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Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice

NCT ID: NCT00291057

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-12-31

Brief Summary

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In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population.

The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.

Detailed Description

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Conditions

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Lice Infestations

Keywords

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Pediculosis Head Lice

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

MALG

Group Type EXPERIMENTAL

MALG

Intervention Type DRUG

30 minute application

Interventions

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MALG

30 minute application

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed active head lice infestation
* Parent or guardian must be able to apply treatment

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

6 Months

Maximum Eligible Age

24 Months

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

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-0508

Identifier Type: -

Identifier Source: org_study_id