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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pediculosis Capitis, Head Lice

Intervention / Treatment
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* Drug: NatrOVA Creme Rinse - 1%
* Drug: NIX Creme Rinse - 1% permethrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediculosis Capitis, Head Lice