None listed
Conditions
Interventions
Intervention1: Day Cream – KB23: 70mg of the test product will be applied using PDP pipette. One time application.
Control Intervention1: Reference Standard
Sunscreen - P3
: 70mg of the test product
Sponsors
Unilever Industries Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant able to read, understand and sign on informed consent form indicating willingness to participate in the study. 2. Participants of either male or female gender in age group 18 – 55 years (both the ages inclusive). 3. Test participants shall have an ITA° value of at least 28° by colorimetric methods and be untanned on the test area (i.e., back) 4. The average of the participants making up a test panel shall have an ITA° between 41° and 55°. [When possible, there should be participants with ITA°s in each of the three ITA° bands, 28° to 40°, 41° to 55°, and >56°. Where this is not possible, there shall be at least three individuals in each of two of the three ITA° 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° greater than 5° from each other or the MEDu test area 6. 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. Participant willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study. 8. Participants willing to adhere and comply to the study protocol, procedure, restrictions and vising the study site for follow up visits at the specified date and time. 9. Participants with no known abnormal response to sunlight. 10. Participants willing and capable to follow the study rules and a fixed schedule.
Exclusion criteria
Exclusion criteria: • Participants showing COVID symptoms (cold, cough, fever, fatigue, headache, diarrhea, difficulty in breathing) • Participants who do not qualify on the thermal screening (body temperature higher than 37.5oC) or report to the study site without appropriate mask. • If any household member is positive (self-reported by the participants) within the 10 days prior to screening or during the study, then the participant will be withdrawn from the study. • Participants who disagree to follow the COVID safety protocol during the study. • Participants who have travelled outside the state (current interstate travel regulation) in the last 10 days and do not have negative RT-PCR report issued in last 72 hours 1. Participants with sun tan, blemishes, photo-toxicity reactions, cuts, abrasions, wounds, injuries, allergic reactions (in the tested area). 2. Participants allergic to cosmetic products such as moisturizers, creams and body lotion or anything else. 3. Skin allergy antecedents or atopic participants. 4. Participants having history of or having active photo dermatitis. 5. Participants on any known medication for photosensitization. (e.g., oral diabetic medications, Sulphur drugs, cancer chemotherapy) 6. Participants with cutaneous disease which may influence the study result. 7. Participants on oral corticosteroid in last 2 months. 8. Participants participating in any other cosmetic or therapeutic study. 9. Participants who are pregnant or lactating 10. Participants with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness. 11. Participants who have participated in a similar investigation in the past 8 weeks. 12. Participants who are currently an employee of MSCR or Unilever
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the sun protection factor of the investigational product in reference to standard product in healthy adult participants.Timepoint: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: NA | — |
Countries
India
Contacts
Public ContactSudhanthiran S
MS Clinical Research Pvt Ltd
Outcome results
None listed