A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age
This is an open label, single center, single dose PK study of NatrOVA Creme Rinse (1%), an investigational treatment for head lice and nits, in normal, healthy infants.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1B Single Treatment, Pharmacokinetic and Tolerance Study of NatroVA Topical Creme (1%) i Pediatric Subjects 6 to 24 Months of Age|
- Safety: Frequency of Adverse events and scalp evaluations for irritation [ Time Frame: 4 hours ]
|Study Start Date:||December 2006|
|Study Completion Date:||January 2007|
There are millions of children and adults affected with head lice each year in the United States. It has become a major nuisance in school children resulting in many lost school days and frustrated parents. Lice and nit resistance to current OTC products is being widely reported. Compliance with product instructions is thought to be low. Therefore a safe and effective alternative to these products is desirable.
Spinosad (the active ingredient in NatrOVA) and its formulations have been approved as agricultural insecticides in the US, Canada and Australia, and has received provisional approval in the UK, Spain and several other European Union countries.
Spinosad is being formulated into a creme rinse product (NatrOVA) using excipients that are widely used and are "generally regarded as safe" (GRAS)
This study is intended to measure the absorption (or lack thereof) of Spinosad through the scalp of infants aged 6 to 24 months, as well as to observe any adverse events related to use of the study drug. A validated method for determining the levels of Spinosad in plasma will be utilized.