NCT00545753

Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice

A Phase 3 Comparative Safety and Efficacy Study Between NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects >6 Months of Age or Older With Pediculosis Capitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 558 (actual)
• Sponsor: ParaPRO LLC · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (human head lice).

Detailed description

This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment.

Conditions

• Pediculosis

Interventions

Type	Name	Description
DRUG	Spinosad	10 minute topical application product, following by a complete rinse off.
DRUG	Spinosad	10 minute topical application followed by a complete rinse off, followed by a nit combing regimen
DRUG	Permethrin 1%	Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-03-01
• Completion: 2008-05-01
• First posted: 2007-10-17
• Last updated: 2012-10-11
• Results posted: 2012-10-11

Locations

6 sites across 1 country: United States