At a glance
ClinicalIndex Comparison RecordPhase 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.
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
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
Enrollment StartSep 2007
First PostedOct 2007
Primary CompletionMar 2008
Study CompletionMay 2008
TodayJul 2026
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