Ivermectin in the Treatment of Head Lice

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 3

Conditions

Lice Infestations

Treatments

Drug: malathion

Drug: ivermectin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00819520

075-00

Details and patient eligibility

About

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.

Full 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.

Enrollment

812 patients

Sex

All

Ages

2+ years old

Volunteers

No 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