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CTRI Number  CTRI/2025/09/094121 [Registered on: 02/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [skin sensitivity test]  
Study Design  Single Arm Study 
Public Title of Study   A clinical study to check the UVA and UVB Protection of the test products 
Scientific Title of Study   A study to determine the UVA and UVB Protection Factor of Test product in Indian adult trial participants. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SKIN/QRUV/2025-02 Version 1.0, dated 31 July 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukta Sachdev 
Designation  Principal Investigator  
Affiliation  MS Clinical Research Pvt. Ltd  
Address  Department of Skin Sciences 324 Second Floor 1st Main Road Cambridge Layout Ulsoor
MS Clinical Research Pvt. Ltd 327/15,1st Main Road, Cambridge layout, Ulsoor 1st Main Road, Cambridge layout,
Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  mukta.sachdev@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Ritambhara 
Designation  Director- Business and operations 
Affiliation  MS Clinical Research Pvt. Ltd. 
Address  Department of Skin Sciences 324 Second Floor 1st Main Road Cambridge Layout Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  09080826918  
Fax    
Email  ritambhara@msclinical.com  
 
Details of Contact Person
Public Query  
Name  Sudhanthiran S 
Designation  manager- Techno commercial 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  Department of Skin Sciences 324 Second Floor 1st Main Road Cambridge Layout Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  09952700028  
Fax    
Email  sudhan@msclinical.com  
 
Source of Monetary or Material Support  
QUEST RETAIL PRIVATE LIMITED 
 
Primary Sponsor  
Name  QUEST RETAIL PRIVATE LIMITED 
Address  7th Floor, Infinity Tower A, DLF Cyber City, DLF Phase II, Gurugram – 122002, Haryana 
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
none   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mukta Sachdev  MS Clinical Research Pvt. Ltd  Department of Skin Sciences, #324, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA 		 08040917253

mukta.sachdev@msclinical.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ACE INDEPENDENT ETHICS COMMITTEE  Approved 
ACE INDEPENDENT ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  MALE AND FEMALE PARTICIPANTS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Daily Body Lotion (FND35826)  The test product will be applied at a dose of 2 milligrams per square centimeter to a defined area of 35 square centimeters (7 by 5 centimeters) on the upper back. A stencil will be used to ensure consistent application. Each test site will be divided into six sub-sites. The sixth sub-site will remain untreated and serve as the non-irradiated control. The other five sub-sites will receive incremental ultraviolet doses, with two receiving lower doses and three receiving higher doses, in accordance with ISO 24442 2022 guidelines. The third sub-site will be used for determining the UVAPF. 
Intervention  Daily Face Moisturizer (FND35828)  The test product will be applied at a dose of 2 milligrams per square centimeter to a defined area of 35 square centimeters (7 by 5 centimeters) on the upper back. A stencil will be used to ensure consistent application. Each test site will be divided into six sub-sites. The sixth sub-site will remain untreated and serve as the non-irradiated control. The other five sub-sites will receive incremental ultraviolet doses, with two receiving lower doses and three receiving higher doses, in accordance with ISO 24442 2022 guidelines. The third sub-site will be used for determining the UVAPF. 
Comparator Agent  P5 or P8 reference standard   The test product will be applied at a dose of 2 milligrams per square centimeter to a defined area of 35 square centimeters (7 by 5 centimeters) on the upper back. A stencil will be used to ensure consistent application. Each test site will be divided into six sub-sites. The sixth sub-site will remain untreated and serve as the non-irradiated control. The other five sub-sites will receive incremental ultraviolet doses, with two receiving lower doses and three receiving higher doses, in accordance with ISO 24442 2022 guidelines. The third sub-site will be used for determining the UVAPF. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Trial participant able to read, understand, and sign the informed consent form indicating willingness to participate in the study

2. Trial participants of both genders in the age group 18 to 55 years inclusive

3. Trial participants with a colorimetric ITA value in the range of 18 to 43 degrees, providing persistent pigmentation darkening to the UVA dose. Phototype of the trial participant will be recorded

4. Trial participants having a clear back with uniform color and no sunburn, tan, blemishes, cuts, wounds, injuries, allergies, or any skin condition on the test areas upper back region between scapula and waist that can hamper the assessment

5. Trial participants willing to discontinue the use of soaps and cosmetic products such as creams and moisturizers in the treatment areas throughout the course of the study

6. Trial participants willing to avoid any exposure of the test area to artificial or natural ultraviolet UV light throughout the course of the study

7. Trial participants willing to adhere to the study procedure, restrictions, and visiting the study site for follow-up visits at the specified date and time

8. Trial participants willing and capable of following the study rules and maintaining a fixed schedule

9. Trail participant in Good physical and mental health with, in the opinion of the investigator or medically qualified person 
 
ExclusionCriteria 
Details  1. Trial participants with sun tan, blemishes, photo-toxicity reactions, cuts, abrasions, wounds, injuries, allergic reactions (in the tested area).
2. Trial participants allergic to cosmetic products such as moisturizers, creams and body lotion or anything else.
3. Trial participants using anti-inflammatory medication.
4. Trial participants with systemic dermatological conditions (including dysplastic nevi).
5. Skin allergy antecedents or atopic trial participants.
6. Trial participants having history of or having active photo dermatitis.
7. Trial participants on any known medication for photosensitization. (eg. Oral diabetic medications, sulphur drugs, cancer chemotherapy)
8. Trial participants with cutaneous disease which may influence the study result.
9. Trial participants on oral corticosteroid in last 2 months.
10. Trial participants with a history of abnormal response to the sun or a history of skin cancer.
11. Trial participants participating in any other cosmetic or therapeutic study.
12. Trial participants presenting with existing sun damage in the test area.
13. Trial participants who are pregnant or lactating (self-declared)
14. Trial participants with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, hiv or any other serious medical illness.
15. Trial participants who have participated in a similar investigation in the past 8 weeks.
16. Trial participants who are currently an employee of MSCR or the sponsor
17. Trial Participants who have used self-tanning/SPF products on the back area in the previous 2 month prior to screening
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the UVA protection factor of the investigational products in reference to standard product in healthy adult trial participants.  Day 1,Day 2,Day 3,Day 4,Day 5,Day 6 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   N/A 
Date of First Enrollment (India)   15/09/2025 
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="6" 
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 monocentric, randomized, double-blinded, and controlled study is designed to evaluate the UVA protection efficacy (UVAPF) of sunscreen products using a standardized laboratory method. A calibrated solar simulator will be used to assess the level of protection the sunscreen provides against UVA-induced pigmentation on human skin. During the screening visit, participants will provide written informed consent and will be assessed for eligibility based on inclusion and exclusion criteria. A spectrophotometer will be used to measure the ITA° (Individual Typology Angle) value on the upper back to confirm suitability for the study. The Minimal Persistent Pigment Darkening Dose (MPPDDU) will be determined by exposing the test site to a series of five incremental UVA doses, identifying the lowest dose that causes visible and persistent pigmentation 2 to 24 hours after exposure. Once the MPPDDU is established, participants will proceed to the sunscreen test. Randomized sites on the upper back will be exposed to UVA—one without protection and others after the application of the test product and standard sunscreen. Visual assessments will be conducted 20 ± 4 hours after exposure to evaluate pigment darkening at each site. The UVA protection factor (UVAPFi) will be calculated for each participant as the ratio of the MPPDD at the test product site (MPPDDP) to the MPPDD at the untreated site (MPPDDU), reflecting the level of UVA protection offered by the product. 
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