Back to resultsA Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides.
Primary Purpose
Pediculosis
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
1) MOOV Head Lice Treatment (Ego Pharmaceutical).
Banlice Mousse Aerosol (Pfizer, Australia)
3) KP24 Medicated Foam (Nelson Laboratories)
Sponsored by
About this trial
This is an interventional treatment trial for Pediculosis focused on measuring Pediculus, capitis, lice
Eligibility Criteria
Inclusion Criteria:
- Male or female primary school children.
- Presence of live head lice (adults or nymphs) on the hair or scalp. The presence of live lice will be determined from a visual inspection of the hair and scalp and Dry-combing of the hair. Combing will stop immediately once live lice are observed. The presence of lice eggs alone is not a sufficient condition for inclusion in the trial.
- Be available for the duration of the trial.
- Parent / Guardian is willing not to use other head lice products or methods (e.g. combs) to treat their child's head lice for 21 days after the first treatment.
- Parent / Guardian has given written informed consent to their child's participation in the trial.
Exclusion Criteria:
- History of allergies or adverse reactions to head lice products or the components of the specific products being tested.
- Treatment with any head lice product in the month prior to Day 0.
- Presence of scalp disease(s).
- If a subject has a sibling in Grade 1-7 this sibling must also be enrolled in the study and treated on Day 0 otherwise the subject must be considered ineligible for enrolment.
- Subjects must have one fixed place of residence
Sites / Locations
- University of Queensland
Outcomes
Primary Outcome Measures
Absence of live head lice one week after the last treatment for each product (ie at Day 14 for KP24 and Banlice and at Day 21 for MOOV Head Lice Treatment)
Secondary Outcome Measures
Absence of live head lice one day after the first treatment of each product
Full Information
NCT ID
NCT00381082
First Posted
September 26, 2006
Last Updated
December 8, 2006
Sponsor
Uniquest Pty Ltd
Collaborators
Ego Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00381082
Brief Title
A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides.
Official Title
A Randomised, Controlled and Blinded Assessment Study of the Efficacy of MOOV Head Lice Treatment (Ego Pharmaceutical Pty. Ltd.) in the Treatment of Head Lice in Primary School Children.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Uniquest Pty Ltd
Collaborators
Ego Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
Objective
To compare the cure rates (defined as the complete absence of live lice, adults or nymphs, as diagnosed by wet-combing of three Australian approved head lice products for the treatment of primary school children with head lice infestation. The study design will be randomised and assessor-blind using three comparative parallel treatment groups.
The study population will consist of Queensland state primary school children (up to Year 7) with live head lice (adults or nymphs) on the hair or scalp who have not used any head lice product in the four weeks prior to the study.
Detailed Description
All products were used according to the manufacturer's instructions. KP24 and Banlice were applied twice separated by a one week interval. MOOV Head Lice Treatment was applied on Day 0, Day 7 and Day 14. The cure rate (absence of live lice) one day after the first administration for all products was a secondary outcome measure. The cure rate at 7 days after the final administration (Day 14 for Banlice or KP24 and at Day 21 for MOOV Head Lice Treatment) was the primary outcome measure. Siblings were treated if these were found to be infected as an enrolment criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediculosis
Keywords
Pediculus, capitis, lice
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
152 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
1) MOOV Head Lice Treatment (Ego Pharmaceutical).
Intervention Type
Drug
Intervention Name(s)
Banlice Mousse Aerosol (Pfizer, Australia)
Intervention Type
Drug
Intervention Name(s)
3) KP24 Medicated Foam (Nelson Laboratories)
Primary Outcome Measure Information:
Title
Absence of live head lice one week after the last treatment for each product (ie at Day 14 for KP24 and Banlice and at Day 21 for MOOV Head Lice Treatment)
Secondary Outcome Measure Information:
Title
Absence of live head lice one day after the first treatment of each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female primary school children.
Presence of live head lice (adults or nymphs) on the hair or scalp. The presence of live lice will be determined from a visual inspection of the hair and scalp and Dry-combing of the hair. Combing will stop immediately once live lice are observed. The presence of lice eggs alone is not a sufficient condition for inclusion in the trial.
Be available for the duration of the trial.
Parent / Guardian is willing not to use other head lice products or methods (e.g. combs) to treat their child's head lice for 21 days after the first treatment.
Parent / Guardian has given written informed consent to their child's participation in the trial.
Exclusion Criteria:
History of allergies or adverse reactions to head lice products or the components of the specific products being tested.
Treatment with any head lice product in the month prior to Day 0.
Presence of scalp disease(s).
If a subject has a sibling in Grade 1-7 this sibling must also be enrolled in the study and treated on Day 0 otherwise the subject must be considered ineligible for enrolment.
Subjects must have one fixed place of residence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Barker, PhD
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Queensland
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4072
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides.
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