None listed
Conditions
Interventions
Intervention1: Odomos Oil: Patch applied on upper back of children and retained for 48 hours
Control Intervention1: Vaseline & Liquid paraffin: Patch applied on upper back of children and retained for
Sponsors
DABUR INDIA LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: ? Healthy children volunteers ? Legally acceptable representatives ready to sign the informed consent ? Subjects willing to maintain the applied patch in position for 48 hours ? Subjects of age group 2 - 12 years ? Subject has not participated in a similar investigation in the past four weeks. ? All willing parents and subjects will sign voluntarily in the parent informed consent and assent document and come for regular follow up. ? Subjects ready to follow instructions during the study period.
Exclusion criteria
Exclusion criteria: Exclusion Criteria ? Infection, allergy on the tested area ? Skin allergy antecedents or atopic subjects ? Hyper sensitivity to any component of the tested products ? Athletes and subjects with history of excessive sweating ? Cutaneous disease which may influence the study result ? Chronic illness which may influence the cutaneous state. ? Subjects on oral corticosteroid with dose >10mg/day ? Subject in an exclusion period or participating in any other cosmetic or therapeutic trial. ? Any underlying medical illness including diabetes, liver disease, HIV, or any other serious medical illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the dermatological safety of Odomos Oil on skin of healthy childrens. Timepoint: evaluations will be done on Day0,2,4,7 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the potential allergenicity of Odomos Oil on skin of healthy childrens.Timepoint: Evaluations done on Day 0,2,4,7 | — |
Countries
India
Contacts
Public ContactMr V V Raghavan
Dabur India Limited
Outcome results
None listed