| CTRI Number |
CTRI/2023/11/059370 [Registered on: 01/11/2023] Trial Registered Prospectively |
| Last Modified On: |
16/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety and Efficacy Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to determine the efficacy of the test product for its Long Lasting Effect in Healthy Adult Human Female Subjects |
|
Scientific Title of Study
|
A Proof-of-Concept, Efficacy Study of Midnight Kohl Pencil for Long Lasting Effect in Healthy Adult Human Female Subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB230033-RC Version Final 1.0, 09 Oct 23 |
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 |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex,
Near Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| 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 |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex,
Near Vaishnodevi Circle, Khoraj
GUJARAT
382421
India |
| Phone |
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 |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Renee Cosmetics Private Limited
4, OM Complex, 2nd Floor,
Swastik Char Rasta, C.G. Road
Ahmedabad, Gujarat, India
|
|
|
Primary Sponsor
|
| Name |
Renee Cosmetics Private Limited |
| Address |
4, OM Complex, 2nd Floor,
Swastik Char Rasta, C.G.Road,
Ahmedabad, Gujarat, India - 380009
|
| Type of Sponsor |
Other [ [Manufacturer, Distributer, Selling]] |
|
|
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 |
Office-A - 206, 2nd
Floor, Shaligram
Lakeview Business
Complex, Near
Vaishnodevi Circle,
Khoraj
Gandhinagar
GUJARAT
Gandhinagar
GUJARAT |
9909013286
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 users of kajal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Midnight Kohl Pencil |
Frequency: Once a Day
Route of Administration: Topical
Duration: 24 hours
Mode of Usage: Start with the inner corner of your eye and gently move outwards on your upper lid. Repeat on the lower lid.
Dose: Single application of the test product on upper and lower eyelid. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Age: 18 to 50 years (both inclusive) old at the time of consent.
2.Sex: Healthy human non-pregnant/non-lactating females.
3.Frequent user of kajal.
4.Females of childbearing potential must have a self-reported negative urine pregnancy test on Day 01 before application.
5.Subjects are generally in good general health as determined from recent medical history.
6.The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results.
7.The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits.
8.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 are regular users of prescription or cosmetic contact lens.
6.Subjects who have dark circles under their eyes.
7.Subjects who are reported pregnant/planning a pregnancy or lactating.
8.Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment.
9.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
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To evaluate the long-lasting effect of the test product |
From baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the effect of the test product for being smudge-free |
from the baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours |
| 2.To assess the safety of the test product at the periocular region in terms of eye irritation, redness, itchiness, and lachrymation |
From baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours |
| 3.Change in photographs (Eye area) |
From baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours |
| 4.To assess the effect of the test product in terms of product perception questionnaire |
From baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours |
|
|
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)
|
13/11/2023 |
| Date of Study Completion (India) |
01/12/2023 |
| 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)
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 open label, single-arm, single centre, proof of concept, efficacy, clinical study of Midnight Kohl Pencil in healthy human female subjects. The adult subjects will be instructed to visit the facility as per the below visits: Visit 01(Day 01): Screening Visit 02 (Day 02): Enrolment and Evaluations Visit 3 (Day 03): End of Study
|