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

Sponsor:	Uniquest Pty Ltd
Collaborator:	Ego Pharmaceuticals
Information provided by:	Uniquest Pty Ltd
ClinicalTrials.gov Identifier:	NCT00381082

Purpose

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.

Condition	Intervention	Phase
Pediculosis	Drug: 1) MOOV Head Lice Treatment (Ego Pharmaceutical). Drug: Banlice Mousse Aerosol (Pfizer, Australia) Drug: 3) KP24 Medicated Foam (Nelson Laboratories)	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Parasitic Diseases

U.S. FDA Resources

Further study details as provided by Uniquest Pty Ltd:

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

Estimated Enrollment:	152
Study Start Date:	September 2004
Estimated Study Completion Date:	November 2004

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.

Eligibility

Ages Eligible for Study:	5 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381082

Locations

Australia, Queensland
University of Queensland
Brisbane, Queensland, Australia, 4072

Sponsors and Collaborators

Uniquest Pty Ltd

Ego Pharmaceuticals

Investigators

Principal Investigator:

Stephen Barker, PhD

The University of Queensland

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00381082 History of Changes
Other Study ID Numbers:	MOOV-1 Version 1 22 Sep 2004
Study First Received:	September 26, 2006
Last Updated:	December 8, 2006
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Uniquest Pty Ltd:

Pediculus
capitis
lice

Additional relevant MeSH terms:

Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic

Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012