Seasonal hair loss, brittle nails, and dry, poorly elastic facial skin Skin and Connective Tissue Diseases
Conditions
Interventions
The study is designed as a randomized, double-blind, placebo-controlled clinical trial. A total of 66 healthy male and female volunteers aged 18–65 years are enrolled and randomized in parallel groups
Sponsors
Nutris We Care About You
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy female and male subjects (without any specific repartition). 2. Caucasian ethnicity. 3. Aged between 18 and 65 years (extremes included). 4. Subjects with seasonal hair loss. 5. Subjects with brittle nails. 6. Subjects with dry and poorly elastic facial skin. 7. Subjects with minimum hair length of 6/7 cm. 8. Uncoloured hair and willingness not to dye or bleach hair during the study. 9. Willingness not to cut hair during the study. 10. Subjects registered with National Health Service (NHS). 11. Subjects certifying the truthfulness of the personal data disclosed to the investigator. 12. Subjects able to understand the language used in the investigation center and the information given by the investigator. 13. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements. 14. Subjects committed not to change the daily routine or the lifestyle. 15. Subjects under 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. 16. 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 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. 3. Subjects participating or planning to participate in other clinical trials. 4. Subjects who participated in a similar study without respecting an adequate washout period (at least 1 month). 5. Subjects that have food intolerances or food allergies or allergies to ingredients of the study product. 6. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator. 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 1 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. Subjects with alimentary/eating disorders (i.e. bulimia, psychogenic eating disorders, etc.). 14. Subjects breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of hairs lost measured using Pull Test and Wash Test at baseline (T0), day 56 (T56), and day 84 (T84). 2. Hair elasticity (% elongation) measured using Tensolab 2512A dynamometer according to UNI EN ISO 5079:1998 at T0, T56, and T84. 3. Hair density (hairs/cm²) measured using phototrichogram analysis with TrichoScan® at T0 and T84. 4. Hair growth (cm) measured using hair length measurement in the target area at T84. 5. Hair brightness measured using clinical scoring scale by dermatologist assessment at T0, T56, and T84. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Skin moisturization measured using Corneometer® at T0, T56, and T84. 2. Skin elasticity (R2) measured using Cutometer® MPA 580 at T0, T56, and T84. 3. Skin firmness (R0) measured using Cutometer® MPA 580 at T0, T56, and T84. 4. Skin brightness measured using clinical scoring scale by dermatologist assessment at T0, T56, and T84. 5. Nail hardness measured using clinical scoring scale by dermatologist assessment at baseline (T0), day 56 (T56), and day 84 (T84). 6. Subject self-assessment of product efficacy and tolerability measured using 10-item self-assessment questionnaire at T84. 7. Incidence of adverse events (AEs) and serious adverse events (SAEs) measured using standard adverse event reporting forms throughout the 84-day study period. | — |
Countries
Italy
Contacts
Public ContactVeronica Gallo
Outcome results
None listed