To evaluate and compare the in vivo safety and efficacy of two hair care formulations in terms of reduction in dandruff effect on healthy human subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
研究概览
简要总结
OBJECTIVE :The objective of this study will be to evaluate & compare the in-vivo safety and efficacy of two hair care formulations in terms of reduction in dandruff effect on healthy human subjects The evaluation will be performed using:Subject’s Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Corneometry, Photographs of scalp build-up by Dino-lite
POPULATION :72 (36 Males and 36 Females) subjectswill be selected for the study.The subjects selected for this study are healthy males & females, aged between 18 and 35 years old having moderate to severe dandruff (at least shoulder length hair for Females)
STUDY DURATION : 70 days including the 14 days conditioning period, 28 days application period and 28 days Reoccurrence period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian Asian male & females subjects.
- •Healthy subjects.
- •Skin is healthy on the studied anatomic unit 4)Having moderate to severe dandruff.
排除标准
- •For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2)Having refused to give his/her assent by not signing the consent form 3)Taking part in another study liable to interfere with this study 4)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 5)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)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) 11)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months 12)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 13)Having applied a hair care product on studied area the first day of the study (hair should be washed with the provided neutral shampoo two days prior to the day of visit.) 14)Having applied a hair care product on study visits (hair should be washed with the provided test product two days prior to the day of study visits.).
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.