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Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice

NCT ID: NCT00244439

Last Updated: 2013-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-12-31

Brief Summary

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Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.

Detailed Description

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Conditions

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Lice Infestations

Keywords

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Head Lice Pediculosis capitis

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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1

MALG

Group Type EXPERIMENTAL

MALG

Intervention Type DRUG

30 minute application

2

Ovide

Group Type ACTIVE_COMPARATOR

Ovide (malathion) lotion 0.05%

Intervention Type DRUG

8-12 hour application

3

Permethrin 1%

Group Type ACTIVE_COMPARATOR

Permethrin 1%

Intervention Type DRUG

10 minute application

Interventions

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MALG

30 minute application

Intervention Type DRUG

Ovide (malathion) lotion 0.05%

8-12 hour application

Intervention Type DRUG

Permethrin 1%

10 minute application

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed active head lice infestation
* Patient, parent or guardian must be able to apply the treatment
* Entire household must be screened
* All infested persons must agree to participate

Exclusion Criteria

* Allergy to pediculicides, hair care products or chrysanthemums
* Scalp conditions other than head lice
* Previous head lice treatment within the past 4 weeks
* Female patients who are pregnant or nursing
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Taro Pharmaceuticals USA

Locations

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Investigator Site

Scottsdale, Arizona, United States

Site Status

Investigator Site

Miami, Florida, United States

Site Status

Investigator Site

St. Petersburg, Florida, United States

Site Status

Investigator Site

West Palm Beach, Florida, United States

Site Status

Investigator Site

New York, New York, United States

Site Status

Investigator Site

Miamiville, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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MALG-0506

Identifier Type: -

Identifier Source: org_study_id