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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.
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:
Instrumental Evaluation:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No drug will given | Other | No intervention will be given to the subject |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the standardize the methods, procedural steps | Validate the hair growth rate measurement | Day 01 to Day 04 |
| Evaluate the standardize the methods, procedural steps | 60-s combing test | Day 01 to Day 04 |
| Evaluate the standardize the methods, procedural steps | Hair Pull test | Day 01 to Day 04 |
| Evaluate the standardize the methods, procedural steps | Hair Pluck test | Day 01 to Day 04 |
| Evaluate the standardize the methods, procedural steps | Subjective scoring of Hair quality appearance and scalp condition | Day 01 to Day 04 |
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Inclusion Criteria:
Exclusion Criteria:
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Referring to the convenience sampling method which is a type of non-probability sampling, a total of 40 subjects will be enrolled. This technique involves selecting a research sample based on convenience & accessibility, drawing the sample from the part of the population close to hand.
In this study, the purpose is to standardize and validate the methods and evaluators' and there is no usage of medicines/test articles/test treatment or test products, specific sample calculation of sample size estimation is not required.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Nayan K Patel, MBBS | Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovoBliss Research Pvt Ltd | Gandhinagar | Gujarat | 382421 | India |
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