Odomos Oil (NN Diethylbenzamide 12% w/v) is oil-based medication used as a mosquito repellent in healthy infants.
Phase 4
- Registration Number
- CTRI/2023/11/059772
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Healthy Male or female infants aged 4-11 months
Exclusion Criteria
? Aggravated history of allergies.
? Any Pre-existing diseased skin condition
? Conditions that, in the Investigator’s opinion, are contraindications for using NN
Diethylbenzamide. ? Acute viral and bacterial infections at the moment of study inclusion or within 2 weeks
before study inclusion;
? Participation in other clinical studies of experimental IP at the present time or within last 3
months before study inclusion;
? Parents lack of readiness to collaborate;
? Refuse to carefully adhere to Investigator’s prescriptions and indications according to the
protocol.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate safety of NN Diethylbenzamide 12% w/v body oil in infants aged 4 to 11 monthsTimepoint: 14 days
- Secondary Outcome Measures
Name Time Method 1. Time to first allergic reaction, skin irritation, swelling, inflammation, rashes, redness at oil <br/ ><br>application site. <br/ ><br>2. Global assessment by Investigator & parents ofTimepoint: 14 days