None listed
Conditions
Interventions
Intervention1: 1. MS18: Investigational product without dilution will be applied on the back side of the participant. Dose- 40 Microliter
Frequency- once during the study period
Route of administration- Topical.
Intervention2: 2. DD21: Investigational product without dilution will be applied on the back side of the participant. Dose- 40 Microliter
Route of administration- Topical.
Intervention3: 3. NN28: Investigational product with dilution will be applied on the back side of the participant. Dose- 40 Microliter
Route of administration- Topical.
Control Intervention1: 4. PC-1: comparator agent at defined concentration will be applied on the back side of the participant. Dose- 40 Microliter
Route of administration- Topical.
Control Intervention2: 5. PC-2: comparator agent at defined concentration will be applied on the back side of the participant. Dose- 40 Microliter
Route of administration- Topical.
Control Intervention3: 6. NC: comparator agent at defined concentration will be applied on the back side of the participant. Dose- 40 Microliter
Sponsors
Unilever Industries Pvt Ltd
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. 3. 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. 4. Participants of any skin type providing the skin pigmentation will allow discernment of erythema 5. Participants 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 in position for 24 hours. 8. Participants 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, psoriasis and/or active atopic dermatitis/eczema on the tested area. 2. Athletes and participants with history of excessive sweating. 3. Participants with cutaneous disease which may influence the study result. 4. Participants on oral corticosteroid. 5. Participants participating in any other cosmetic or therapeutic trial or have participated in a similar investigation in the past two weeks. 6. Participants who are currently pregnant or lactating or planning to become pregnant in the period of study. 7. Participants with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness. 8. More than one participant selected/participating from one family/household. 9. Participants 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