Clinical evaluation of the cutaneous tolerance and efficacy of single or two treatment application of herb based anti-lice product(s)under dermatological control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of anti-lice efficacy of investigational products in comparision to a already marketed product by count of lice and nymphs before and after product application
研究概览
简要总结
The objective of this study are:
Primary objective(s)
The primary objective of the study is to assess the anti-lice efficacy of a shampoo alone and drops in
combination with shampoo, in a single- or two-treatment application with comparison to a marketed
formulation.
Secondary objective(s)
The secondary objectives of this study are as follows:
• Assessment of cutaneous safety and tolerance by the Principal Investigator through AE/LI
monitoring
•Appreciation of the efficacy, tolerance and organoleptic characteristics of the product through
subjective evaluation questionnaire
• Photo documentation of the eggs (collected from hair strands) and analysis of the ovicidal activity
of the test products, will be done as an exploratory objective by Dabur Research Foundation
Sample Size: 40 male and female subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Healthy Indian male and female subjects 2 Age from 3 to15 years (both inclusive) 3 Subjects presenting with lice infestation of scalp and having at least five live lice and five eggs 4 Subjects with short , medium or long length hair 5 Subjects with straight or wavy or curly hair.
- •6 Subject willing and capable to follow the study rules and a fixed schedule 7 Subject/ Subject’s LAR able to give written informed consent and to comply with the requirements of the study.
排除标准
- •1 Subjects not matching one of the above mentioned inclusion criteria 2 Subject having any acute skin irritation or diseases on the application site 3 Known hypersensitivity to any of the study products or constituents (positive reaction in Epicutaneous sensitivity testing) 4 Any significant medical condition or drug history that would interfere with the study assessments 5 Subjects with dermatological disorders which could interfere with the evaluation of the product tested 6 Subjects with intellectual/ mental inability to follow study instructions (if suspected) or incapacitation 7 Participation in any other clinical trial up to 1 month prior to inclusion and during the study.
结局指标
主要结局
Evaluation of anti-lice efficacy of investigational products in comparision to a already marketed product by count of lice and nymphs before and after product application
时间窗: T0 (before product application) & | T30 (approximately 30 minutes after initiation of product application) at Day 0 and Day 10, and at | a single time point on Day 5 and Day 14
次要结局
- 1.The number of reported AE/ LI throughout the study will be used to assess the cutaneous safety and tolerance by the investigator(2. Perception of efficacy, tolerance and organoleptic characteristics of the product through responses)