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CTRI Number  CTRI/2024/06/068883 [Registered on: 13/06/2024] Trial Registered Prospectively
Last Modified On: 02/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [SPF and Water Resistance]  
Study Design  Other 
Public Title of Study   To check the sun protection ability and water resistance properties of the sunscreen product. 
Scientific Title of Study   A randomized study to evaluate the Sun Protection Factor and water resistance properties of a test product. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SKIN/TLSP/2024-02  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sukrutha S D 
Designation  Principal Investigators  
Affiliation  MS Clinical Research Pvt. Ltd 
Address  MS Clinical Research Pvt. Ltd, Department of Skin Sciences, #324, Second Floor, 1st Main Road, Cambridge layout Ulsoor, Bangalore-560008, Karnataka, India

Bangalore
KARNATAKA
560008
India 
Phone  8040917253  
Fax    
Email  dr.sukrutha@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Satyendra Kumar 
Designation  Sr. Manager - Clinical Research 
Affiliation  Transformative Learning Solution Pvt. Ltd. 
Address  Transformative Learning Solutions Pvt Ltd 3rd Floor, Veritas Business Suit, Sector 53, Gurugram, Haryana 122002

Gurgaon
HARYANA
122002
India 
Phone  9891253516  
Fax    
Email  satyendra.kumar@transformative.in  
 
Details of Contact Person
Public Query  
Name  Ritambara KR 
Designation  Director Business and operations 
Affiliation  MS Clinical Research Pvt. Ltd. 
Address  MS Clinical Research Pvt. Ltd, Department of Skin Sciences, #324, Second Floor, 1st Main Road, Cambridge layout Ulsoor, Bangalore-560008, Karnataka, India

Bangalore
KARNATAKA
560008
India 
Phone  8040917253  
Fax    
Email  ritambhara@msclinical.com  
 
Source of Monetary or Material Support  
Transformative Learning Solution Pvt. Ltd. 3rd Floor, Veritas Tower, Sector 53, Gurugram Gurgaon HARYANA 122002 India 
 
Primary Sponsor  
Name  Transformative Learning Solution Pvt. Ltd. 
Address  3rd Floor, Veritas Tower, Sector 53, Gurugram Gurgaon HARYANA 122002 India 
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sukrutha SD  MS Clinical Research  Department of Skin Sciences, #324, Second Floor, 1st Main Road, Cambridge layout Ulsoor, Bangalore-560008, Karnataka, India
Bangalore
KARNATAKA 		 9480769076

dr.sukrutha@msclinical.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Clinicom  Approved 
Clinicom  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy male and female participants 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gleam Beam Mineral Glow Sunscreen (LC 471/29)   Each product, about (2.00 ± 0.05) mg/cm2 will be applied. For each test site of 35cm2, 70mg of the test product will be applied using PDP pipette. 
Comparator Agent  Reference Standard Sunscreen P2  Each product, about (2.00 ± 0.05) mg/cm2 will be applied. For each test site of 35cm2, 70mg of the test product will be applied using PDP pipette. 
Comparator Agent  Reference Standard Sunscreen P8  Each product, about (2.00 ± 0.05) mg/cm2 will be applied. For each test site of 35cm2, 70mg of the test product will be applied using PDP pipette. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Subject able to read, understand and sign on informed consent form indicating willingness to participate in the study.
2. Subjects of both genders in the age group of 18 to 55 years (both the ages inclusive).
3. Test subjects shall have an ITA degree value of at least 28 degree by colorimetric methods and be untanned on the test area that is back area.
4. The average of the subjects making up a test panel shall have an ITA degree between 41 and 55. [When possible, there should be subjects with ITA degrees in each of the three ITA degree bands, 28 degree to 40degree, 41degree to 55 degree, and more than 56°. Where this is not possible, there shall be at least three individuals in each of two of the three ITA degree bands described in the previous sentence].
5. The test sites intended for UV exposure shall be free from blemishes and hair, and have an even colour tone with no variation in ITA degree greater than 5 degree from each other or the MEDu test area.
6. Subjects willing to undergo water immersion testing, ensuring that the upper body or test sites remain submerged during a simulated swim test device.
7. Subjects willing to discontinue the use of soaps and cosmetic product (e.g. creams, moisturizers) in the test areas throughout the course of the study.
8. Subject willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study.
9. Subjects willing to adhere to the study procedure, restrictions and visiting the study site for follow up visits at the specified date and time.
10. Subjects with no known abnormal response to sunlight.
11. Subjects willing and capable to follow the study rules and a fixed schedule.



 
 
ExclusionCriteria 
Details  Subjects with suntan, blemishes, photo-toxicity reactions, cuts, abrasions, wounds, injuries, allergic reactions (in the test area).
2. Subjects allergic to cosmetic product such as moisturizers, creams and body lotion or anything else.
3. Skin allergy antecedents or atopic subjects.
4. Subjects having history of or having active photo dermatitis.
5. Subjects on any known medication for photosensitization. (e.g. oral diabetic
medications, Sulphur drugs, cancer chemotherapy)
6. Subjects with cutaneous disease which may influence the study result.
7. Subjects on oral corticosteroid in last 2 months.
8. Subjects participating in any other cosmetic or therapeutic study.
9. Subjects who are pregnant or lactating (self-declared)
10. Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
11. Subjects who have participated in a similar investigation in the past 8 weeks.
12. Subjects who are currently an employee of MSCR or the sponsor.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the sun protection factor of the test product in reference to standard product in healthy adult subjects.
2.To evaluate water resistance properties of the test product.
 		 N/A 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   17/06/2024 
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="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 study aims to assess the sun protection factor (SPF) and water resistance of a specific sunscreen product. By evaluating SPF efficacy and water immersion performance, of the product in comparison with standard reference. 
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