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
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluate the standardize the methods, procedural steps
研究概览
简要总结
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.
A total of 40 subjects will be enrolled.
详细描述
This is an internal standardization and validation study. This standardization and validation study will be carried out by the trainee evaluators' of NovoBliss Research who voluntarily wish to take part in this study. There are multiple techniques for establishing documentary evidence demonstrating that standardised procedural steps, processes and methods are carried out in testing for hairs care range of products to maintain the desired level of compliance.
It is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for the outcome of the processes.
Below listed test methods/techniques will be performed:
- Assessment of General appearance of hair (i.e. Hair Volume, Hair Density, Hair Reflection, Hair Plasticity, Hair Smoothness, Hair Oiliness, Shininess)
- Assessment of Scalp Appearance i.e. itchiness, dryness, redness, roughness, and scaliness of scalp
- Assessment of Adherent Scalp Flaking Score (ASFS)
- Assessment of Hair Strength (i.e. Poor, Average, Good)
- Assessment of Gray Hair - Graying Severity Score (GSS); Hair Whitening Score. Evaluation Methods
- 60-seconds hair count (Hair Combing Method)
- Hair Pull Test
- Trichogram (Pluck Test - Anagen: Telogen Ratio Calculation)
- Scanning Electron Microscope (SEM)
Instrumental Evaluation:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 performed study test methods
- •Subject is willing and able to follow the study directions, to 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
- •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
Evaluate the standardize the methods, procedural steps
时间窗: Day 01 to Day 04
Subjective scoring of Hair quality appearance and scalp condition
次要结局
未报告次要终点
研究者
Maheshvari Patel
Principal Investigator
NovoBliss Research Pvt Ltd