NCT00311779

A Dose Ranging Study of Different Strengths of Spinosad Topical Creme in Subjects With Pediculosis Capitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: ParaPRO LLC · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Pediculosis Capitis (Head Lice)

Interventions

Type	Name	Description
DRUG	Spinosad Creme Rinse

Timeline

• Start date: 2006-03-01
• Completion: 2006-07-01
• First posted: 2006-04-06
• Last updated: 2006-07-12

Locations

3 sites across 1 country: United States