Healthy SubjectNCT05763888
Validation and Standardization of Test Methods and Evaluators for Testing of Hair Care Range of Products
An observational study of Healthy Subject, run by NovoBliss Research Pvt Ltd at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- No drug will given
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 12 Apr 2023to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- No drug will given
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drug will givenOther
No intervention will be given to the subject
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the standardize the methods, procedural steps
Validate the hair growth rate measurement
Measured: Day 01 to Day 04
Evaluate the standardize the methods, procedural steps
60-s combing test
Measured: Day 01 to Day 04
Evaluate the standardize the methods, procedural steps
Hair Pull test
Measured: Day 01 to Day 04
Evaluate the standardize the methods, procedural steps
Hair Pluck test
Measured: Day 01 to Day 04
Evaluate the standardize the methods, procedural steps
Subjective scoring of Hair quality appearance and scalp condition
Measured: Day 01 to Day 04
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start12 Apr 2023
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maheshvari Patel, NovoBliss Research Pvt Ltd
- Investigators
- Dr. Nayan K Patel, MBBS, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763888
- Sponsor's protocol ID
- NB220039-NB
- Status last verified
- May 2023
- First submitted
- 28 Feb 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05763888
- Acronym / sponsor ID
- NB220039-NB
- Conditions
- Healthy Subject
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No drug will givenNo intervention will be given to the subject | Other | – |
Primary outcome
Evaluate the standardize the methods, procedural steps
Time frame: Day 01 to Day 04
Validate the hair growth rate measurement
Evaluate the standardize the methods, procedural steps
Time frame: Day 01 to Day 04
60-s combing test
Evaluate the standardize the methods, procedural steps
Time frame: Day 01 to Day 04
Hair Pull test
Evaluate the standardize the methods, procedural steps
Time frame: Day 01 to Day 04
Hair Pluck test
Evaluate the standardize the methods, procedural steps
Time frame: Day 01 to Day 04
Subjective scoring of Hair quality appearance and scalp condition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Nayan K Patel, MBBS study director
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subject, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the standardize the methods, procedural steps (time frame: Day 01 to Day 04). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.