Clinical trial NCT00819520: Ivermectin in the Treatment of Head Lice
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lice Infestations
Keywords: pediculosis capitis
pediculus
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2009-01-09
Enrollment: 812
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Absence or presence of live head lice
timeFrame: Study Day 15
Secondary outcomes:
measure: Absence or presence of live head lice at alternative Study Days.
timeFrame: Study Days 2, 8, 22, 29
measure: 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.
timeFrame: throughout duration of the study (+ 30 days for spontaneously reported SAEs)
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hopital Avicenne
state: Paris
city: Cork
country: Ireland
facility: Shandon Clinic
state: Co. Cork
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Centre
city: Reading
country: United Kingdom
facility: Synexus Clinical Research Centre
state: Berks
Study officials:
affiliation: J&J Consumer and Personal Products Worldwide
name: Jerry Cottrell
role: STUDY_DIRECTOR
References:
citation: Chosidow O, Giraudeau B, Cottrell J, Izri A, Hofmann R, Mann SG, Burgess I. Oral ivermectin versus malathion lotion for difficult-to-treat head lice. N Engl J Med. 2010 Mar 11;362(10):896-905. doi: 10.1056/NEJMoa0905471.