None listed
Conditions
Interventions
Intervention1: 18-076 A: Product will be in contact with skin for 24h under occlusion/semi-occlusion as per BIS 4011:2018 guidelines
Intervention2: 19-053 A: Product will be in contact with skin for 2
Sponsors
ITC Life Sciences and Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants in age group 18 - 65 years (both the ages inclusive). 2. Healthy male & female participants with skin types as defined in the population details under appendix. 3. Participants with Fitzpatrick skin type III to V 4. 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. Participant able to read, understand and sign an appropriate informed consent form indicating her willingness to participate. 6. Participants willing to give a voluntary written informed consent. 7. Participants willing to maintain the patch test in position for 24 hours. 8. Participant having not participated in a similar investigation in the past two weeks. 9. Participants willing to come for regular follow up visits. 10. Participants ready to follow instructions during the study period.
Exclusion criteria
Exclusion criteria: 1. Participants with infection, allergy on the tested area. 2. Participants with skin allergy, antecedents or atopic participants. 3. Athletes and participants with history of excessive sweating. 4. Participants with cutaneous disease which may influence the study result. 5. Participants on oral corticosteroid. 6. Participants participating in any other cosmetic or therapeutic trial. 7. Participants who are currently pregnant or lactating or planning to become pregnant in the period of study. 8. 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 Participant selected/ participating from one family/ household. 10. 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 varied skin types in a Primary Irritation Patch Test.Timepoint: Baseline, 0-hour, 24-hour and Day7 | — |
Secondary
| Measure | Time frame |
|---|---|
| nilTimepoint: nil | — |
Countries
India
Contacts
Public ContactRadha S
M S CLINICAL RESEARCH PVT.LTD
Outcome results
None listed