Androgenetic alopecia Skin and Connective Tissue Diseases Androgenic alopecia
Conditions
Interventions
The active intervention (Actrisave™) is a blend of Oryza sativa (L.) and Opuntia cus indica (L.) extracts
an additional visit is foreseen after 1 month from the last product intake. At each visit, partcipants are asked to come to the study facilities on two not consecutive days. During the screening visit
Sponsors
BIONAP srl
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects 2. Subjects aged between 18 and 55 years old inclusive 3. Subjects with all types of scalp and hair 4. Subjects registered with health social security or health social insurance 5. Subjects having signed their written Informed Consent Form (ICF) for their participation in the study and a photograph authorization 6. Subjects certifying the truth of the personal information declared to the Investigator 7. Subjects able to understand the language used in the investigation center and the information given 8. Subjects able to comply with the protocol and follow protocol’s constraints and specific requirements 9. Subjects considered a “healthy subject” by the Investigator 10. If the subject is under systemic pharmacological treatment, this should be stable for at least 1 month before the study start and do not change over the study period, excluding the treatments specified in the exclusion criteria 11. Mild to moderate (from II to III vertex on Hamilton-Norwood scale) androgenetic alopecia 12. Subjects agreeing to preserve a length of hair longer than 5 cm during the study 13. Subjects agreeing to have a zone of about 2 cm² shaved on the scalp 14. Willingness to use the same shampoo during all the study period
Exclusion criteria
Exclusion criteria: 1. Subjects taking part or planning to participate in another clinical trial during the study in the same or another investigation centre 2. Subjects belonging to the staff of the investigation centre 3. Subject who has participated in another clinical trial with anti-hair loss product or treatment within the last 24 weeks before the inclusion visit 4. Subjects with an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 5. Subjects 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 6. Subjects with a skin condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 7. Subjects with a personal history of cosmetic, drug or domestic products irritative reactions 8. Inflammatory skin disease or progressive skin lesion on the scalp (psoriasis, seborrheic dermatitis, severe erythema, severe excoriation, severe sunburn, etc) 9. Subjects having a scalp lesion in relief which may be traumatized 10. History of hypersensitivity or intolerance to any of the ingredients in the product formula 11. Systemic treatment affecting the hair growth taken for more than 4 consecutive weeks during the last 24 weeks before inclusion visit: retinoids, anti-mitotic, cytotoxic drugs other than antineoplastic, anti-androgens (spironolactone, flutamide), androgens, anti-epileptic agents, interferon-alpha 12. 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 13. Any other local treatment applied on the scalp (non-steroidal anti-inflammatory, ketoconazole) within the last 2 weeks before the inclusion visit 14. Any hair care product applied on the scalp between the last shampoo and the inclusion visit (e.g., gel, hairspray, wax, foam) 15. Radiotherapy, chemotherapy at any time 16. Scalp surgery (hair transplants, laser) at any time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hair loss related parameters (anagen, telogen, and the total hair number) measured using TrichoScan at baseline, and after 3, 6, and 7 months product use | — |
Secondary
| Measure | Time frame |
|---|---|
| Hair growth measured using a clinical score scale by the dermatologist at baseline, and after 3, 6, and 7 months product use. At each checkpoint subjects are also asked to score performance on a self-assessment questionnaire. | — |
Countries
Italy
Outcome results
None listed