Ivermectin in the Treatment of Head Lice

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00819520

Enrollment

812

Registered

2009-01-09

Start date

2004-02-29

Completion date

2004-10-31

Last updated

2011-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lice Infestations

Keywords

pediculosis capitis, pediculus

Brief summary

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

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.

Interventions

DRUGivermectin

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

DRUGmalathion

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Absence or presence of live head lice	Study Day 15

Secondary

Measure	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)

Countries

France, Ireland, Israel, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026