|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00819520 |
|
Date of registration:
|
08/01/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Ivermectin in the Treatment of Head Lice
|
|
Scientific 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 |
|
Date of first enrolment:
|
February 2004 |
|
Target sample size:
|
812 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00819520 |
|
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
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
France
|
Ireland
|
Israel
|
United Kingdom
| | | | |
|
Contacts
|
|
Name:
|
Jerry Cottrell |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
J&J Consumer and Personal Products Worldwide |
| | |
|
Key inclusion & exclusion 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
Age minimum:
2 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Lice Infestations
|
|
Intervention(s)
|
|
Drug: ivermectin
|
|
Drug: malathion
|
|
Primary Outcome(s)
|
|
Absence or presence of live head lice
[Time Frame: Study Day 15]
|
|
Secondary Outcome(s)
|
|
Absence or presence of live head lice at alternative Study Days.
[Time Frame: 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.
[Time Frame: throughout duration of the study (+ 30 days for spontaneously reported SAEs)]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|