None listed
Conditions
Interventions
Intervention1: TSP 128-164 A: 40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre
Duration: 9 days for each subject
Intervention2: TSP 128-167A: 40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 4
Duration: 9 days for each subject
Intervention3: TSP 136-151B: 40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 4
Duration: 9 days for each subject
Intervention4: TSP-142-195: 40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40
Duration: 9 days for each subject
Intervention5: TSP-142-197: 40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40
Duration: 9 days for each subject
Intervention6: TSP-142-198: 40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40
Duration: 9 days for each subject
Intervention7: 125-18: 40 microlitre of investigational product with or without
Sponsors
ITC Life Sciences & Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects in age group 18 - 65 years (both the ages inclusive). 2. Healthy male & female subjects with skin types as defined in the population details under appendix. 3. Subjects with Fitzpatrick skin type III to V 4. Subjects 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. Subject able to read, understand and sign an appropriate informed consent form indicating her willingness to participate. 6. Subjects willing to give a voluntary written informed consent. 7. Subjects willing to maintain the patch test in position for 24 hours. 8. Subject having not participated in a similar investigation in the past two weeks. 9. Subjects willing to come for regular follow up visits. 10. Subjects ready to follow instructions during the study period
Exclusion criteria
Exclusion criteria: 1. Subjects with infection, allergy on the tested area. 2. Subjects with skin allergy, antecedents or atopic subjects. 3. Athletes and subjects with history of excessive sweating. 4. Subjects with cutaneous disease which may influence the study result. 5. Subjects on oral corticosteroid. 6. Subjects participating in any other cosmetic or therapeutic trial. 7. Subjects who are currently pregnant or lactating or planning to become pregnant in the period of study. 8. Subjects 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 subject selected or participating from one family or household. 10. Subjects 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 ContactDr Navya Annam
MS Clinical Research
Outcome results
None listed