Healthy volunteers with androgenetic alopecia Skin and Connective Tissue Diseases
Conditions
Interventions
The active intervention is a blend of Oryza sativa (L.) and Opuntia cus indica (L.) extracts (Actrisave™), while the placebo intervention contains the same excipients without the active extract.
A res
Sponsors
BIONAP S.r.l.
Eligibility
Sex/Gender
Female
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Healthy female subjects 2. Subjects of Caucasian ethnicity 3. Subjects aged between 18 and 64 years (extremes included) 4. Subjects with mild to moderate androgenetic alopecia * 5. Subjects with hair that is at least 5 cm long 6. Subjects with dull and mild to moderately damaged hair 7. Subjects registered with national health service 8. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel 9. Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel 10. Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements 11. Subjects who commit not to change their daily routine or lifestyle during the study ** 12. Subjects on 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 13. Subjects informed about the test procedures who have signed a consent form and privacy agreement * From I to II on Ludwig scale ** Subjects are asked not to change their usual hair hygiene and styling products (such as shampoo, conditioner, hair gel, hairspray, etc.) throughout the study
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal 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 one month) 5. Subjects that have food intolerances or food allergies to ingredients of the study product 6. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator **** 7. Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one 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 who have or have had a history of alcohol or drug addiction 13. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc) 14. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential). *** Including oncological diseases, diabetes, autoimmune diseases, acute inflammatory diseases, ongoing infectious diseases, and alopecia areata. **** Including corticosteroid drugs, biological drugs, and cytostatic drugs.
Countries
Italy
Contacts
Public ContactRoberta Villa
Outcome results
None listed