| CTRI Number |
CTRI/2025/08/092569 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [[cosmetic product for efficacy and safety evaluation]] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
long-lasting efficacy of The Body Shop Eye Define Kajal Bold Black in healthy female participants |
|
Scientific Title of Study
|
A monocentric, single arm, open-label prospective clinical study to assess the long-lasting efficacy of The Body Shop Eye Define Kajal Bold Black in healthy adult human female participants. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARL-CT-025-25 Version 01 Dated 11-Jul-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karishma Kapoor |
| Designation |
Principle Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
New Delhi
DELHI
110015
India |
| Phone |
09871953143 |
| Fax |
|
| Email |
karishma.kapoor@aurigaresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karishma Kapoor |
| Designation |
Principle Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India |
| Phone |
09871953143 |
| Fax |
|
| Email |
karishma.kapoor@aurigaresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karishma Kapoor |
| Designation |
Principle Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India |
| Phone |
09871953143 |
| Fax |
|
| Email |
karishma.kapoor@aurigaresearch.com |
|
|
Source of Monetary or Material Support
|
| Quest Retails private Limited
DLF Infinity tower A 7th Floor DLF Cyber city M G Road Gurgaon 122002 DLF phase 2 |
|
|
Primary Sponsor
|
| Name |
Quest Retails private Limited |
| Address |
DLF Infinity tower A 7th Floor DLF Cyber city M G Road Gurgaon 122002 DLF phase 2 |
| Type of Sponsor |
Other [Cosmetic manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karishma Kapoor |
Auriga Research Private Limited |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India
New Delhi
DELHI |
09871953143
karishma.kapoor@aurigaresearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society for Ethical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
The Body Shop Eye Define Kajal Bold Black |
The product will be applied only once on baseline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Participant in generally good health
Participant between the age group of 18 and 45 years Participant has not participated in a similar clinical investigation in the past four weeks
Participant willing to abstain from using any product besides the provided product during the entire study course
v. Participant is a frequent user of makeup products
Participant is non-user of Contact Lenses/ Frequent user of Contact Lenses
Participant willing to comply with study specific requirements
Participant willing to give a written informed consent and come for regular observation |
|
| ExclusionCriteria |
| Details |
Participant is having a history of allergy of or hypersensitivity to any eye cosmetics kajal eyeliner ingredients or any ophthalmic products
Presence of active or recent eye infections e g conjunctivitis blepharitis
Any skin condition affecting the eyelids or surrounding area e g eczema dermatitis psoriasis
Participant under any dermatological treatment / prescribed medications.
Currently or has been undergoing dermatologist facial treatments or procedures within the last 1 month
Participant viewed by the Dermat as not being able to complete the study or participating in another study
Participant is Pregnant or Lactating
Participant with any significant medical condition that would interfere with the participation in the trial |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| long-lasting efficacy of The Body Shop Eye Define Kajal Bold Black |
0 hrs 2 hr 6 hrs 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and tolerability of investigational product |
0 hrs 2 hr 6 hrs 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
A monocentric, open-label, single arm prospective clinical study.
Twenty-five adult female participants
in the age group of 18 years to 45 years with nearly equal representation of
all skin types will be selected according to inclusion and exclusion criteria
and Frequent
Contact lens users and non-contact lens users (approximately in equal ratio). Dermatological, Ophthalmological and Participant Self assessments will be performed at specified time points. The allocated The Body Shop Eye Define Kajal Bold Black will be applied on the participant’s test sites (Eyes and surrounding area). The Long Lasting efficacy of the product will be evaluated. |