Ivermectin in the Treatment of Head Lice

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

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.

Study Overview

• Status: Completed
• Conditions: Lice Infestations
• Intervention / Treatment: Drug: ivermectin; Drug: malathion

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.

• Study Type: Interventional
• Enrollment (Actual): 812
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris
    • Bobigny, Paris, France, 93009
      • Hopital Avicenne
• Ireland
  • Co. Cork
    • Cork, Co. Cork, Ireland
      • Shandon Clinic
• Israel
  • Tel Hashomer, Israel, 52621
    • Chaim Sheba Medical Centre
• United Kingdom
  • Berks
    • Reading, Berks, United Kingdom, RG2 7AG
      • Synexus Clinical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ivermectin; ivermectin Stromectol®)	Drug: ivermectin; Two single doses of oral ivermectin 400 mcg/kg (Days 1 and 8) plus 2 single applications of placebo lotion; Other Names: Stromectol®
Active Comparator: Malathion; malathion(Prioderm®)	Drug: malathion; Two single applications of malathion 0.5% lotion (Days 1 and 8) plus 2 single doses of placebo tablets; Other Names: Prioderm®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absence or presence of live head lice	Study Day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Investigators: Study Director: Jerry Cottrell, J&J Consumer and Personal Products Worldwide

Publications and helpful links

General Publications

• 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. Erratum In: N Engl J Med. 2010 Apr 29;362(17):1647.

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): September 1, 2004
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: January 8, 2009
• First Submitted That Met QC Criteria: January 8, 2009
• First Posted (Estimate): January 9, 2009

Study Record Updates

• Last Update Posted (Estimate): August 22, 2011
• Last Update Submitted That Met QC Criteria: August 19, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: pediculosis capitis; pediculus
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations; Parasitic Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Cholinergic Agents; Enzyme Inhibitors; Antiparasitic Agents; Cholinesterase Inhibitors; Ivermectin; Malathion
• Other Study ID Numbers: 075-00