Clinical Trial: Ivermectin in the Treatment of Head Lice
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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 Summary: 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.
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Current Primary Outcome: Absence or presence of live head lice [ Time Frame: Study Day 15 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Absence or presence of live head lice at alternative Study Days. [ Time Frame: 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. [ Time Frame: throughout duration of the study (+ 30 days for spontaneously reported SAEs) ]
Original Secondary Outcome: Same as current
Information By: Johnson & Johnson Consumer and Personal Products Worldwide
Dates:
Date Received: January 8, 2009
Date Started: February 2004
Date Completion:
Last Updated: August 19, 2011
Last Verified: August 2011
