Ivermectin in the Treatment of Head Lice

Study Overview
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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.

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.

Official Title
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A Randomised, Double-Blind, Multicentre Study to Compare the Efficacy and Tolerability of Oral Ivermectin to Malathion 0.5% Lotion in the Treatment of Head Lice Infestation

Conditions
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Lice Infestations

Intervention / Treatment
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* Drug: ivermectin
* Drug: malathion


Participation Criteria
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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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivermectin<br>ivermectin Stromectol®) | Drug: ivermectin<br>* Two single doses of oral ivermectin 400 mcg/kg (Days 1 and 8) plus 2 single applications of placebo lotion<br>* Other names: Stromectol®;|
| Active Comparator: Malathion<br>malathion(Prioderm®) | Drug: malathion<br>* Two single applications of malathion 0.5% lotion (Days 1 and 8) plus 2 single doses of placebo tablets<br>* Other names: Prioderm®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence or presence of live head lice |  | Study Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence or presence of live head lice at alternative Study Days. |  | Study Days 2, 8, 22, 29 | 
| Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product. |  | throughout duration of the study (+ 30 days for spontaneously reported SAEs) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediculosis capitis, pediculus