At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 38 enrolled
Drug / intervention
Ha44 Geldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically Under Maximal Use Conditions for the Treatment of Head Lice Infestation.
In Brief
A Phase 2 clinical trial evaluating Ha44 Gel for Head Lice Infestation. Completed, enrolled 38 participants.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead Lice Infestation
Countries--
CollaboratorsAccelovance, Target Health Inc.
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2013
Primary CompletionJul 2013
First PostedJul 2013
Study CompletionDec 2013
TodayJul 2026
First PostedJul 25, 2013
Enrollment StartMar 1, 2013
Primary CompletionJul 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.9 years ago
Interventions
Ha44 Geldrug
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.