| CTRI Number |
CTRI/2023/11/059515 [Registered on: 03/11/2023] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Tear free test of Piramals Multiple Baby care products. |
|
Scientific Title of Study
|
A Single blind Clinical study to evaluate the eye stinging potential of Piramal’s Multiple Baby care products. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT130 Version 1.0 Dated 29 OCT 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ishika Gandhi |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
Ground Floor room 2 , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road Meerut
Meerut
UTTAR PRADESH
250002
India
Meerut
UTTAR PRADESH
250002
India |
| Phone |
|
| Fax |
|
| Email |
ishika02gandhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
First Floor, Room 4, Clinical Research Dept, Mittal Building, 121-B Mansarovar Ind Estate, Panchli Khurd, Baghpat Road Meerut
Meerut
UTTAR PRADESH
250002
India
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
First Floor, Room 4, Clinical Research Dept, Mittal Building, 121-B Mansarovar Ind Estate, Panchli Khurd, Baghpat Road Meerut
Meerut
UTTAR PRADESH
250002
India
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India |
| Piramal Pharma Limited,Ground floor, Agastya corporate park, LBS marg, Kamani junction kurla west, Mumbai 400-070, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Piramal Pharma Limited |
| Address |
Ground floor, Agastya corporate park, LBS marg, Kamani junction kurla west, Mumbai 400-070, Maharashtra, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
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 Ishika Gandhi |
CCFT laboratories |
Ground Floor room 2, CCFT laboratories, AR multispecialty hospital and research center, Delhi Road, Meerut Meerut UTTAR PRADESH
Meerut
UTTAR PRADESH
Meerut
UTTAR PRADESH |
9027285265
ishika02gandhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multiple Baby care products |
1. Little’s Organix Gentle Baby Body Wash
2. Little’s Organix Baby Shampoo
3. Little’s Organix Gentle Baby Body Wash (Sulphate Free)
4. Little’s Organix Baby Shampoo (Sulphate Free)
Route of Administration: Topical
Duration: 1 hour
Frequency: Once |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy males or females, 18 to 60 years with no medical conditions of the eyes as determined by the subjects medical history and confirmed by an ophthalmologist
2. Subjects not under any doctor care for ocular or peri orbital diseases
3. The subject will refrain from using contact lenses, any topical facial products, any eye drops, false eyelashes, make up, over the counter products, or cosmetics on their eyes, eyelids, eyelashes, or the periorbital areas of the face during the study. |
|
| ExclusionCriteria |
| Details |
1.Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
2.Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
3.Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
4.Have participated in any interventional clinical trial in the previous 30 days.
5.Have a known sensitivity to any of the constituents of the test product including sensitivities to cocoamidopropyl betaine, coumarin, Aloe barbadensis etc.
6.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
7.Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Change in lacrimation
•Change in conjunctival inflammation.
•Change in cornea and iris inflammation .
|
[Time frame 0-1 days]
[Time frame 0-1 days]
[Time frame 0-1 days]
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/11/2023 |
| 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="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In Visit 1/Day 0
Step 1: Firstly, the subject enrolls into the study as per
inclusion and exclusion criteria
Step 2: Assessment of the subject as per discussed above (refer to
study design)
In Visit 2/ Day 1
To check the irritation
potential of the Multiple Baby Care Products. |