| CTRI Number |
CTRI/2025/03/082628 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Cleaning Potential of Confiance Sunscreen Spf50 and Above (MT01) |
|
Scientific Title of Study
|
A Clinical Study to Evaluate Cleaning Potential of Confiance Sunscreen Spf50 and Above (MT01) on Healthy Human Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT502 Version 1.0 dated 07 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
UTTAR PRADESH
250002
India |
| Phone |
9027285265 |
| 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 |
| Confiance Life Sciences Pvt Ltd,1A, 5th Floor, A Wing, Times Square, Marol, Andheri East, Mumbai – 400059 |
|
|
Primary Sponsor
|
| Name |
Confiance Life Sciences Pvt Ltd |
| Address |
1A, 5th Floor, A Wing, Times Square, Marol, Andheri East, Mumbai – 400059 |
| 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 no 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH |
9027285265
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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product- Sunscreen SPF50 |
Take approx. 2 ml of test product on palm. Apply on the face, rinse well. Application: Once a day, Route of administration: Topical, Duration: 1 day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Gender: Male or Female with age 18-45
2) Subjects with Normal to Oily Skin
3) Subjects willing to give written informed consent
4) Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
5) Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
6) Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of 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 open sores or open lesions in the treatment area(s).
4. Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
5. Have participated in any interventional clinical trial in the previous 90 days.
6. Have a known sensitivity to any of the constituents of the test product including sensitivities.
7. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
8. Have not skin related issues |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cleansing efficacy score pollutant mix(0-4) |
15 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cleansing efficacy score waterproof makeup(0-4) |
15 min |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/03/2025 |
| 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="1" |
|
Recruitment Status of Trial (Global)
|
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
|
Test Product: Sunscreen Spf50 and Above
 Dose: Gently Use the Equate Daily Facial Cleanser For Normal To Oily Skin , Rinse Well.
Route of Administration: TopicalUsers are enrolled to Check the: 1.To Remove Excess Oil but does not strip skin of Protective oils 2. To Rinses Clean 3. To Removes excess surface Oils, dirt and makeup residues without drying skin out or leaving it feeling tight 4. Rinses clean without leaving any residue that may clog pores
The users are enrolled as per the inclusion and exclusion criteria, First, Use a mix of pollution dirt then rinse off with face wash, after 15 min assessment will be done. Then with sunscreen and with water proff makeup. |