A clinical trial to study whether the odomos oil is safe to use in healthy childrens.
- Registration Number
- CTRI/2010/091/001309
- Lead Sponsor
- DABUR INDIA LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
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
?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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the dermatological safety of Odomos Oil on skin of healthy childrens. <br/ ><br>Timepoint: evaluations will be done on Day0,2,4,7
- Secondary Outcome Measures
Name Time Method To evaluate the potential allergenicity of Odomos Oil on skin of healthy childrens.Timepoint: Evaluations done on Day 0,2,4,7