Effectiveness of a food supplement on skin, hair and nail conditio
- Conditions
- Visible face roughness and mild to moderate skin slackness, brittle nails and damaged/brittle hairSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN10686369
- Lead Sponsor
- BCF Life Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 132
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>2. Deep skin moisturization measured using a MoistureMeterEpiD at baseline (T0), 45 days (T45), T90 days (T90)<br>3. Skin brightness measured using the spectrophotometer/colorimeter CM-700D (Konica-Minolta) at baseline (T0), 45 days (T45), T90 days (T90)<br>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) <br>5. Digital pictures acquired by means Visioface (Courage+Khazaka) at baseline (T0), 45 days (T45), T90 days (T90)<br>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 Outcome Measures
Name Time Method 1. Nails and hair brightness measured using the spectrophotometer/colorimeter CM-700D (Konica-Minolta) at baseline (T0), 45 days (T45), T90 days (T90)<br>2. Clinical evaluation of nail hardness/brightness using VAS score scales at baseline (T0), 45 days (T45), T90 days (T90)<br>3. Product acceptability and volunteers’ perceived efficacy assessed with a self-assessment questionnaire at T90