Ivermectin in the Treatment of Head Lice
Information source: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lice Infestations
Intervention: ivermectin (Drug); malathion (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Consumer and Personal Products Worldwide Official(s) and/or principal investigator(s): Jerry Cottrell, Study Director, Affiliation: J&J Consumer and Personal Products Worldwide
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Absence or presence of live head lice
Secondary outcome: Absence or presence of live head lice at alternative Study Days.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.
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.
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Chaim Sheba Medical Centre, Tel Hashomer 52621, Israel
Synexus Clinical Research Centre, Reading, Berks RG2 7AG, United Kingdom
Shandon Clinic, Cork, Co. Cork, Ireland
Hopital Avicenne, Bobigny, Paris 93009, France
Additional Information
Starting date: February 2004
Last updated: August 19, 2011
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