NCT00857935

A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse

A Pilot Study to Test the Operational Elements of an Actual Use Study Designed to Compare the Safety and Efficacy of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months of Age or Older With Pediculosis Capitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: ParaPRO LLC · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis

Detailed description

A Phase 2b, randomized, single-site, investigator/evaluator blind, two-arm, parallel-group pilot study that tested the operational elements of an "Actual Use" study designed to evaluate the safety and efficacy of a 10-minute treatment and no-nit combing regimen of NatrOVA Creme Rinse 1% versus NIX Creme Rinse in subjects with at least a mild case of head lice.

Conditions

• Pediculosis Capitis
• Head Lice

Interventions

Type	Name	Description
DRUG	NatrOVA Creme Rinse - 1%	NatrOVA Creme Rinse, one or two, 10-minute topical treatments (7 days apart)
DRUG	NIX Creme Rinse - 1% permethrin	NIX Creme Rinse: one or two, 10-minute topical treatments (7 days apart)

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2009-03-09
• Last updated: 2009-03-09

Locations

1 site across 1 country: United States