Pediculosis Capitis (Head Lice) Clinical Trial
Official title:
Phase 2 Study of Efficacy and Safety of Different Strengths of Spinosad Topical Creme Rinse (0%, 0.5% or 1.0%) in Subjects 2 Years of Age or Older With Pediculosis Capitis - A Dose Ranging Study
The primary objective of the study is to determine the safety and efficacy of different strengths of Spinosad topical creme, as compared to a vehicle control, in subjects who have been infested with at least a mild case of Pediculosis capitis (head lice).
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 (ova) resistance to current OTC products has been
reported. Compliance with product instructions is thought to be low. Therefore a safe and
effective alternative to these products is desirable.
Spinosad and its formulations have been approved by the Environmental Protection Agency as
crop protection products 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 as a creme rinse using excipients that are widely used and are
"generally regarded as safe" (GRAS).
This study is intended to show the safety and efficacy of Spinosad 0.5% and 1.0%, as
compared to the vehicle control in subjects 2 years of age and older with at least a mild
infestation of pediculosis capitis.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00410709 -
A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age
|
Phase 1 |