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

Pediculosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381082
• Other study ID #: MOOV-1 Version 1 22 Sep 2004
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 26, 2006
• Last updated: December 8, 2006
• Start date: September 2004
• Est. completion date: November 2004

Study information

• Verified date: December 2006
• Source: Uniquest Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: November 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pediculosis

Intervention

Drug:
• 1) MOOV Head Lice Treatment (Ego Pharmaceutical).

• Banlice Mousse Aerosol (Pfizer, Australia)

• 3) KP24 Medicated Foam (Nelson Laboratories)

Locations

Country	Name	City	State
Australia	University of Queensland	Brisbane	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Uniquest Pty Ltd	Ego Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Absence of live head lice one day after the first treatment of each product