None listed
Conditions
Interventions
Intervention1: Two test Products: Both the products (one product for one subject) will be applied in a quantity of 0.5 grams (approximately 2 pumps) twice daily for a duration of 14 days
Control Inter
Sponsors
ITC Limited ITC Life Sciences Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects aged 18-50 years old (both inclusive) 2. Occupationally be exposed to an excessively high concentration of air pollution (i.e. outdoor workers) 3. Having sensitive skin or normal skin (as evaluated by stinging test) 4. Have lived in this high air pollution area for at least the past 2 years OR they must have been occupationally exposed to this high air pollution for the past 2 years 5. Not be using fairness or antiaging or sunscreen creams/lotions 6. Free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face 7. Agree not to use any other product/treatment (eg: night cream) on their face during the study period (for male subjects shaving cream/foam/gel can be used for shaving purpose) 8. Agree not to carry out bleaching or any other procedures including facial etc. on face during the study period 9. Agree to remove all jewellery on/around face (e.g., necklace, earrings, nose ring) during VISIA imaging 10. Female subjects with child-bearing potential willing to undergo Urine Pregnancy Test on baseline visit and to use acceptable methods of contraception 11. Subject willing to provide written informed consent and is able to read, speak, write, and understand English or Hindi 12. Ready to follow instructions and study restrictions during the study period
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to any of the study products or constituents 2. Any significant skin pathology in the test area 3. Currently taking any medication including food supplements, which the Investigator believes may influence the interpretation of the data 4. Having chronic illness or had major surgery in the last year 5. Undergoing any treatment of any skin condition on their face/body 6. Allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else 7. Females in pregnancy (self-declared on screening visit and confirmed by UPT on baseline visit) or lactation at the beginning of the study or planned during the study 8. Participation in any other clinical trial up to 1 month prior to inclusion and during the study 9. Any topical or systemic treatment(s) such as NSAIDs, corticosteroids, retinoids, vitamins etc. that, in the investigatorââ?¬•s judgement, could interfere with the study treatments / assessments, taken 2 weeks prior to inclusion and / or planned during the study 10. Who have started, stopped or changed their hormonal treatment(s) (including contraceptive pill) in the previous one month prior to the study 11. Any history of allergy to NSAIDs, vitiligo, herpes, local infection & epilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of two topical test products in comparison with placebo on pollution-induced skin damages used over a period of 2 weeks, based on clinical, instrumental and subjective evaluations done at predetermined time pointsTimepoint: All the examination will be done Day 0, Day 7 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicableTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactRajat Gupta
CIDP Biotech India Pvt. Ltd
Outcome results
None listed