NCT05954039已完成不适用
Double-blind, Randomized, Placebo-controlled Clinical-instrumental Evaluation of the Efficacy of a Dietary Supplement Claiming Anti-hair Loss Properties and Hair Aspect Improvement
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Seppic
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Telogen hair proportion
研究概览
简要总结
The study is aimed to assess the efficacy of a dietary supplement composed of a Wheat Polar Lipid Complex (WPLC) in reducing hair loss and improving hair aspect.
详细描述
A double blind, parallel groups, placebo-controlled study is carried out on 60 healthy female subjects aged between 18 and 65 years old with all hair type showing diffuse and temporary hair shedding with a proportion of hair in telogen phase >15%.
The study foresees 84 days of products intake. Evaluations of the parameters under study are performed at baseline, after 56 and 84 days of products consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects,
- •Caucasian ethnicity,
- •Age between 18 and 65 years old,
- •All hair type included,
- •Women showing a proportion of hair in telogen phase > 15%,
- •Subjects complaining brittle and thin hair,
- •Subjects who stopped any anti hair loss treatment at least 3 months prior the study,
- •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,
- •Subjects who have not been involved in any other similar in the last 3 months,
- •Subjects registered with health social security or health social insurance,
- •Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial,
- •Subjects able to understand the language used in the investigation center and the information given,
- •Subjects able to comply with the protocol and follow protocol's constraints and specific requirements,
- •Willingness to use the same products for hair care during all the study period,
- •Willingness not to cut hair for all the study length,
- •Subjects having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization.
排除标准
- •Subject does not meet the inclusion criteria,
- •Subject is taking part or planning to participate to another clinical study in the same or in another investigation centre,
- •Subject is deprived of freedom by administrative or legal decision or under guardianship,
- •Subject is admitted in a sanitary or social facilities,
- •Subject is planning an hospitalization during the study,
- •Subject has participated in another clinical study with anti-hair loss product or treatment within the last 24 weeks before the inclusion visit,
- •Subject is breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential),
- •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,
- •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,
- •Subject is in 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,
- •Subject having a 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,
- •Subject having personal history of cosmetic, drug, domestic products or food supplements allergy,
- •Subject having food disorders,
- •Subject who has any other hair disorder or hair disease (female pattern hair loss, any type of alopecia...),
- •Subject having excessive and/or fluctuating hair shedding for more than 6 months,
- •History or clinical signs of hyperandrogenemia (menstrual cycle >35 days and hirsutism and acne),
- •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,
- •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,
- •Any other topical treatment applied on the scalp (non-steroidal anti-inflammatory, ketoconazole...) within the last 2 weeks before the inclusion visit,
- •No hair wash in the 48 hours before each visit,
- •Any following hair care within the last 2 weeks before each visit: dandruff shampoo, antifungal shampoo, dyeing, bleaching, perm,
- •Any hair care product applied on the scalp between the last shampoo and the inclusion visit (e.g. gel, hairspray, wax, foam...),
- •Radiotherapy, chemotherapy at any time,
- •Scalp surgery (hair transplants, laser) at any time
结局指标
主要结局
Telogen hair proportion
时间窗: 84 days
Phototrichogram
次要结局
- Scalp sebum content(84 days)
- Hair diameter(84 days)
- Hair volume(84 days)
- Hair loss(84 days)
- Hair growth(84 days)
- Hair elasticity(84 days)
- Hair density(84 days)
- Anagen hair proportion(84 days)
- Self-assessment of product efficacy(84 days)
研究者
研究点 (2)
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