotherapy, chemotherapy at any time 16. Skin/scalp condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 17. Systemic treatment affecting the hair growth taken for more than 4 consecutive weeks during the last 24 weeks before the inclusion visit 18. Any topical treatment applied on the scalp/skin within the last 2 weeks before the inclusion visit 19. Any following hair care within the last 2 weeks before the inclusion visit: dandruff shampoo, antifungal shampoo, dyeing, bleaching, perm 20. Any skin care-make-up/hair care product applied on the skin in the 3 hours before the visit and on the scalp between the last shampoo and the inclusion visit (e.g. gel, hairspray, wax, foam) 21. Known or suspected sensitization to one or more test formulation ingredients 22. Any condition that the principal investigator deems inappropriate for participation 23. Pharmacological treatments (topic or systemic) known to interfere with skin metabolism/physiology 24. Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated) 25. Unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Skin profilometry (Ra parameter, wrinkle depth, wrinkle length and wrinkle area) measured in the “crow’s feet” area) using Primos 3D (GFMesstechnik GmbH) at baseline (T0), 45 days (T45), T90 days (T90) 2. Deep skin moisturization measured using a MoistureMeterEpiD at baseline (T0), 45 days (T45), T90 days (T90) 3. Skin brightness measured using the spectrophotometer/colorimeter CM-700D (Konica-Minolta) at baseline (T0), 45 days (T45), T90 days (T90) 4. Skin elasticity and firmness measured using the suction/elongation method and the subsequent release of the skin inside the opening of the instrument (Cutometer®MPA 580, Courage+Khazaka, electronic GmbH) at baseline (T0), 45 days (T45), T90 days (T90) 5. Digital pictures acquired by means Visioface (Courage+Khazaka) at baseline (T0), 45 days (T45), T90 days (T90) 6. Skin thickness (epidermis) and fibres analysis (skin density and overall anisotropy score) measured using DeepLive™ (DAMAE Medical) at baseline (T0) and T90 days (T90) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Nails and hair brightness measured using the spectrophotometer/colorimeter CM-700D (Konica-Minolta) at baseline (T0), 45 days (T45), T90 days (T90) 2. Clinical evaluation of nail hardness/brightness using VAS score scales at baseline (T0), 45 days (T45), T90 days (T90) 3. Product acceptability and volunteers’ perceived efficacy assessed with a self-assessment questionnaire at T90 | — |
Countries
Italy
Outcome results
None listed