None listed
Conditions
Interventions
Intervention1: SBL Baby Care Soap: Take 0.04 ml or 0.04 g of the sample using a micropipette or weighing balance (as applicable) on the patch and apply the patch on the upper arm or back. The patches
Sponsors
SBL Private ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects in the age group 18 - 55 years (both the ages inclusive). 2. Healthy male and female subjects. 3. Subjects with Fitzpatrick skin type III to V 4. Subjects willing to give written informed consent. 5. Subjects willing to maintain the patch test in position for 24 hours. 6. Subject having not participated in a similar investigation in the past one month. 7. Subjects willing to come for regular follow-up visits. 8. Subjects ready to follow instructions during the study period.
Exclusion criteria
Exclusion criteria: 1. Infection, allergy on the tested area. 2. Skin allergy, antecedents or atopic subjects. 3. Athletes and subjects with history of excessive sweating. 4. Cutaneous disease which may influence the study result. 5. Subject has used topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated within 7 days of skin barrier assessment 6. Subjects participating in any other cosmetic or therapeutic study. 7. Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean Cumulative irritancy Index using Draize scale for scoring the treatment sites (Erythema and Oedema) during Induction phase 2. Skin sensitisation using ICDRG scale for scoring the treatment sites as per IS 4011:2018 during challenge phaseTimepoint: o to 37 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the adverse EventsTimepoint: 0 to 37 days | — |
Countries
India
Contacts
Public ContactMs Shilpi Sachdeva
Basavanagudi Clinic
Outcome results
None listed