ISRCTN12522754进行中（未招募）Unknown
Multi-ethnic clinical-instrumental evaluation of the efficacy of two doses of a dietary supplement claiming anti-hair loss properties. A randomized, placebo-controlled study
ROELMI HPC Srl0 个研究点目标入组 60 人开始时间: 2024年3月1日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- All
入选标准
- •1. Healthy female (50%) and male (50%) subjects
- •2. Multi-ethnic panel (50% Asian and 50% Caucasian ethnicity)
- •3. Aged between 18 and 65 (extremes included) years old
- •4. All hair types included
- •5. Subjects showing acute telogen effluvium from less than 6 months (due to fatigue/stress/deficient diet/post-partum/hormonal/fever, etc)
- •6. Subjects presenting > 15% of telogen parameter at inclusion
- •7. Subjects with a hair length of at least 5 cm
- •8. Subjects complaining of brittle and thin hair
- •9. Subjects who stopped any anti hair loss treatment at least 3 months prior to 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. Subjects registered with health social security or health social insurance
- •12. Subjects able to understand the language used in the investigation center and the information given
- •13. Subjects able to comply with the protocol and follow the protocol’s constraints and specific requirements
- •14. Willingness to use the same products for hair care during all the study period
- •15. Willingness not to cut hair for all the study length
- •16. Willingness not to dye hair during the 4 weeks preceding the T0 visit and during the 4 weeks preceding the T84 visit
- •17. Subject is aware of the study procedures and has signed an informed consent form, a photograph authorization and privacy information form
排除标准
- •1. Subject does not meet the inclusion criteria
- •2. Subject is taking part or planning to participate in another clinical study in the same or in another investigation centre
- •3. Subject is deprived of freedom by administrative or legal decision or under guardianship
- •4. Subject is admitted to a sanitary or social facilities
- •5. Subject 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 3 months before the inclusion visit
- •7. Subject is breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the 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. Subject having 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
- •10. Subject is in the course of a treatment or intending to have one considered by the Investigator liable to interfere with the study data or incompatible with the study requirements
- •11. Subject having a skin/scalp condition (psoriasis, seborrheic dermatitis, severe erythema, severe excoriation, severe sunburn, etc), liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •12. Subject having a personal history of cosmetic, drug, domestic products or food supplements allergy
- •13. Subject having food disorders
- •14. Subject who has any other hair disorder or hair disease (female pattern hair loss, any type of alopecia)
- •15. Subject having excessive and/or fluctuating hair shedding for more than 6 months
- •16. History or clinical signs of hyperandrogenemia (menstrual cycle >35 days and hirsutism and acne)
- •17. 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
- •18. 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
- •19. Any other topical treatment applied on the scalp (non-steroidal anti-inflammatory, ketoconazole…) within the last 2 weeks before the inclusion visit
- •20. Any following hair care within the last 2 weeks before the inclusion visit: dandruff shampoo, antifungal shampoo, dyeing, bleaching, perm,
- •21. Any hair care product applied on the scalp between the last shampoo and the inclusion visit (e.g. gel, hairspray, wax, foam…),
- •22. Radiotherapy, chemotherapy at any time
- •23. Use of any other product (s) similar to the one in the study
- •24. Scalp surgery (hair transplants, laser) at any time
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