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
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 18 – 55 years (both the ages inclusive). 3. Subjects with a colorimetric ITA value in the range of 20-41o, providing persistent pigmentation darkening to the UVA dose. (Phototype of the subject will be recorded) 4. Subjects 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. 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. 6. Subject willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study. 7. Subjects willing to adhere to the study procedure, restrictions and visit the study site for follow up visits at the specified date and time. 8. Subjects with no known abnormal response to sunlight. 9. 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. Subjects who have participated in a similar investigation in the past 8 weeks. 12. Subjects who are currently an employee of MSCR or the sponsor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the UVA protection factor of the investigational product in adult subjects.Timepoint: Approximately for 06 days for each subject. | — |
Secondary
| Measure | Time frame |
|---|---|
| noneTimepoint: none | — |
Countries
India
Contacts
Public ContactDr Mukta Sachdev
MS Clinical Research Pvt.Ltd
Outcome results
None listed