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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

403 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-03-31

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.

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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.

Conditions

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Pediculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Malathion Gel

Malathion gel 0.5% 30 minute application

Group Type EXPERIMENTAL

Malathion gel 0.5%

Intervention Type DRUG

Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.

Nix Crème Rinse

Nix Crème Rinse applied to scalp for 10 minutes

Group Type ACTIVE_COMPARATOR

Permethrin 1% rinse (Nix Crème)

Intervention Type DRUG

Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.

Interventions

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Malathion gel 0.5%

Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.

Intervention Type DRUG

Permethrin 1% rinse (Nix Crème)

Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.

Intervention Type DRUG

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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No