Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

Study Overview
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Brief Summary
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In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.

Detailed Description
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This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.

Official Title
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A Multi-Center Phase III Study to Evaluate Malathion Gel 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis

Conditions
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Pediculosis

Intervention / Treatment
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* Drug: Malathion gel 0.5%
* Drug: Permethrin 1% rinse (Nix Crème)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed active head lice infestation Exclusion Criteria: Allergy to pediculicides or hair care products Scalp conditions other than head lice Previous head lice treatment within the past 4 weeks Current antibiotic treatment

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Malathion Gel<br>Malathion gel 0.5% 30 minute application | Drug: Malathion gel 0.5%<br>* Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.<br>|
| Active Comparator: Nix Crème Rinse<br>Nix Crème Rinse applied to scalp for 10 minutes | Drug: Permethrin 1% rinse (Nix Crème)<br>* Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF) | The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7) Treatment Success in the Efficacy ITT (LOCF) index subjects: 150 from 403 randomized (the youngest subject in the household that met the index case criteria (having nits and at least 3 live lice)) | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF). | The secondary efficacy variable was the proportion of subjects who were considered a Treatment Success 14 days after their first treatment. Treatment Success in the Efficacy ITT (LOCF) | 3 weeks | 

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