ISRCTN10686369已完成Unknown
Comparative assessment of the efficacy of a food supplement on skin, hair and nail condition: a randomized placebo/benchmark controlled study
BCF Life Sciences0 个研究点目标入组 132 人开始时间: 2023年8月25日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 132
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
- Female
入选标准
- •1. Healthy female subjects
- •2. Aged between 35 and 65 years old (50% of participants aged between 35 and 50 years old and 50% of the participants aged between 51 and 65 years old in each study group)
- •3. Damaged/brittle hair (at least 20% of subjects due to discoloration in each study group)
- •4. Brittle nails (not related to pathological alterations to the nail plate)
- •5. Clinically showing visible face roughness (crow’s feet wrinkles)
- •6. Mild to moderate skin slackness
- •7. Phototype I to IV (according to Fitzpatrick classification)
- •8. Registered with health social security or health social insurance
- •9. Signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
- •10. Able to understand the language used in the investigation center and the information given
- •11. Able to comply with the protocol and follow protocol constraints and specific requirements
- •12. Willing to use the same shampoo during the whole study period
- •13. Willing to attend the study visit and have hair dyes performed at least 3 weeks before
- •14. Willing to not use during the study period products other than the test product
- •15. Using effective contraception (oral/not oral) if women of childbearing potential and not expected to change during the trial
- •16. Have not had sun exposure (both natural or artificial) for at least 2 months
- •17. Accept not to be exposed in an intensive way to UV rays during the whole study duration
- •18. Willing to not use similar products that could interfere with the product to be tested
排除标准
- •1. Does not meet the inclusion criteria
- •2. Taking part or planning to participate in another clinical study in the same or in another investigation center
- •3. Deprived of freedom by administrative or legal decision or under guardianship
- •4. Admitted in sanitary or social facilities
- •5. Planning a hospitalization during the study
- •6. Consumption of food supplement(s) for skin/hair/nail care currently or within the past 12 weeks before the study
- •7. Breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (if women of childbearing potential)
- •8. Has started or changed estrogen-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study
- •9. Acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator to be hazardous or incompatible with the study requirements
- •10. Chronic skin disease or skin-related treatment and drug intake
- •11. 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
- •12. Personal history of cosmetic, drug, domestic products or food supplement allergy
- •13. Pathological nail conditions
- •14. Systemic or local treatments/medications affecting nail growth
- •15. Radiotherapy, chemotherapy at any time
- •16. Skin/scalp condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •17. Systemic treatment affecting the hair growth taken for more than 4 consecutive weeks during the last 24 weeks before the inclusion visit
- •18. Any topical treatment applied on the scalp/skin within the last 2 weeks before the inclusion visit
- •19. Any following hair care within the last 2 weeks before the inclusion visit: dandruff shampoo, antifungal shampoo, dyeing, bleaching, perm
- •20. Any skin care-make-up/hair care product applied on the skin in the 3 hours before the visit and on the scalp between the last shampoo and the inclusion visit (e.g. gel, hairspray, wax, foam)
- •21. Known or suspected sensitization to one or more test formulation ingredients
- •22. Any condition that the principal investigator deems inappropriate for participation
- •23. Pharmacological treatments (topic or systemic) known to interfere with skin metabolism/physiology
- •24. Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated)
- •25. Unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function
研究者
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