Status:

COMPLETED

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

Lead Sponsor:

Uniquest Pty Ltd

Collaborating Sponsors:

Ego Pharmaceuticals

Conditions:

Pediculosis

Eligibility:

All Genders

5-12 years

Phase:

PHASE2

PHASE3

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 p...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2004

Trial Type :

INTERVENTIONAL

End Date :

November 1 2004

Estimated Enrollment :

152 Patients enrolled

Trial Details

Trial ID

NCT00381082

Start Date

September 1 2004

End Date

November 1 2004

Last Update

December 12 2006

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Queensland

Brisbane, Queensland, Australia, 4072