Ivermectin in the Treatment of Head Lice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00819520
First received: January 8, 2009
Last updated: August 19, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Lice Infestations
Drug: ivermectin
Drug: malathion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Absence or presence of live head lice [ Time Frame: Study Day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absence or presence of live head lice at alternative Study Days. [ Time Frame: Study Days 2, 8, 22, 29 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 812
Study Start Date: February 2004
Study Completion Date: October 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819520

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

No publications provided by Johnson & Johnson Consumer and Personal Products Worldwide

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00819520     History of Changes
Other Study ID Numbers: 075-00
Study First Received: January 8, 2009
Last Updated: August 19, 2011
Health Authority: France: Direction Générale de la Santé
Ireland: Irish Medicines Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ministry of Health

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
pediculosis capitis
pediculus

Additional relevant MeSH terms:
Parasitic Diseases
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Ivermectin
Malathion
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014