Ivermectin in the Treatment of Head Lice

NCT00819520 | Completed Phase 3

• 1 other identifier: 075-00
• Study Type: interventional
• Target: 812
• Locations: 4 countries
• Sites: 4

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.

Conditions

Lice Infestations

Keywords

pediculosis capitis; pediculus

Outcome Measures

Primary Outcomes (1)

• Absence or presence of live head lice

  Study Day 15

Secondary Outcomes (2)

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

  Study Days 2, 8, 22, 29

• 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.

  throughout duration of the study (+ 30 days for spontaneously reported SAEs)

Study Arms (2)

Ivermectin

EXPERIMENTAL

ivermectin Stromectol®)

Drug: ivermectin

Malathion

ACTIVE COMPARATOR

malathion(Prioderm®)

Drug: malathion

Interventions

ivermectin DRUG

Two single doses of oral ivermectin 400 mcg/kg (Days 1 and 8) plus 2 single applications of placebo lotion

Also known as: Stromectol®

Ivermectin

malathion DRUG

Two single applications of malathion 0.5% lotion (Days 1 and 8) plus 2 single doses of placebo tablets

Also known as: Prioderm®

Malathion

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (4)

Hopital Avicenne

Bobigny, Paris, 93009, France

Location

Shandon Clinic

Cork, Co. Cork, Ireland

Location

Chaim Sheba Medical Centre

Tel Litwinsky, Tel Hashomer, 52621, Israel

Location

Synexus Clinical Research Centre

Reading, Berks, RG2 7AG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 20220184 DERIVED

MeSH Terms

Conditions

Lice Infestations

Interventions

Ivermectin; Malathion

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organothiophosphorus Compounds; Sulfur Compounds

Study Officials

• Jerry Cottrell

  J&J Consumer and Personal Products Worldwide

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 9, 2009
• Study Start: February 1, 2004
• Primary Completion: September 1, 2004
• Study Completion: October 1, 2004
• Last Updated: August 22, 2011

Record last verified: 2011-08

Locations

FR (1); IL (1); IE (1); GB (1)