| CTRI Number |
CTRI/2023/03/050979 [Registered on: 22/03/2023] Trial Registered Prospectively |
| Last Modified On: |
06/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety checking of Product on eyes |
|
Scientific Title of Study
|
To evaluate Ophthalmological safety of test product involving subjects of normal eye conditions & contact lens user on healthy female subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-6F01-DT-FR23; Version: Final 01; Dated: 03/03/2023 |
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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai
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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| MASCOT-SPINCONTROL India Pvt. Ltd. 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai MAHARASHTRA 400013 India |
|
|
Primary Sponsor
|
| Name |
DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED |
| Address |
3002, 30th Floor, Beau Monde, Tower B, Prabhadevi Road, Prabhadevi, Mumbai - 400025 |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Raji Patil |
Mascot Spincontrol India Pvt. Ltd. |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. MAHARASHTRA 400013 India
Mumbai
Mumbai
MAHARASHTRA |
02243349191
raji@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 & contact lens user, having habit of using face wash |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Not applicable |
| Intervention |
Oil Balancing Cleanser (FR-010-19) |
The whole face to be washed with the test product. The face to be washed twice in a day for the period of 4 days. |
|
|
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)Between 18 and 40 years of age.
4)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
5)Subjects having normal eye conditions & contact lens user, having habit of using face wash.
|
|
| ExclusionCriteria |
| Details |
1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2 Having refused to give her assent by not signing the consent form.
3 Taking part in another study liable to interfere with this study.
4 Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months).
5 Having a progressive asthma (either under treatment or last fit in the last 2 years)
6 Being epileptic.
7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months).
8 Having cutaneous hypersensitivity.
9 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
10 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).
11 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
12 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
13 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).
14 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).
- 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. (only test cleanser is accepted)
- The day of the measurements: No test product or any other eye make up must be used (only face cleaned with water is accepted)
15 Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, A.H.A….) in the 2 weeks preceding the start of the study.
16 Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp …) in the previous 2 weeks.
17 Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 1 month
18 Having had beauty treatment (e.g. scrub, self-tanning product …) on the studied areas in the previous week.
19 Having permanent make-up on the studied area.
20 Having ocular problems (stye, chalazion, conjunctivitis).
21 Having applied a cosmetic eye product (included eye make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted).
22 Refusing to follow the restrictions below during the study:
- Do not start, change or stop a hormonal treatment (hormonal contraception, cyproterone acetate …).
- Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …).
- Do not itch the eyes.
- Do not wear lenses till the end of the study.
- 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 |
| Ophthalmological safety |
Baseline, 30 minutes, Day 1 and Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2023 |
| Date of Study Completion (India) |
06/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The objective of this study will be to evaluate Ophthalmological
safety of test product involving subjects of normal eye conditions &
contact lens user on healthy female subjects coded:
Oil Balancing Cleanser (FR-010-19) :
Product A
The
evaluation is performed using:
Subject Self Evaluation (SSE)
Ophthalmological Evaluation: Safety
The study lasts 4 days following the first
application of the product.
33 female subjects are selected for the study.
The subjects selected for this study are healthy female
subjects, aged between 18 to 40 years, having normal eye conditions &
contact lens user, having habit of using face wash. Kinetics
T0, T+30 minutes after
product application, T+1 day, T+3 days
|