None listed
Conditions
Interventions
Intervention1: 143-015: Product will be in contact with skin for 24h under occlusion / semi occlusion as per BIS 4011: 2018 guidelines.
Intervention2: 143-014: Product will be in contact with skin for
Sponsors
ITC Life Sciences and Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Trial participants in age group 18 - 65 years (both the ages inclusive). 2. Healthy male & female trial participants with skin types as defined in the population details under appendix. 3. Trial participants with Fitzpatrick skin type III to V 4. Trial participants in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data. 5. Trial participant able to read, understand and sign an appropriate informed consent form indicating her willingness to participate. 6. Trial participants willing to give a voluntary written informed consent. 7. Trial participants willing to maintain the patch test in position for 24 hours. 8. Trial participant having not participated in a similar investigation in the past two weeks. 9. Trial participants willing to come for regular follow up visits. 10. Trial participants ready to follow instructions during the study period.
Exclusion criteria
Exclusion criteria: 1. Trial participants with infection, allergy on the tested area. 2. Trial participants with skin allergy, antecedents or atopic trial participants. 3. Athletes and trial participants with history of excessive sweating. 4. Trail participants with cutaneous disease which may influence the study result. 5. Trail participants on oral corticosteroid. 6. Trial participants participating in any other cosmetic or therapeutic trial. 7. Trial participants who are currently pregnant or lactating or planning to become pregnant in the period of study. 8. 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. 9. More than one trial participant selected/ participating from one family/ household. 10. Trial participants working with MSCR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of the study is to determine the potential irritation of the test formulation in different skin types in a Primary Irritation Patch TestTimepoint: 0 hr, 24 hr, 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactRadha S
MS Clinical Research Pvt. Ltd.
Outcome results
None listed