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

Primary Purpose

Pediculosis Capitis, Head Lice

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

NatrOVA Creme Rinse - 1%

NIX Creme Rinse - 1% permethrin

About this trial

This is an interventional treatment trial for Pediculosis Capitis focused on measuring Pediculosis Capitis, Head Lice

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Concentrics Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

NatrOVA Creme Rinse - 1%

NIX Creme Rinse

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00857935

First Posted

March 5, 2009

Last Updated

March 6, 2009

Sponsor

ParaPRO LLC

1. Study Identification

Unique Protocol Identification Number

NCT00857935

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

ParaPRO LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediculosis Capitis, Head Lice

Keywords

Pediculosis Capitis, Head Lice

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

NatrOVA Creme Rinse - 1%

Arm Title

Arm Type

Active Comparator

Arm Description

NIX Creme Rinse

Intervention Type

Drug

Intervention Name(s)

NatrOVA Creme Rinse - 1%

Intervention Description

NatrOVA Creme Rinse, one or two, 10-minute topical treatments (7 days apart)

Intervention Type

Drug

Intervention Name(s)

NIX Creme Rinse - 1% permethrin

Intervention Description

NIX Creme Rinse: one or two, 10-minute topical treatments (7 days apart)

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Moore, MD

Organizational Affiliation

Concentrics Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Concentrics Research

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46240

Country

United States

12. IPD Sharing Statement

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

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