Evaluation of in vivo safety and efficacy of hair care formulation in terms of hair growth effect.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Hair growth i.e., improvement in A:T ratio & safety
研究概览
简要总结
Primary Objective:
The objective of this study will be to evaluate in vivo safety and efficacy of hair care formulation in terms
of hair growth i.e., improvement in A:T ratio on healthy human subjects for product coded:
Secondary Objective:
The objective of this study is to evaluate the efficacy of Skin care formulation in terms of improvement
in hair thickness, reduction in hair fall on healthy human subjects.
Population: 36 (18 male and 18 female) subjects are selected for the study
The subjects selected for this study are
healthy males & females aged between 30 and 50 years & showing initial stage of baldness, For
Males: Hamilton Scale Class II to III (including III, IIIA and III vertex) ; for Females: Ludwig
Study timepoints: Screening, Baseline, T+14 Days, T+26 Days, T+28 Days, T+42 Days, T+54 Days, T+56
Days, T+70 Days, T+82 Days, T+84 Days
The evaluation is performed using: Subject’s self-assessment questionnaire, Dermatological evaluation: Cosmetic Acceptability, Phototrichogram analysis, Analysis of hair thickness through Dino-lite Digital Microscope, Counting of Fallen Hair after Standardized Combing
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
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 months 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 months) 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.
结局指标
主要结局
Hair growth i.e., improvement in A:T ratio & safety
时间窗: Screening, Baseline,T+14 Days, T+26 Days,T+28 Days,T+42 Days, T+54 Days,T+56 Days,T+70 Days,T+82 Days,T+84 Days
次要结局
- Improvement(in hair thickness, reduction in hair fall)
研究者
Dr Raji Patil
MASCOT-SPINCONTROL India Pvt. Ltd.