A clinical study to evaluate the efficacy and safety of hair care formulation in terms of reduction in hair fall and improvement in hair growth.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction in number of fallen hair
研究概览
简要总结
OBJECTIVE: To assess the efficacy & safety of hair care formulation, reduction in hair fall and improvement in hair growth (hair length) in female & male subjects with mild to moderate hair fall.
Primary Endpoint: Percentage reduction in number of fallen hair as assessed through counting of fallen hair after standardized combing at day 28 compared to baseline
Secondary Endpoints: Percentage reduction in number of fallen hair as assessed through counting of fallen hair after standardized combing at day 14 compared to baseline
1)Percent improvement in hair length as assessed by bleaching technique at days 14 & 28 compared to baseline
2) Safety findings (on clinical examination) by the dermatologist at baseline and days 14 & 28
3) Percent panel agreement* based on subject self-evaluation (SSE) questionnaire score for efficacy at days 14 & 28 for Reduction in hair fall and Improvement in hair growth
STUDY DESIGN: This is a comparative (For hair growth, results obtained in treatment phase will be compared with that of natural growth in conditioning phase), prospective, interventional study.
STUDY POPULATION: 36 (18 Male +18 Female) subjects. The subjects selected for this study are male & female subjects of 18-45 years of age having mild to moderate hair fall.
STUDY DURATION: Screening period 1 day, Pretreatment period 28 days, Treatment period 28 days
The evaluation is performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Counting of fallen hair after standardized combing, Measurement of hair growth by bleaching technique
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Asian Indian male and 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) 3)Between 18 and 45 years of age.
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 5)Specific criteria: Having mild to moderate hair fall.
排除标准
- •For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past six months.
- •Having refused to give her assent by not signing the consent form.
- •Taking part in another study is 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) 6)Having a progressive asthma (either under treatment or last fit in the last 2 years) 7)Being epileptic 8)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9)Having cutaneous hypersensitivity 10)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products 11)Following a chronic or intermittent medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 12)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months 13)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 hair care product and cosmetic product on the studied area as well as on the face the first day of the study (except the neutral shampoo without anti-dandruff and anti hairfall claim) 15)Refusing to follow the below restrictions during the study: For females: 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, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) Do not change his/her 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 (except the neutral shampoo without anti-dandruff and anti hairfall claim.) The day of the measurements: No hair care must be used including test product.
- •Having untangled their hair at home, before coming to the site for observations, the first day of the study.
- •Specific criteria Having naturally fair or white hair (Which will interfere the evaluation) Having a dermatosis on the scalp Having surgery history on the scalp (micro transplants …) Refusing the bleaching of two areas of the scalp of approx.
- •40 hairs, the first day of the study.
- •Refusing the plucking of approx.
- •10 hairs, during the entire study Having presented a factor inducing a telogen effluvium in the 3 months preceding the start of the study (delivery, important stress, high fever…) In the previous 6 months Having undergone the Minoxidil treatments Antiandrogen medicine (cyproterone acetate, spironolactone, flutamide) Having undergone one of the following treatments known to induce hair loss: retinoids, anti-coagulants, anti-convulsive drugs, chemotherapy, beta-blocking agents, non steroidal anti-inflammatory drugs, corticoids … Having modified her hormonal contraception In the previous 3 months Having undergone a local or general anti hair loss treatment (Biotin, dexpanthenol, sulphur amino-acid, B6 vitamin, zinc) Having taken a food supplement with an anti hair loss claim Having taken an iron based treatment.
- •Do not start a medicinal treatment which could influence the cycle of the hair (anti-hair loss treatment or treatment inducing hair loss) Do not use local anti-hair loss treatment nor anti-hair loss cosmetic products.
- •Do not keep hair length less than 5 cm.
- •Do not use shampoo or hair care or treatment with an anti-dandruff or anti-hairfall claim.
- •Do not have hair coloured, lightened or permed at the hairdresser or at home.
- •Do not use products such as: hair-spray, hair gel, straightening products Do not perform a traumatic hairstyle which could damage hair.
- •Do not perform too hot brushing or with a too important frequency.
- •The day of measurement: Untangle the hair (slightly) at home, before coming to the site for observation.
结局指标
主要结局
Reduction in number of fallen hair
时间窗: Baseline, Day 28
次要结局
- Reduction in the number of fallen hairs, Improvement in hair length, Safety evaluation based on dermatologist assessment, Percentage of subjects reporting improvement in: Reduction of hair fall, Improvement in hair growth, Subject Self-Evaluation questionnaire scores for Safety & Cosmetic appeal.(Baseline, Day 14, Day 28)
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.