None listed
Conditions
Interventions
Intervention1: The Body Shop SUN DEFENCE - Daily Face Moisturizer (FND35828): Test product will be applied at 2 mg per cm2 on upper back sites 35 cm2 (7 by 5 centimeters) each with participants in pro
Sponsors
QUEST RETAIL PRIVATE LIMITED
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 18 ? 55 years (both the ages inclusive). 3. Participants selected for the SPF test must have an Individual Typology Angle (ITA) value of at least 28 degrees as measured by colorimetric methods and should have untanned skin on the test area (i.e., back) 4. The average ITA value of participants in the test panel must fall between 41 and 55 degrees. If possible, participants should be selected from all three ITA bands: 28 to 40 degrees, 41 to 55 degrees, and greater than 56 degrees. If not feasible, there must be at least three participants from any two of these three bands 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. Trial 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. Trial participant willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study. 8. Trial participants willing to adhere to the study procedure, restrictions and vising the study site for follow up visits at the specified date and time. 9. Trial participants willing and capable to follow the study rules and a fixed schedule. 10. 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, 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 dysplas-tic 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 (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. 16. Trial participants who are currently an employee of MSCR or the sponsor 17. Trial Participants who have used self-tanning products on the back area in the previous 1 month prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the sun protection factor of the investigational products in reference to standard product in healthy adult trial participants.Timepoint: 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