None listed
Conditions
Interventions
Intervention1: 1. Balm (TLS2324006PR01026): 40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre
Frequency- once during the study period
Route of administration- Topical
Duration: 9 days for each subject
Control Intervention1: 2. Negative control (0.9N Saline): 40 microlitre of Negative control (0.9N Saline) will be applied on the back side of the subject along with t
Duration: 9 days for each subject
Control Intervention2: 3. Positive control (1% SLS): 40 microlitre of Positive control (1% SLS) will be applied on the back side of the subject along with the test pr
Sponsors
Transformative Learning Solutions Pvt Ltd
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. 3. 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. 4. Subject able to read, understand and sign an appropriate informed consent form indicating her willingness to participate. 5. Subjects willing to give a voluntary written informed consent. 6. Subjects willing to maintain the patch test in position for 24 hours. 7. Subject having not participated in a similar investigation in the past two weeks. 8. Subjects willing to come for regular follow up visits. 9. 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/participating from one family/household. 10. Subjects working with MSCR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the potential irritation of the test formulation on topical application in skin type human volunteers under controlled patch study conditions in a PIPT test.Timepoint: Approximately 9 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: NA | — |
Countries
India
Contacts
Public ContactRadha S
MS Clinical Research Pvt Ltd
Outcome results
None listed