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
Overview
- Phase
- Phase 3
- Intervention
- ivermectin
- Conditions
- Lice Infestations
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Enrollment
- 812
- Locations
- 4
- Primary Endpoint
- Absence or presence of live head lice
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Ivermectin
ivermectin Stromectol®)
Intervention: ivermectin
Malathion
malathion(Prioderm®)
Intervention: malathion
Outcomes
Primary Outcomes
Absence or presence of live head lice
Time Frame: Study Day 15
Secondary Outcomes
- 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))