| CTRI Number |
CTRI/2025/02/081184 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
safety and efficacy study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical study to determine the effectiveness of test product for Long-Lasting, Waterproof, and Smudge-Proof Results in Healthy Adult Human Female Participants |
|
Scientific Title of Study
|
A clinical safety and efficacy study of Kajal for Long-Lasting, Waterproof, and Smudge-Proof Results in Healthy Adult Human Female Subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250002-MS Ver 1.0, 05 Feb 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Clinical trial Department NovoBliss Research Pvt Ltd 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.
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 |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Clinical trial Department NovoBliss Research Pvt Ltd 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.
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 |
Clinical trial Department office 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Yojit Estate, A39, H. No. 35/139, Road No.11,
Wagale Estate, MIDC Landmark,
Near Old Passport Office,
Thane, Maharashtra 400604, India
|
|
|
Primary Sponsor
|
| Name |
Maxima Solutions |
| Address |
Yojit Estate, A39, H. No. 35/139, Road No.11, Wagale Estate, MIDC Landmark, Near Old Passport Office, Thane, Maharashtra 400604, India |
| Type of Sponsor |
Other [Manufacturer of personal care products ] |
|
|
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 |
| Dr Nayan Patel |
NovoBliss Research Pvt. Limited |
Clinical trial Department office 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.
Ahmadabad
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Frequent user of Kajal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kajal |
Dose: required amount
Dosage Form: Kajal Pencil
Route of Administration: Topical
Mode of Usage: Start applying at the inner corner of the eye and gently glide the outward along the upper lid. Repeat the application to the lower lid, ensuring a smooth and even line
Duration: 3 Days
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Age: 18 years and above old at the time of consent.
2. Sex: Healthy human non-pregnant/non-lactating females.
3. Frequent | Daily user of Kajal.
4. Females of childbearing potential must have a self-reported negative urine pregnancy test on Day 01 before application.
5. Females who are using contact Lenses (2 to 5 female participants).
6. Subjects are generally in good general health as determined from recent medical history.
7. The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results.
8. The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits.
9. The subject must be able to understand and provide written informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are visually impaired or having underlying conditions that potentially impairs their vision.
2. Subject with eye makeup.
3. Subjects with known history of allergies or specific allergic reactions upon using ophthalmic cosmetic products.
4. Subjects with presenting ophthalmic conditions like dry eye, cataract, conjunctivitis etc.
5. Subjects who have dark circles under their eyes.
6. Subjects who are reported pregnant/planning a pregnancy or lactating.
7. Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment.
8. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test product in terms of
1. change in long lasting effect
2. being water proof and smudge-Proof
3. Eye irritation, redness, itchiness, and lachrymation
4. Change in photograph
5. subjective questionnaire |
baseline before product application and after product application at T0 (within 10 mins) hours, T24 hours, and T36 hours of application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
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)
|
06/03/2025 |
| Date of Study Completion (India) |
27/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="3" |
|
Recruitment Status of Trial (Global)
|
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 open-label, single-arm, single centre clinical safety and efficacy study of Kajal for Long-Lasting, Waterproof, and Smudge-Proof Results in healthy human female subjects. A sufficient number (maximum of 32) of adult female subjects will be recruited to ensure a total of 30 subjects complete the study. Visit 01 (Day 00): Screening, ICD Obtained, Visit 02 (Day 01): Enrolment, Visual Assessment, Digital Photographs, ophthalmological evaluation (eye irritation, redness, itchiness, and lachrymation)
Visit 03 (Day 02): 24 hours visual assessment by trained staff, digital photographs, subject perception questionnaire Visit 04 (Day 02): 36 hours visual assessment by trained staff, digital photographs, subject’s perception questionnaire, end of study
| |