None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Healthy Male or female infants aged 4-11 months
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate safety of NN Diethylbenzamide 12% w/v body oil in infants aged 4 to 11 monthsTimepoint: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first allergic reaction, skin irritation, swelling, inflammation, rashes, redness at oil application site. 2. Global assessment by Investigator & parents ofTimepoint: 14 days | — |
Countries
India
Contacts
Excel Hospital