Androgenetic alopecia, fine lines/wrinkles and loss of skin elasticity. Skin and Connective Tissue Diseases
Conditions
Interventions
The active intervention (NOVASTYNE® Glow) is a proprietary peptido amino mineral complex, while the placebo intervention is maltodextrin. Both the active and the placebo products are used as follows:
Sponsors
NOVACTIVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Good general health 2. Caucasian ethnicity 3. Female and male sex 4. Age between 33 and 67 (extremes included) years old 5. Subject showing an andro-genetic hair loss; for women I-II degrees on Ludwig scale and for men II/III vertex degrees on Hamilton-Norwood modified scale 6. Subjects showing fine lines/wrinkles and loss of skin elasticity 7. Subjects having a positive pull test result 8. Subjects with minimum hair length of 6/7 cm 9. Subjects who stopped any anti hair loss treatment at least 3 months prior the study 10. Subjects agreeing not to take any treatment (oral or topic) able to interfere with the hair growth, diameter or fall during the whole study duration 11. Willingness not to dye/blench hair (at roots) during all the study period 12. Willingness not to cut hair for all the study length 13. Subjects registered with health social security or health social insurance 14. Subjects having signed their written Informed Consent form (ICF) and Privacy Policy for their participation in the study and a photograph authorization 15. Subjects able to understand the language used in the investigation centre and the information given 16. Subjects able to comply with the protocol and follow protocol constraints and specific requirements 17. Willingness to take during all the study period only the product to be tested 18. Willingness not to use/take similar products/food supplement that could interfere with the product to be tested 19. Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet etc.) 20. Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial (for women).
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Subject is taking part or planning to participate to another clinical study in the same or in another investigation centre 3. Subject who is deprived of freedom by administrative or legal decision or under guardianship 4. Subject admitted in a sanitary or social facilities 5. Subject who is planning a hospitalization during the study 6. Subject has participated in another clinical study with anti-hair loss product or treatment within the last 24 weeks before the inclusion visit 7. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (if women of childbearing potential) 8. Subject has started or changed oestrogen-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study 9. Subjects with any acute, chronic, or progressive disease or skin condition (e.g. sever atopic dermatitis, psoriasis) that may interfere with the study data or that the investigator considers dangerous to the subject or incompatible with the requirements of the study 10. Subjects under radiotherapy, chemotherapy at any time 11. Subjects under any locally pharmacological/non-pharmacological treatment applied on the area of interest monitored during the test 12. Subject having food disorders (i.e. bulimia, psychogenic eating disorders, etc.) 13. Subject who has any other hair disorder or hair disease (e.g. any other type of alopecia…) 14. Subject having excessive and/or fluctuating hair shedding for more than 6 months 15. History or clinical signs of hyperandrogenaemia 16. Systemic treatment affecting the hair growth taken for more than 4 consecutive weeks during the last 24 weeks before inclusion visit 17. Systemic or local androgenetic alopecia treatment or product, taken or applied (Minoxidil, Aminexil, Finasteride, Dutasteride, cosmetic solution or capsules with vitamin B, zinc, caffeine…) for more than 4 consecutive weeks during the last 24 weeks before the inclusion visit 18. Any hair care product applied on the scalp between the last shampoo and the inclusion visit (e.g. gel, hairspray, wax, foam…) 19. Scalp surgery (hair transplants, laser) at any time. 20. Subjects that have food intolerances or food allergies or allergies to ingredients of the study product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phototricogram (TrichoScan®): hair density (number of total hairs per cm²), density of telogen hair (number of hairs in telogen phase per cm²) and proportion (%), density of anagen hair (number of hairs in anagen phase per cm²) and proportion (%), number of hairs protected against falling out (HPF), Hair growth (cm), Hair brightness (gloss parameter, a.u.) and Pull test (number of hair) at T0, T28, T56 and T84 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin moisturization (a.u.), Skin elasticity (R2) (Ua/Uf), Skin firmness (R0) (Uf; mm), Skin wrinkledness in the crow’s feet area (Sv parameter - µm), Skin smoothness in the crow's-feet area (Sa parameter - µm), Total wrinkle area (mm²) and Total wrinkle length (mm) at T0, T28 and T56 days. At each checkpoint, the tolerability of the treatment is followed by the study principal investigator, and subjects are asked to score product performance on a self-assessment questionnaire. | — |
Countries
Italy
Contacts
Public ContactEleonora Spartà
Outcome results
None listed