| CTRI Number |
CTRI/2024/12/078815 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use Test for Be Bodywise Ultra Light Sunscreen SPF50plus |
|
Scientific Title of Study
|
A Sensorial Assessment of the Be Bodywise Ultra Light Sunscreen SPF50plus in comparison with the 3 marketed products |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT426 Version 1.0 dated 12 Dec 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
|
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India 250002 |
| Mosaic Wellness Pvt. Ltd, 6th Floor, ThaneOne West – 400610 |
|
|
Primary Sponsor
|
| Name |
Mosaic Wellness Pvt. Ltd |
| Address |
6th Floor, ThaneOne West – 400610 |
| 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 |
AR multispecialty hospital and research center, 1st Floor room 3, Skin testing lab , CCFT laboratories, 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 |
Be Bodywise Ultra Light Sunscreen SPF50+ |
Test Product-Be Bodywise Ultra Light Sunscreen SPF50+ Route of Administration: Topical Frequency: Once Duration: 48hrs |
| Comparator Agent |
Comparators(A, B, and C) |
Route of Administration: Topical Frequency: Once Duration: 48hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Either gender- Male or Female with age 18 to 60
2. Cooperating, informed of the need and duration of the
examinations and ready to comply with protocol procedures.
3. For whom the investigator considers that the compliance will be correct.
4. Having signed a Consent Form.
5. Should be able to read and write (in English, Hindi or local
language).
6. Having valid proof of identity and age |
|
| ExclusionCriteria |
| Details |
1. Pregnant of Lactating mothers
2. Subject in an exclusion period or participating in another food, cosmetic or therapeutic study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| X% users observing change in each parameter |
T0, T+1min, T+2min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
07/01/2025 |
| 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="15" |
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
|
Sensorial Assessment of the Be Bodywise Ultra Light Sunscreen SPF50+ with 3 comparators
Test Product- Be Bodywise Ultra Light Sunscreen SPF50+ , and Comprators(A, B, C) Route of Administration: Topical Frequency: Once Duration: 48hrs
Data Processing: Average Parameters for Test (Avg from all the three sets), V/s Parameters for Comparator A, V/s Parameters for Comparator B, V/s Parameters for Comparator C, V/s Test. |