| CTRI Number |
CTRI/2025/10/095669 [Registered on: 07/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
SPF of Brinton UV- Doux Gold Sunscreen Gel |
|
Scientific Title of Study
|
An In-vivo Study to determine the Sun Protection Factor of Brinton UV- Doux Gold Sunscreen Gel HC250191 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT851 Version 1.0 dated 13 Sept 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09027285265 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| Brinton Pharmaceuticals Ltd, Brinton House, Survey No. 55/2,Kharadi, Pune - 411014, India |
| CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road, Meerut, UTTAR PRADESH-250005 |
|
|
Primary Sponsor
|
| Name |
Brinton Pharmaceuticals Ltd |
| Address |
Brinton House, Survey No. 55/2,Kharadi, Pune - 411014, 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 Robin Chugh |
CCFT laboratories |
CCFT Laboratories, 2nd floor, 2nd room, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH |
09027285265
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 |
Volunteers with 18 to 40, 41 to 55, and greater than 56 of age male-female |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product: UV- Doux Gold Sunscreen Gel HC250191 |
Quantity 2 mg/sq.cm Route of administration: Topical Frequency: Once Duration: 24 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Individual should have ITA angle in the range of 18 t0 40, 41 to 55, and greater than 56
2. Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the investigator.
3. Individuals who have completed a preliminary medical history evaluation.
4. Individuals who have read, understood and signed an informed consent document relating to the specific study to which they are subscribing.
5. Individuals with no known abnormal response to sunlight. |
|
| ExclusionCriteria |
| Details |
1.Individuals taking medication which in the opinion of the investigator would mask or interfere with the results.
2.Individuals with chronic skin allergies.
3.Individuals with suntan or sunburn.
4.Individuals with abnormal reaction to the sun.
5.Pregnant or lactating females.
6.Subjects accustomed to using sun beds.
7.Subjects who have participated in an SPF study within the last two months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Individual MED (iMED) score |
Day1, Day2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/10/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is the Invivo SPF test done as per UV-B protection ISO 24444 to determine the Sun Protection Factor
Test Product:
1. UV- Doux Gold Sunscreen Gel HC250191
Done on 10 human volunteers. Duration: 3 Days |