Conditions: Pediculosis
Keywords: Pediculosis capitis Head Lice
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 26
Healthy volunteers: no

Brief summary:
A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in pediatric subjects 6 months to 4 years of age with an active head lice infestation.

Detailed description:
A Postmarketing Requirement Protocol, multicenter, open-label study in pediatric subjects 6 months to 4 years of age with an active head lice infestation designed to determine the topical absorption and safety of Natroba (spinosad) Topical Suspension, 0.9% for a single, 10 minute treatment for spinosad (Spinosyn A and Spinosyn D) and benzyl alcohol.

Arms:
arm 1: Natroba (Spinosad) Topical Suspension, 0.9%

Interventions: intervention 1: spinosad
Intervention descriptions: intervention 1: A sufficient amount of Natroba Topical Suspension was applied to completely cover the scalp, worked out to the ends of the hair, and left in place for 10 minutes (±30 seconds), followed by a complete rinse and shampoo.

Protocol document: