NCT05763888

Validation and Standardization of Test Methods and Evaluators for Testing of Hair Care Range of Products

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: * Phototrichogram - Tattoo Method for Hair Growth Rate, Hair Density, Hair Thickness, and Scalp Condition i.e. Scalp Dandruff - Using CASLite Nova * Scalp Hydration by MoistureMeterEpiD * Scalp Sebum level by Sebumeter * Hair Color by Hair/Skin Colorimeter CL 410 * Image analysis for Hair Growth Rates, number of hairs and length, and Gray hair counts, using Image-Pro Software * Assessment of Hair Cuticle - by Electron microscope to check parameters such as surface damage of hair, photodamage of outermost cuticle layer * Microbial changes in scalp flora by trichoscopy or dermoscopy.

Conditions

• Healthy Subject

Interventions

Type	Name	Description
OTHER	No drug will given	No intervention will be given to the subject

Timeline

• Start date: 2023-04-12
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2023-03-10
• Last updated: 2023-05-30

Locations

1 site across 1 country: India