CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 558 enrolled
Drug / intervention
Spinosad +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00545753
NCT00545753Phase 3Completed

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

ParaPRO LLC·interventional·Posted Oct 17, 2007·Updated Oct 11, 2012

In Brief

A Phase 3 clinical trial evaluating Spinosad and Permethrin 1% for Pediculosis. Completed, enrolled 558 participants across 6 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediculosis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 17, 2007
Enrollment StartSep 1, 2007
Primary CompletionMar 1, 2008
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.7 years ago

Interventions

Spinosaddrug

10 minute topical application product, following by a complete rinse off.

Spinosaddrug

10 minute topical application followed by a complete rinse off, followed by a nit combing regimen

Permethrin 1%drug

Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen