A clinical trial to evaluate the dermatological safety and potential allergenicity of Odomos Oil and its vehicle on skin of healthy children.
- Registration Number
- CTRI/2010/091/002962
- Lead Sponsor
- DABUR INDIA LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
?Healthy children
?Subjects age group 2 - 12 year.
?Parent/Legally acceptable representatives ready to sign the informed consent.
?Subject willing to give the consent (if applicable)
?Subjects ready to follow instructions during the study period.
?Subjects willing to come for regular follow up.
?Infection, allergy on the exposed area, that is, upper and lower limbs.
?Skin allergy antecedents or atopic subjects
?Hyper sensitivity to any component of the tested products
?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 or history of HIV, or any other serious medical illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to evaluate the dermatological safety and potential allergenicity of Odomos Oil and its vehicle on skin of healthy children aged 2 to 12 years divided into 3 subsets of age groups (2-5 completed years, 6-8 completed years and 9-12 completed years).Timepoint: Approximately 30 days for each subject
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI