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Pyrethroid

A - NatrOVA 1% - no nit combing for Head Lice

Phase 3
Waitlist Available
Research Sponsored by ParaPRO LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

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).

Eligible Conditions
  • Head Lice

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice
Secondary study objectives
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.

Side effects data

From 2008 Phase 3 trial • 480 Patients • NCT00545168
7%
Application site erythema
1%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
C - NIX
A/B - NatrOVA 1% - With/Without Nit Combing

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: B - NatrOVA 1% - nit combing requiredExperimental Treatment1 Intervention
NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
Group II: A - NatrOVA 1% - no nit combingExperimental Treatment1 Intervention
NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
Group III: C - NIXActive Control1 Intervention
NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinosad
FDA approved

Find a Location

Who is running the clinical trial?

ParaPRO LLCLead Sponsor
11 Previous Clinical Trials
1,415 Total Patients Enrolled
Bill Miller, MDStudy DirectorConcentrics Research
1 Previous Clinical Trials
480 Total Patients Enrolled
~31 spots leftby Nov 2025
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