Clinical Trial: Phase 3 Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Multicenter, Vehicle-Controlled Study of the Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation

Brief Summary: The purpose of the study is to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at home.

Detailed Summary:
Sponsor: Hatchtech Pty Ltd

Current Primary Outcome: Proportion of index subjects who are lice-free at all follow-up visits through to the Day 14 visit. [ Time Frame: 14 days ]

The outcome is measured by lice evaluations from baseline through follow up visits.


Original Primary Outcome: Proportion of index subjects who are lice-free at all follow-up visits through to the Day 14 visit. [ Time Frame: 14 (+2) days ]

The outcome is measured by lice evaluations on baseline, day 1, day 7 and day 14 visits.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hatchtech Pty Ltd

Dates:
Date Received: February 11, 2014
Date Started: February 2014
Date Completion:
Last Updated: September 9, 2015
Last Verified: August 2015