| CTRI Number |
CTRI/2024/04/066535 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Determine the sun protection factor of the Ceramide & Vitamin C Sunscreen. |
|
Scientific Title of Study
|
An in-Vivo Study to Determine the Sun Protection Factor of Ceramide & Vitamin C Sunscreen |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT175 Version 1.0 dated 14 Feb 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
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
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 Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, First floor, 135, Delhi Rd, besides Ramleela ground, New Punjabi Pura, Meerut, Uttar Pradesh 250002 |
| Honasa Consumer Ltd., 422/2 F Building. GIDC Pandesara, Surat, Gujrat - 394221 |
|
|
Primary Sponsor
|
| Name |
Honasa Consumer Ltd. |
| Address |
422/2 F Building. GIDC Pandesara, Surat, Gujrat - 394221 |
| 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
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 |
Ceramide & Vitamin C |
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 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18-70 years.
2.Individual should have ITA angle in the range of 28-40, 41-55 and more than 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 are subscribing.
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 |
Day 1 and 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)
|
10/05/2024 |
| 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
|
The below products would be tested as per the guideline International Standard ISO 24444 and ISO 16217
Product Name Ceramide & Vitamin C Sunscreen The study would be to estimate the SPF- sun protection factor |