Validation and Standardization of Test Methods and Evaluators for Testing of Hair Care Range of Products
Condition: Healthy Subject
Study type: Observational

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.
    

Intervention name(s): No drug will given
Intervention type(s): Other
Intervention description(s): No intervention will be given to the subject
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.