Ivermectin in the Treatment of Head Lice

• ClinicalTrials.gov Identifier: NCT00819520
• Recruitment Status: Completed
• First Posted: January 9, 2009
• Last Update Posted: August 22, 2011
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lice Infestations	Drug: ivermectin; Drug: malathion	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 812 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: February 2004
• Actual Primary Completion Date: September 2004
• Actual Study Completion Date: October 2004

Arms and Interventions

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 Name: 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 Name: Prioderm®

Outcome Measures

Primary Outcome Measures :

1. Absence or presence of live head lice [ Time Frame: Study Day 15 ]

Secondary Outcome Measures :

1. Absence or presence of live head lice at alternative Study Days. [ Time Frame: Study Days 2, 8, 22, 29 ]
2. 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) ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

France

Hopital Avicenne

Bobigny, Paris, France, 93009

Ireland

Shandon Clinic

Cork, Co. Cork, Ireland

Israel

Chaim Sheba Medical Centre

Tel Hashomer, Israel, 52621

United Kingdom

Synexus Clinical Research Centre

Reading, Berks, United Kingdom, RG2 7AG

Sponsors and Collaborators

Johnson & Johnson Consumer and Personal Products Worldwide

Investigators

• Study Director: Jerry Cottrell; J&J Consumer and Personal Products Worldwide

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
• ClinicalTrials.gov Identifier: NCT00819520
• Other Study ID Numbers: 075-00
• First Posted: January 9, 2009
• Last Update Posted: August 22, 2011
• Last Verified: August 2011

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:

pediculosis capitis; pediculus

Additional relevant MeSH terms:

Parasitic Diseases; Lice Infestations; Infections; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Ivermectin; Malathion; Antiparasitic Agents; Anti-Infective Agents; Cholinesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs