CTRI/2024/04/065569尚未招募Unknown
Evaluation of in vivo safety and efficacy of hair care formulation in terms of hair growth effect. - NI
KAYA LIMITED0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
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
入选标准
- •Indian / Asian male & female subjects.
- •Healthy subjects (no infectious and evolutive pathology which could make the subject
- •vulnerable and stop the study, no pathology which could interfere with the study, no symptom
- •in the process of an exploratory checkup)
- •Between 30 and 50 years of age.
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
- •Having androgenetic alopecia of class I-2 to I-4 according to Ludwig Scale for females and
- •class II to III (including III, IIIA and IIIvertex) according to Norwood Hamilton Scale for males.
排除标准
- •For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three
- •Having refused to give his/her assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
- •Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less
- •than 6 months)
- •Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •Being epileptic
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6
- •Having cutaneous hypersensitivity
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products
- •Following a chronic or intermittent medicinal treatment comprising any of the following
- •products: aspirin-based products, anti-inflammatories, antihistamines, anti-coagulants,
- •corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months
- •Having changed his/ her cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit
- •Having applied a cosmetic product on the studied areas the first day of the study.
- •Refusing to follow the restrictions below during the study:
- •- For female, do not take part in any family planning activities leading to pregnancy and
- •breastfeeding.
- •- Do not take part in another study liable to interfere with this study
- •- Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •- Do not change his cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit.
- •- During the study: Do not use other hair care products than the tested products to the studied areas (Only provided test product is allowed).
- •- The day of the measurements: Hair must be washed with provided neutral shampoo. No other hair care product must be used.
- •Having naturally fair or white hair
- •Having a dermatosis on the scalp
- •Having history of any hormonal problem.
- •Having surgery history on the scalp (micro transplants …)
- •Refusing the shaving of an area of the scalp of about 1.5 cm², the first day of the study and several times during the study
- •Having presented a factor inducing a telogen effluvium in the 3 months preceding the start of the study (important stress, high fever…)
- •Presenting an acute or chronic general disease or pathology which could have an influence on hair endocrinopathy (diabetes, thyroid…), high blood pressure, renal problems, hepatic problems, known anemia.
- •Having contact allergy or atopic predisposition.
- •Having history of medical/surgical events that may significantly affect the study outcome e.g.,h/o typhoid or jaundice etc.
研究者
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