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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

January 8, 2009
August 19, 2011
February 2004
September 2004   (final data collection date for primary outcome measure)
Absence or presence of live head lice [ Time Frame: Study Day 15 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00819520 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lice Infestations
  • 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®
  • Drug: malathion
    Two single applications of malathion 0.5% lotion (Days 1 and 8) plus 2 single doses of placebo tablets
    Other Name: Prioderm®
  • Experimental: Ivermectin
    ivermectin Stromectol®)
    Intervention: Drug: ivermectin
  • Active Comparator: Malathion
    malathion(Prioderm®)
    Intervention: Drug: malathion
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
812
October 2004
September 2004   (final data collection date for primary outcome measure)

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
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Ireland,   Israel,   United Kingdom
 
NCT00819520
075-00
No
Johnson & Johnson Consumer and Personal Products Worldwide
Johnson & Johnson Consumer and Personal Products Worldwide
Not Provided
Study Director: Jerry Cottrell J&J Consumer and Personal Products Worldwide
Johnson & Johnson Consumer and Personal Products Worldwide
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP