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NCT00545753 · ClinicalTrials.gov registry record · Phase 3

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 study, sponsored by ParaPRO.

Completed
Registry status
Phase 3
Development phase
558
Enrollment target

NCT00545753: Completed Phase 3 study, sponsored by ParaPRO.

NCT00545753 is a Phase 3 study that has completed, run by ParaPRO. The registered enrollment target is 558 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00545753, a Phase 3 study, has completed, sponsored by ParaPRO.

COMPLETED
Registry status
Phase 3
Development phase
558 participants
Enrollment target

Study 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).

Primary Outcome

The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).

Interventions

  • DRUG Permethrin 1%
  • DRUG Spinosad

Trial Details

FieldValue
Enrollment Target 558 participants
Start Date 2007-09
Est. Completion 2008-05
Phase Phase 3
ParaPRO

11 total trials

What the finished NCT00545753 record still lists

NCT00545753 is an interventional study that assigns participants to a tested intervention. The registered 558 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).

The record links to 0 conditions, and to 2 interventions - of which Permethrin 1% is the first listed.

NCT00545753 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00545753 about?

NCT00545753 is a clinical study titled "Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice". 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).

What is the current status of trial NCT00545753?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 558 participants. The study started on 2007-09. Estimated completion is 2008-05.

What interventions are being tested in trial NCT00545753?

The interventions under investigation include: Permethrin 1% (DRUG), Spinosad (DRUG).

Who is sponsoring clinical trial NCT00545753?

This trial is sponsored by ParaPRO, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00545753's enrollment target sits among peer trials

558 673rd of 2000 higher than 1,327 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00545753, the US trial registry maintained by the National Library of Medicine. NCT00545753 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.