A Safety and Efficacy Pilot Study Comparing NatrOVA Creme... | NCT00857935

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

NCT00857935

Sponsor

ParaPRO LLC

Status

Completed

Last Update Posted

Mar 9, 2009Estimated

Enrollment

24Actual

Phase

Phase 2

Conditions

Pediculosis Capitis
Head Lice

Interventions

NatrOVA Creme Rinse - 1%
NIX Creme Rinse - 1% permethrin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Concentrics 71007

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Mar 5, 2009

First Submission Date that Met QC Criteria

Mar 6, 2009

First Posted Date

Mar 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2009

Last Update Posted Date

Mar 9, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	NatrOVA Creme Rinse - 1%	Drug: NatrOVA Creme Rinse - 1%
2	Active Comparator	NIX Creme Rinse	Drug: NIX Creme Rinse - 1% permethrin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NatrOVA Creme Rinse - 1%	Drug	NatrOVA Creme Rinse, one or two, 10-minute topical treatments (7 days apart)	1

Outcomes Module

Primary Outcomes

Measure	Description	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.		14 days after last treatment

Secondary Outcomes

Measure	Description	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.		14 days after last treatment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010647	Phenyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D010636	Phenols
D001555