Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation
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|ClinicalTrials.gov Identifier: NCT01907490|
Recruitment Status : Completed
First Posted : July 25, 2013
Results First Posted : February 9, 2015
Last Update Posted : April 26, 2017
The purpose of the study is to evaluate the safety and tolerability of a single application of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions.
Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in Ha44 vehicle) under maximal use conditions.
|Condition or disease||Intervention/treatment||Phase|
|Head Lice Infestation||Drug: Ha44 Gel||Phase 2|
This is an open-label safety and pharmacokinetic (PK) study involving a single application of Ha44 Gel 0.74% administered under maximal use conditions.
All participants must have an active head lice infestation (at least 3 live lice) and be 6 months to 17 years of age. The study will enroll approximately 36 pediatric subjects between the ages of 6 months and 17 years.
Pediatric PK samples will be collected at 0 (predose), 30 and 60 mins and 2 and 8 hrs time points.
More than one household member with an active lice infestation may participate in the study. Eligible subjects will be consented and screened for study eligibility on Day 0 (Visit 1). All subjects will return to the study site for three follow-up clinic visits at Days 1, 7 and 14. The maximum study duration for a subject is 16 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically Under Maximal Use Conditions for the Treatment of Head Lice Infestation.|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||December 2013|
Ha44 Gel 0.74%, topical solution, maximum feasible amount applied for 10 minutes
Drug: Ha44 Gel
Eligible subjects will be treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair.
Other Name: Benzyl Alcohol
- Number of the Subjects With AEs. [ Time Frame: 3 months ]Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.
- Pk Parameters: Cmax [ Time Frame: 3 months ]Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation
- PK Parameters: Tmax [ Time Frame: 3 months ]Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation
- PK Parameters: AUC [ Time Frame: 3 months ]Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation