| CTRI Number |
CTRI/2022/07/043782 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
05/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of eye safety of test product |
|
Scientific Title of Study
|
To evaluate Ophthalmological safety of test product involving subjects of normal eye conditions on healthy female subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-6Y01-DD-JE22; Version: 01; Dated: 18/06/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
| Mascot Spincontrol India Pvt. Ltd., 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India |
|
|
Primary Sponsor
|
| Name |
ONESTO LABS PVT LTD |
| Address |
Plot 592, Phase - V,
Udyog Vihar, Gurugram – 122016 |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Janaki Y Kodkani |
Mascot Spincontrol India Pvt. Ltd. |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA |
02243349191
janaki@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having normal eye conditions. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chemist at play under eye cream |
Product to be applied on under eye area, Twice a day application for period of 4 days. |
| Comparator Agent |
NIL |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Indian Female subjects
2. Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup)
3. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
4. Having normal eye conditions
5. Having habit of using under eye cream
|
|
| ExclusionCriteria |
| Details |
6. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
7. Having refused to give his/her assent by not signing the consent form
8. Taking part in another study liable to interfere with this study
9. Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
10. Having a progressive asthma (either under treatment or last fit in the last 2 years)
11. Being epileptic.
12. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
13. Having cutaneous hypersensitivity
14. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
15. Following a chronic medicinal treatment comprising any of the following products: aspirin based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
16. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
17. Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
18. Having applied a cosmetic product (included make-up) or skin care product on the studied areas the first day of the study (only face cleaned with water is accepted)
19. Refusing to follow the restrictions below during the study: Do not take part in any family planning activities leading to pregnancy and breastfeeding Do not take part in another study liable to interfere with this study Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). Mascot Spincontrol 10 / 21 Product A XXX-6Y01-DD-JE22-XXX-PR (V01) Reference of the specification SPE-CNL-PM02-Main Part of Protocol-02-I This document is the property of Mascot Spincontrol. D:QASTUDY DOCUMENTSXXX-6Y01-DD-JE22XXX-6Y01-DD-JE22-XXX- PR (V01) 2022 06 18.docx Do not change cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit. During the study: Do not use other eye related and/ or eye make up than the tested products to the studied areas. The day of the measurements: No test product or any other eye make up must be used
20. Having applied make-up products on eyes in the 48 hours preceding the start of the study.
21. Having permanent make-up on the studied area.
22. Having ocular problems (stye, chalazion, conjunctivitis).
23. Having applied an eye product and/or make up for eye, to the studied area the day of the measurements.
24. Do not itch the eyes
25. Do not use any eye drops or any eye treatment/ surgery during the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Opthalmological Safety |
T0, 30 minutes, day 1, Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
06/07/2022 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objective: To evaluate Ophthalmological
safety of test product involving subjects of normal eye conditions on healthy
female subjects.
Duration of study: 4 days study
Kinetics: T0 (before product
application), T+30 minutes after product application, T+1 day, T+3 days
Population: 33 healthy female subjects
Techniques Involved are;
1. Subject Self
Evaluation: for product safety,
2. Opthalmological
evaluation :The test area is checked for irritation caused due to the products.
The parameters to be evaluated are; 1.
Redness 2. Watery eyes 3. Dryness 4. Itching 5. Irritation 6. Burning of eyes. |