| CTRI Number |
CTRI/2024/10/074791 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| 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 Activity of Brainbees Babyhug Daily Face & body Milky Foam Wash |
|
Scientific Title of Study
|
A Clinical Study to Evaluation Of Tear Free Potential of Brainbees Babyhug Daily Face & body Milky Foam Wash on Healthy Human Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT 329 Version 1.0 dated 04 Sep 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
7078103723 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
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 |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| Brainbees Solutions Ltd, Rajashree Business Park Sangamwadi, Pune, Maharashtra 411001 |
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India, 250002 |
|
|
Primary Sponsor
|
| Name |
Brainbees Solutions Ltd. |
| Address |
Rajashree Business Park Sangamwadi, Pune, Maharashtra 411001 |
| 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 Robin Chugh |
CCFT laboratories |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH |
7078103723
robinderm25@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 |
Baby Hug Daily Face & Body Milky Foam Wash |
1.Baby Hug Daily Face & Body Milky Foam Wash, 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 |
65.00 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 |
1.Change in lacrimation
2.Change in conjunctival inflammation.
3.Change in cornea and iris inflammation . |
Time Points 0-1 days
Time Points 0-1 days
Time Points 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)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="1" |
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
|
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 Brainbees babyhug Daily Face & body milky foam wash |