Ivermectin in the Treatment of Head Lice

Lice Infestations Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819520
• Other study ID #: 075-00
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2009
• Last updated: August 19, 2011
• Start date: February 2004
• Est. completion date: October 2004

Study information

• Verified date: August 2011
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéIreland: Irish Medicines BoardUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 812
• Est. completion date: October 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lice Infestations
• Parasitic Diseases

Intervention

Drug:
• ivermectin
Two single doses of oral ivermectin 400 mcg/kg (Days 1 and 8) plus 2 single applications of placebo lotion
• malathion
Two single applications of malathion 0.5% lotion (Days 1 and 8) plus 2 single doses of placebo tablets

Locations

Country	Name	City	State
France	Hopital Avicenne	Bobigny	Paris
Ireland	Shandon Clinic	Cork	Co. Cork
Israel	Chaim Sheba Medical Centre	Tel Hashomer
United Kingdom	Synexus Clinical Research Centre	Reading	Berks

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer and Personal Products Worldwide

Countries where clinical trial is conducted

France,  Ireland,  Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence or presence of live head lice		Study Day 15	No
Secondary	Absence or presence of live head lice at alternative Study Days.		Study Days 2, 8, 22, 29	No
Secondary	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)	No