| CTRI Number |
CTRI/2025/08/093399 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| 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 test the SPF of the test product. |
|
Scientific Title of Study
|
A study to determine the Sun Protection Factor of Test product in Indian adult trial participants |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/QRSP/2025-01 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
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 |
327/15,1st Main Road, Cambridge layout, Ulsoor
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 |
327/15,1st Main Road, Cambridge layout, Ulsoor
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
7th Floor, Infinity Tower A,
DLF Cyber City, DLF Phase II,
Gurugram – 122002, Haryana, India |
|
|
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
|
|
|
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
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
male and female participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
P8 reference standard (on at least 5 participants) and P2 on the remaining participants. |
Standard will be applied at 2 mg per cm2 on upper back sites 35 cm2 (7 by 5 centimeters) each with participants in prone position. Each site will be divided into six sub-sites five exposed to incremental UV doses and one as a control zero exposure. SPF evaluation will follow ISO 24444 guidelines with readings taken 15 minutes post application. |
| Intervention |
The Body Shop SUN DEFENCE - Daily Body Lotion (FND35826) |
Test product will be applied at 2 mg per cm2 on upper back sites 35 cm2 (7 by 5 centimeters) each with participants in prone position. Each site will be divided into six sub-sites five exposed to incremental UV doses and one as a control zero exposure. SPF evaluation will follow ISO 24444 guidelines with readings taken 15 minutes post application. |
| Intervention |
The Body Shop SUN DEFENCE - Daily Face Moisturizer (FND35828) |
Test product will be applied at 2 mg per cm2 on upper back sites 35 cm2 (7 by 5 centimeters) each with participants in prone position. Each site will be divided into six sub-sites five exposed to incremental UV doses and one as a control zero exposure. SPF evaluation will follow ISO 24444 guidelines with readings taken 15 minutes post application. |
|
|
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 on informed consent form indicating willingness to participate in the study.
2. Trial participants of both genders in age group 18 – 55 years (both the ages inclusive).
3. Participants selected for the SPF test must have an Individual Typology Angle (ITA) value of at least 28 degrees as measured by colorimetric methods and should have untanned skin on the test area (i.e., back)
4. The average ITA value of participants in the test panel must fall between 41 and 55 degrees. If possible, participants should be selected from all three ITA bands: 28 to 40 degrees, 41 to 55 degrees, and greater than 56 degrees. If not feasible, there must be at least three participants from any two of these three bands
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° greater than 5° from each other or the MEDu test area
6. Trial participants willing to discontinue the use of soaps and cosmetic products (e.g. creams, moisturizers) in the treatment areas throughout the course of the study.
7. Trial participant willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study.
8. Trial participants willing to adhere to the study procedure, restrictions and vising the study site for follow up visits at the specified date and time.
9. Trial participants willing and capable to follow the study rules and a fixed schedule.
10. Trial 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, marks 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. Skin allergy antecedents or atopic trial participants.
4. Trial participants having history of or having active photo dermatitis.
5. Trial participants on any known medication for photosensitization. (eg. oral diabetic medications, Sulphur drugs, cancer chemotherapy)
6. Trial participants with cutaneous disease which may influence the study result.
7. Trial participants on oral corticosteroid in last 2 months.
8. Trial participants using anti-inflammatory medication
9. Trial participants with systemic dermatological conditions (including dysplas-tic nevi);
10. Trial participants with a history of abnormal response to the sun
11. Trial participants presenting with existing sun damage in the test area
12. Trial participants participating in any other cosmetic or therapeutic study.
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 products on the back area in the previous 1 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 |
| the sun protection factor of the investigational products in reference to standard product in healthy adult trial participants. |
UV exposure Day
Assessment day (+24 hours)
UV exposure Day
Assessment day (+24 hours) |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
03/09/2025 |
| 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 is a monocentric, randomized, double-blinded, controlled study designed to evaluate the sun protection efficacy (SPF) of a sunscreen product using a solar simulator. Eligible trial participants will provide informed consent and undergo screening, including ITA° value determination via spectrophotometry on the upper back. Based on the ITA°, a provisional MED (Minimal Erythema Dose – untreated) will be estimated using standardized UV dose increments. Test sites on the upper back will be marked and exposed to UV radiation with and without sunscreen products. Each test site includes six sub-sites, five of which receive UV exposure in 25% incremental doses, and one serves as a control. MEDu, MEDP, and MEDSTD values will be visually assessed 20 ± 4 hours post-exposure under controlled temperature conditions. The SPF will be determined based on erythema response at each site.
|