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CTRI Number  CTRI/2024/01/061874 [Registered on: 25/01/2024] Trial Registered Prospectively
Last Modified On: 05/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Safety, Efficacy Study]  
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A clinical study to determine the safety and efficacy of eyebrow and eyelash growth serums. 
Scientific Title of Study   Proof-of-concept, Open-Label, Two-Arm, Parallel, In-Use Safety and Efficacy Study of test products: ‘RE-Do Beauty Eyebrow Enhancing Serum’ and ‘RE-Do Beauty Eyelash Enhancing Serum’. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NB230046-VC_Version_Final(1.0)_06Jan24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Principal Investigator - Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj

Gandhinagar
GUJARAT
382421
India 
Phone  09909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator - Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj


GUJARAT
382421
India 
Phone  09909013286  
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  NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj

Gandhinagar
GUJARAT
382421
India 
Phone  09909013236  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
V2.0 Cosmetics LLP, Noida 
 
Primary Sponsor  
Name  V2.0 Cosmetics LLP 
Address  D-146, Sector 61, Noida – 201301, Uttar Pradesh, India 
Type of Sponsor  Other [Personal Care] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nayan Patel  NovoBliss Research Private Limited  Clinical Trails Department, NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT 		 09909013286

dr.nayan@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy female subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  RE-Do Beauty Eyebrow Enhancing Serum  Route of Administration: Topical Mode of usage: Apply directly on natural eyebrow shape, once daily before bedtime. Total Duration:45 Days 
Intervention  RE-Do Beauty Eyelash Enhancing Serum  Route of Administration: Topical Mode of usage: Apply directly on the lash line where follicles are present, once daily before bedtime. Total Duration:45 Days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. The subject is aged between 18 and 45 years (both inclusive) at the time of informed consent.
2. The subject is a non-pregnant, non-lactating, healthy adult female.
3. The subject has a self-reported negative urine pregnancy test.
4. The subject is in a good general health as determined from recent medical history.
5. The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results.
6. The subject has willingness and ability to adhere to study directions, participate in the study, and return for all specified visits.
7. The subject possesses the ability to comprehend and provide written informed consent for participation in the study.
8. The subject agrees not to use any medicated or prescription or other eyebrow and eyelash hair growth products or drugs other than the test product throughout the entire study duration.
9. The subject agrees to refrain from undergoing any type of cosmetic or salon enhancement or grooming during the period of the study.
10. Few subjects wearing contact lenses shall be included in the study.
11. Subjects with sensitive eyes, experiencing lachrymation or mild irritation due to exposure to topical chemicals or strong fumes, will be included in the study, aiming for an equal proportion compared to subjects with non-sensitive eyes.
 
 
ExclusionCriteria 
Details  1. The subject is currently pregnant or lactating or is planning to become pregnant during the study period.
2. The subject is visually impaired or has any underlying condition that may potentially impair their vision.
3. The subject has a history of allergies or specific allergic reactions upon using ophthalmic cosmetic products.
4. The subject is presenting any ophthalmic condition including but not limited to dry eye, cataract, conjunctivitis.
5. The subject experienced stinging or discomfort of anything greater than 0 in the ophthalmic pre-evaluation done with isotonic saline solution.
6. The subject is currently enrolled in an active investigational study or has participated in an investigational study within 30 days prior to enrolment.
7. The subject suffers from any active clinically significant disease or any condition that according to the discretion of the investigator warrants exclusion from the study.
8. The subject is taking or has taken a medication which, in the judgement of the Investigator, makes the subject ineligible or places the subject at undue risk.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To assess changes in eyebrow growth parameters in terms of hair count, thickness, and density using CASLite Nova.
2. To assess changes in eyelash growth parameters in terms of in hair length and coverage area using Image Pro software.
 		 On Day 1 before product application and subsequently on Days 21 and 45 
 
Secondary Outcome  
Outcome  TimePoints 
Ophthalmic scoring evaluation by an ophthalmologist-trained evaluator and an ophthalmologist for irritation, stinging or discomfort effect, and the degree of inflammation of bulbar conjunctiva, palpebral conjunctiva, and lachrymation.  On Day 01 (after test product application), Day 21, and Day 45  
Local tolerability assessment by a dermatologist-trained evaluator and a dermatologist, for dermal safety scoring near the eye area before and after product application – evaluating skin irritation, redness, itchiness, and lachrymation.  On Day 01 (after test product application), Day 21, and Day 45. 
Digital photography of the eye area, specifically inclusive of eyelashes and eyebrows, will be taken to evaluate visual changes.  On Day 01 (before and after test product application), Day 21, and Day 45. 
Consumer perceptions about product usage, with a focus on sensorial attributes, will be assessed using a 5-point Likert scale (Appendix II).  On Day 21 and Day 45. 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/02/2024 
Date of Study Completion (India) 14/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is an open-label, in-use safety and efficacy study of two hair growth serums for eyebrow and eyelash.

A maximum of 32 female subjects will be recruited to ensure the completion of the study with a total of 30 subjects.

Subjects shall be instructed to visit the facility for the following scheduled visits:

1.       Visit 01 (Day 01): Screening, enrolment, baseline evaluations, and commencement of treatment phase.

2.       Visit 02 (Day 21): Safety and efficacy parameters evaluation.

3.       Visit 03 (Day 45): End-of-study visit including safety and efficacy parameters evaluation.


 
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