None listed
Conditions
Interventions
Intervention1: Baby Sunscreen (147-10/0326): Test products will be applied on the back of participants as per method detailed in BIS standards IS 17494 and IS 17660 guidelines
Control Intervention1: P
Sponsors
Mother Sparsh Baby Care Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Trial participants of both genders in age group 19 55 years (both the ages inclusive). 2.Test trial participants shall have an ITA value of at least 28 degrees by colorimetric methods and be untanned on the test area (i.e., back) 3.The average of the trial participants making up a test panel shall have an ITA between 28 degrees and 55 degrees. 4.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. 5.Trial participant willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study. 6.Trial participants willing to undergo water immersion testing, ensuring that the upper body or test sites remain submerged during immersion in a simulated swim test device. 7. Trial participants able to read, understand and sign on informed consent form indicating willingness to participate in the study. 8. 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. 9. Trial participants with no known abnormal response to sunlight.
Exclusion criteria
Exclusion criteria: 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 dysplastic 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 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 any prior UV exposure study within the last 6 weeks or more until the complete resolution of previous reaction on the test sites 16. Trial participants who are currently an employee of MSCR or the sponsor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the Sun Protection Factor and its water resistance properties of the test product in reference to the standard products in healthy adult trial participantsTimepoint: UV Exposure Day, Assessment Day (+24 hours), UV exposure Day, Assessment Day (+ 24 hours), UV exposure Day, Assessment Day (+ 24 hours) | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactSudhanthiran S
MS Clinical Research Pvt. Ltd
Outcome results
None listed