Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
|ClinicalTrials.gov Identifier: NCT02097485|
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : April 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Head Lice Infestation||Drug: Abametapir Lotion 0.74% w/w Drug: Vehicle Lotion||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomised, Double-Blind, Vehicle-Controlled Study of Ovicidal Efficacy and Safety of Abametapir 0.74% Administered for the Treatment of Head Lice Infestation|
|Study Start Date :||May 2014|
|Primary Completion Date :||September 2014|
|Study Completion Date :||October 2014|
Active Comparator: Abametapir Lotion 0.74% w/w
Topically administered to hair and scalp for 10 minutes application.
Drug: Abametapir Lotion 0.74% w/w
200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.
Placebo Comparator: Vehicle Lotion
Administered to scalp and hair for 10 minutes application.
Drug: Vehicle Lotion
control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.
- Proportion of hatched eggs pre treatment relative to proportion of hatched eggs post treatment for the abametapir and vehicle treated eggs following 14 day incubation. [ Time Frame: 14 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097485
|National Head Lice Treatment Centre|
|Ringwood East, Victoria, Australia, 3135|