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A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00381082
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : December 12, 2006
Sponsor:
Collaborator:
Ego Pharmaceuticals
Information provided by:
Uniquest Pty Ltd

Tracking Information
First Submitted Date  ICMJE September 26, 2006
First Posted Date  ICMJE September 27, 2006
Last Update Posted Date December 12, 2006
Study Start Date  ICMJE September 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2006)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00381082 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2006)
Absence of live head lice one day after the first treatment of each product
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides.
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Pediculosis
Intervention  ICMJE
  • Drug: 1) MOOV Head Lice Treatment (Ego Pharmaceutical).
  • Drug: Banlice Mousse Aerosol (Pfizer, Australia)
  • Drug: 3) KP24 Medicated Foam (Nelson Laboratories)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 26, 2006)
152
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00381082
Other Study ID Numbers  ICMJE MOOV-1 Version 1 22 Sep 2004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Uniquest Pty Ltd
Collaborators  ICMJE Ego Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Stephen Barker, PhD The University of Queensland
PRS Account Uniquest Pty Ltd
Verification Date December 2006

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