| CTRI Number |
CTRI/2023/02/050050 [Registered on: 24/02/2023] Trial Registered Prospectively |
| Last Modified On: |
25/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Validation Study for Testing Methods |
| Study Design |
Other |
|
Public Title of Study
|
An experimental study for methods, tests, subjective assessments used to check safety and effectiveness of Hair Care Range of Products. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB220039-NB Version 01 Date 27Jan23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Medical Director Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj
Gandhinagar
GUJARAT
382421
India
Gandhinagar
GUJARAT
382421
India |
| Phone |
91-9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Medical Director Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj
Gandhinagar
GUJARAT
382421
India
Gandhinagar
GUJARAT
382421
India |
| Phone |
91-9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj
Gandhinagar
GUJARAT
382421
India
Gandhinagar
GUJARAT
382421
India |
| Phone |
91-9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| NovoBliss Research Private Limited Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj, Gandhinagar - 382421, Gujarat |
|
|
Primary Sponsor
|
| Name |
NovoBliss Research Private Limited |
| Address |
Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj Gandhinagar 382421 Gujarat |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Maheshvari Patel |
NovoBliss Research Private Limited |
Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj Gandhinagar 382421 Gujarat
Gandhinagar
GUJARAT |
9909013286
maheshvari@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subject is in good general health as determined by the Investigator on the basis of medical history |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL- Not Applicable |
NIL- Not Applicable |
| Comparator Agent |
NIL- Not Applicable |
NIL- Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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 perform study test methods.
6) Subject is willing and able to follow the study directions, 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.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The objective of this validation study is to evaluate the standardize the methods, procedural steps, validate the hair growth rate measurement, 60-s combing test, pull test, pluck test, subjective scoring of Hair quality appearance and scalp condition - evaluations techniques that are used during the conduct of clinical safety and efficacy studies for hair care product evaluation at/by NovoBliss Research on healthy adult human subjects |
Day 01 and Day 04 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Not Applicable
|
NONE |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2023 |
| Date of Study Completion (India) |
01/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="4" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an In-house process validation
study.
This
validation study will be carried out on/by study staff of the NovoBliss
Research who is voluntarily wish to take part in this internal validation
study. There are multiple hair evaluation techniques involved for testing hair
growth products these testing methods for establishing documentary evidence
demonstrate that standardised procedural steps, processes and methods carried
out in testing for hair care safety and efficacy studies to maintain the
desired level of compliance.
It is very
important that in addition to final testing and compliance of products during
an actual clinical study, it is also assured that the processes will
consistently produce consistent results. The consistent results are established
in terms of specifications for the outcome of the process. |