None listed
Conditions
Interventions
Intervention1: Baby Sunscreen (147-10/0326): Test product will be applied on the back of participants as per BIS standards IS 17492 2021 guidelines
Control Intervention1: Reference standard (S1 or S2)
Sponsors
Mother Sparsh Baby Care Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 19 55 years (both the ages inclusive). 3. Trial participants with a colorimetric ITA value in the range of 20 degrees to 41 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 colour and no sunburn (erythema), 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 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 adhere to the study procedure, restrictions and visiting the study site for follow up visits at the specified date and time. 7. Trial participant in good physical and mental health with, in the opinion of the investigator or medically qualified person
Exclusion criteria
Exclusion criteria: 1. Trial participants with sun tan, blemishes, photo-toxicity reactions, cuts, abrasions, wounds, injuries, allergic reactions (in the tested area). 2. Trial participants with known 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 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 UVA Protection factor of the test product in reference to standard product in healthy adult trial participants.Timepoint: Day 1, Day 2, Day 3, Day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactSudhanthiran S
MS Clinical Research Pvt. Ltd
Outcome results
None listed