Pediculosis Capitis (Head Lice) Clinical Trial
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
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00311779 -
A Dose Ranging Study of Different Strengths of Spinosad Topical Creme in Subjects With Pediculosis Capitis
|
Phase 2 |