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

Healthy Subject Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05763888
• Other study ID #: NB220039-NB
• Status: Completed
• Start date: April 12, 2023
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: NovoBliss Research Pvt Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age: 18 - 75 years (both inclusive) at the time of consent.

2. Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).

3. Females of childbearing potential must have a self-reported negative urine pregnancy.

4. Subject is in good general health as determined by the Investigator on the basis of medical history.

5. Subject is willing and able to follow and allow study staff to performed study test methods

6. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.

7. Subject must be able to understand and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Subject have history of allergy to any ink.

2. Subject have participated any clinical research study related to hair care products.

3. 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.

5. Subject having known history of any skin diseases including eczema, atopic dermatitis or active cancer.

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Other:
• No drug will given
No intervention will be given to the subject

Locations

Country	Name	City	State
India	NovoBliss Research Pvt Ltd	Gandhinagar	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
NovoBliss Research Pvt Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the standardize the methods, procedural steps	Validate the hair growth rate measurement	Day 01 to Day 04
Primary	Evaluate the standardize the methods, procedural steps	60-s combing test	Day 01 to Day 04
Primary	Evaluate the standardize the methods, procedural steps	Hair Pull test	Day 01 to Day 04
Primary	Evaluate the standardize the methods, procedural steps	Hair Pluck test	Day 01 to Day 04
Primary	Evaluate the standardize the methods, procedural steps	Subjective scoring of Hair quality appearance and scalp condition	Day 01 to Day 04