At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 142 enrolled
Drug / intervention
Group A - Low-Dose Ha44 0.37% w/w +2 moredrug
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.
An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
In Brief
A Phase 2 clinical trial evaluating Group A - Low-Dose Ha44 0.37% w/w, Group B - High Dose Ha44 Gel 0.74% w/w, and 1 other intervention for Pediculosis. Completed, enrolled 142 participants across 2 sites.
Detailed Summary
Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediculosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedApr 2011
Primary CompletionAug 2011
Study CompletionMar 2012
TodayJul 2026
First PostedApr 18, 2011
Enrollment StartApr 1, 2011
Primary CompletionAug 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.2 years ago
Interventions
Group A - Low-Dose Ha44 0.37% w/wdrug
Low Dose Ha44 Gel applied to scalp and hair for 10 minutes
Group B - High Dose Ha44 Gel 0.74% w/wdrug
High Dose Ha44 Gel applied to scalp and hair for 10 minutes
Group C - Placebodrug
Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes