None listed
Conditions
Interventions
Intervention1: sunscreen cream (PA++++): 2.00 ± 0.05 mg/cm2 of the test product will be dispensed using a finger cot. Then spread over the whole test site, first with circular movements to gather the
Sponsors
ITC Life Sciences & Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject able to read, understand and sign on informed consent form indicating willingness to participate in the study. 2. Subjects of both genders in age group 19 – 55 years (both the ages inclusive). 3. Test subjects 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 subjects making up a test panel shall have an ITA between 41 and 55. [When possible, there should be subjects with ITAs in each of the three ITA bands, 28 to 40, 41 to 55, and more than 56. Where this is not possible, there shall be at least three individuals in at least 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. Subjects 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. Subjects willing to undergo water immersion testing, ensuring that the upper body or test sites remain submerged during a simulated swim test device. 8. Subject willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study. 9. Subjects willing to adhere to the study procedure, restrictions and visiting the study site for follow up visits at the specified date and time. 10. Subjects with no known abnormal response to sunlight. 11. Subjects willing and capable to follow the study rules and a fixed schedule.
Exclusion criteria
Exclusion criteria: 1. Subjects with sun tan, blemishes, photo-toxicity reactions, cuts, abrasions, wounds, injuries, allergic reactions (in the tested area). 2. Subjects allergic to cosmetic products such as moisturizers, creams and body lotion or anything else. 3. Skin allergy antecedents or atopic subjects. 4. Subjects having history of or having active photo dermatitis. 5. Subjects on any known medication for photosensitization. (eg. oral diabetic medications, Sulphur drugs, cancer chemotherapy) 6. Subjects with cutaneous disease which may influence the study result. 7. Subjects on oral corticosteroid in last 2 months. 8. Subjects participating in any other cosmetic or therapeutic study. 9. Subjects who are pregnant or lactating 10. Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness. 11. People suffering from CVD or hypertension or hypotension or are prone to develop hypothermia and subjects suffering from arthritis (all conditions are self-declared). 12. Subjects who have participated in a similar investigation in the past 8 weeks. 13. Subjects who are currently an employee of MSCR or the sponsor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the sun protection factor and water resistance of test sunscreen products in adult subjects.Timepoint: Approximately 6 days for each subject | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Mukta Sachdev
MS Clinical Research Pvt. Ltd
Outcome results
None listed