| CTRI Number |
CTRI/2023/10/058989 [Registered on: 20/10/2023] Trial Registered Prospectively |
| Last Modified On: |
20/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Other |
|
Public Title of Study
|
Determine the sun protection factor of the Dry touch Sunscreen gel |
|
Scientific Title of Study
|
An In-Vivo Study to Determine the Sun Protection Factor of the Dry touch Sunscreen gel |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT124 Version 1.0 Dated 4 Oct 2023 |
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
Meerut
UTTAR PRADESH
250002
India
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 |
First Floor, Room 4, Clinical Research Dept, Mittal Building,
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,
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-250002, India |
| NG Electro Product Private Limited
A-18 Sector 23, Noida, 201301 |
|
|
Primary Sponsor
|
| Name |
NG Electro Product Private Limited |
| Address |
A-18 Sector 23, Noida, 201301 |
| 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
multisepciality hospital
and research center,
Delhi Road, Meerut
Meerut
UTTAR PRADESH
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 |
Dry Touch Sunscreen Gel
|
Quantity2 mg/sq.cm
Route of administration: Topical
Frequency: Once Duration: 1
hour |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
1.Age 18-70 years
2.Individual should have ITA angle in the
range of 28-40, 41-55 and >56.
3.Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the investigator.
4.Individuals who have completed a preliminary medical history evaluation.
5.Individuals who have read, understood and signed an informed consent document relating to the specific study to which they aresubscribing.
6.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, Day 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the redness of skin
Delayed Erythema Response |
Day1, Day2
|
|
|
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)
|
20/10/2023 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
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
|
The product would be tested as per the guideline- International Standard ISO 24444 and ISO 16217 |