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Ivermectin in the Treatment of Head Lice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00819520
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : August 22, 2011
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

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.

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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

Resource links provided by the National Library of Medicine

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
Drug: malathion
Two single applications of malathion 0.5% lotion (Days 1 and 8) plus 2 single doses of placebo tablets
Other Name: Prioderm®

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) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00819520

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Hopital Avicenne
Bobigny, Paris, France, 93009
Shandon Clinic
Cork, Co. Cork, Ireland
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
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Study Director: Jerry Cottrell J&J Consumer and Personal Products Worldwide
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide Identifier: NCT00819520    
Other Study ID Numbers: 075-00
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: August 22, 2011
Last Verified: August 2011
Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
pediculosis capitis
Additional relevant MeSH terms:
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Parasitic Diseases
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antiparasitic Agents
Anti-Infective Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs