DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Ivermectin in the Treatment of Head Lice

Information source: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lice Infestations

Intervention: ivermectin (Drug); malathion (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johnson & Johnson Consumer and Personal Products Worldwide

Official(s) and/or principal investigator(s):
Jerry Cottrell, Study Director, Affiliation: J&J Consumer and Personal Products Worldwide


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Absence or presence of live head lice

Secondary outcome:

Absence or presence of live head lice at alternative Study Days.

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.

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.


Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Chaim Sheba Medical Centre, Tel Hashomer 52621, Israel

Synexus Clinical Research Centre, Reading, Berks RG2 7AG, United Kingdom

Shandon Clinic, Cork, Co. Cork, Ireland

Hopital Avicenne, Bobigny, Paris 93009, France

Additional Information

Starting date: February 2004
Last updated: August 19, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017