ISRCTN17383899进行中（未招募）未知
Double-blind, randomized, placebo-controlled assessment of the effect of a food supplement (Actrisave™) on hair trophism and normal growth in subjects with androgenetic alopecia
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- BIONAP srl
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •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
排除标准
- •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
研究者
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