Ivermectin in the Treatment of Head Lice

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

812 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2004-10-31

Brief Summary

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The purpose of this study is to compare 2 single doses of ivermectin as tablets with 2 single applications of malathion 0.5% lotion (Days 1 and 8) in clearing head lice, in patients who have recently used standard head lice treatments without success.

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Detailed Description

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Head lice infestation occurs frequently, primarily in children 3 to 11 years of age. In recent years an increasing prevalence of lice infestation in schools, day care centres, and summer day camps is believed to be partly due to increasing lice resistance to currently available standard treatments for pediculosis (infestation with lice). There is a need for new effective backup treatments for this common condition of head lice infestation. This is a double-blind, randomized, parallel-group, study in several clinical centres comparing ivermectin as tablets to malathion 0.5% lotion in the treatment of head lice. All enrolled patients participate in the primary phase of the study up to the Day 15 evaluation. Patients who are still infested with lice at Day 15 (treatment failures) will enter an extension phase and be treated in a double-blind, fashion with the opposite treatment (ie ivermectin or malathion). The study hypothesis is that ivermectin will be more effective than malathion in clearing head lice infestation , as measured by the proportion of patients who are lice-free at Study Day 15.

Conditions

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Lice Infestations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ivermectin

ivermectin Stromectol®)

Group Type EXPERIMENTAL

ivermectin

Intervention Type DRUG

Two single doses of oral ivermectin 400 mcg/kg (Days 1 and 8) plus 2 single applications of placebo lotion

Malathion

malathion(Prioderm®)

Group Type ACTIVE_COMPARATOR

malathion

Intervention Type DRUG

Two single applications of malathion 0.5% lotion (Days 1 and 8) plus 2 single doses of placebo tablets

Interventions

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ivermectin

Two single doses of oral ivermectin 400 mcg/kg (Days 1 and 8) plus 2 single applications of placebo lotion

Intervention Type DRUG

malathion

Two single applications of malathion 0.5% lotion (Days 1 and 8) plus 2 single doses of placebo tablets

Intervention Type DRUG

Other Intervention Names

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Stromectol® Prioderm®

Eligibility Criteria

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Inclusion Criteria

* Head lice infestation confirmed by detection combing by study staff
* previous (within 6 weeks) use of a topical insecticide product
* minimum 15kg weight
* providing informed consent

Exclusion Criteria

* pregnant or nursing patients
* households with 7 or more infested patients
* households where there are other known infested household members not participating
* head lice treatment within 2 weeks of entry
* active scalp infection
* any difficulty with combing assessment
* patient from region endemic for certain parasitic worm diseases

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No