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

March 6, 2009 updated by: ParaPRO LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46240
        • Concentrics Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, 6 months of age or older
  • Subject must have a head lice infestation present at baseline
  • Subject/caregiver must read English or Spanish at a 7th grade level
  • Subject must have an appropriately signed Informed Consent agreement
  • Other members of the household with a lice infestation must be willing to be enrolled in the study or treat their infestations with a standard treatment
  • Subject agreement to not use any other form of lice treatment during the course of the study
  • Subject agreement to not cut or chemically treat their hair in the period between baseline and final, post-treatment visits

Exclusion Criteria:

  • Individuals with a history of irritation or sensitivity to pediculicides or hair care products
  • Individuals with any visible skin/scalp condition at the treatment site that could interfere with the evaluation
  • Individuals previously treated with a pediculicide or any other head lice treatment product within 48 hours prior to enrollment
  • Individuals receiving systemic or topical drugs that may interfere with the study results
  • Individuals who have participated in a clinical trial within 30 days of enrollment
  • Individuals with family members who are infested with lice but are unwilling or unable to enroll in the study or to use the standard course of lice treatment
  • Females who are pregnant or nursing
  • Sexually-active females not using effective contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
NatrOVA Creme Rinse - 1%
Drug: NatrOVA Creme Rinse - 1%
NatrOVA Creme Rinse, one or two, 10-minute topical treatments (7 days apart)
Active Comparator: 2
NIX Creme Rinse
Drug: NIX Creme Rinse - 1% permethrin
NIX Creme Rinse: one or two, 10-minute topical treatments (7 days apart)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of NatrOVA Creme Rinse-1% versus NIX Creme rinse, based on the presence or absence of live lice 14 days after the final treatment.
Time Frame: 14 days after last treatment
14 days after last treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety comparison between NatrOVA Creme Rinse-1% and NIX Creme Rinse, based on the occurrence of adverse events and any increase of scalp and/or ocular irritation, post-treatment.
Time Frame: 14 days after last treatment
14 days after last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ParaPRO LLC

Investigators

  • Principal Investigator: Mark Moore, MD, Concentrics Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 6, 2009

First Posted (Estimate)

March 9, 2009

Study Record Updates

Last Update Posted (Estimate)

March 9, 2009

Last Update Submitted That Met QC Criteria

March 6, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPN-203-07
  • Concentrics 71007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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