A randomised, assessor blind, comparative trial of MOOV (reg. trade mark) Lotion, MOOV (reg. trade mark) Shampoo and KP24 Medicated Foam in the treatment of head lice in childre

Phase 4

Completed

• Conditions: head lice; Skin - Dermatological conditions

• Registration Number: ACTRN12607000564459
• Lead Sponsor: Ego Pharmaceuticals Pty. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

•Male or female primary school-aged 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 detected. The presence of lice eggs alone is not a sufficient condition for inclusion in the trial.
•Available for the duration of the trial.
•Parent / Guardian have 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 4 weeks prior to participation in this trial.
•Treatment with any head lice product during the trial.
•Treatment with a head lice comb during the trial if the subject is found to be louse free at Day 21 for any of the three treatment arms.
•Presence of scalp disease(s).
•If the subject has a sibling in Grade 1-7, who lived at the same residence during the treatment period the sibling must be examined for lice and if infested, enrolled in this study or wet combed out on days 0, 7 and 14, relative to the subject.
•Subjects must have one fixed place of residence during the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint will be the louse free rate at Day 21 for KP24 Medicated Foam, MOOV Shampoo and MOOV Lotion, as diagnosed by wet-combing of the hair and scalp in the intention-to-treat population.[presence of head lice at Day 21]

Secondary Outcome Measures

Name	Time	Method
a)the louse free rate at Day 21 for PP subjects treated with KP24 Medicated Foam verses MOOV Shampoo or MOOV Lotion. <br>b)the presence of head lice at Day 1, as diagnosed by dry-combing of the hair and scalp, for intention-to-treat and per-protocol subjects treated with KP24 Medicated Foam verses MOOV Shampoo or MOOV Lotion.[presence of head lice at Day 1 and Day 21]