An Exploratory Approach for Validation and Standardization of Test Methods and Evaluators to Conduct In-Vivo Clinical Safety and Efficacy Testing of Hair Care Range of Products.
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
- The objective of this validation study is to evaluate the standardize the methods, procedural steps, validate the hair growth rate measurement, 60-s combing test, pull test, pluck test, subjective scoring of Hair quality appearance and scalp condition - evaluations techniques that are used during the conduct of clinical safety and efficacy studies for hair care product evaluation at/by NovoBliss Research on healthy adult human subjects
研究概览
简要总结
This is an In-house process validationstudy.
Thisvalidation study will be carried out on/by study staff of the NovoBlissResearch who is voluntarily wish to take part in this internal validationstudy. There are multiple hair evaluation techniques involved for testing hairgrowth products these testing methods for establishing documentary evidencedemonstrate that standardised procedural steps, processes and methods carriedout in testing for hair care safety and efficacy studies to maintain thedesired level of compliance.
It is veryimportant that in addition to final testing and compliance of products duringan actual clinical study, it is also assured that the processes willconsistently produce consistent results. The consistent results are establishedin terms of specifications for the outcome of the process.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18-75 years (both inclusive) at the time of consent.
- •Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- •Females of childbearing potential must have a self-reported negative urine pregnancy.
- •Subject is in good general health as determined by the Investigator on the basis of medical history.
- •Subject is willing and able to follow and allow study staff to perform study test methods.
- •Subject is willing and able to follow the study directions, participate in the study, returning for all specified visits.
- •Subject must be able to understand and provide written informed consent to participate in the study.
排除标准
- •Subject have history of allergy to any ink.
- •Subject have participated any clinical research study related to hair care products.
- •Subject having history of diabetes 4) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
- •Subject having known history of any skin diseases including eczema, atopic dermatitis or active cancer.
结局指标
主要结局
The objective of this validation study is to evaluate the standardize the methods, procedural steps, validate the hair growth rate measurement, 60-s combing test, pull test, pluck test, subjective scoring of Hair quality appearance and scalp condition - evaluations techniques that are used during the conduct of clinical safety and efficacy studies for hair care product evaluation at/by NovoBliss Research on healthy adult human subjects
时间窗: Day 01 and Day 04
次要结局
- Not Applicable