At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 371 enrolled
Drug / intervention
0.5% Ivermectin Cream +1 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.
A Double-Blind Randomized Study to Compare the Efficacy, Safety, and Local Tolerability of a 0.5% Ivermectin Cream Compared to a Topical Vehicle Control in Subjects With Pediculus Humanus Capitis Infestation
In Brief
A Phase 3 clinical trial evaluating 0.5% Ivermectin Cream and Placebo control for Head Lice. Completed, enrolled 371 participants across 7 sites.
Detailed Summary
The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead Lice
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2010
Enrollment StartMar 2010
Primary CompletionJun 2010
Study CompletionJul 2010
TodayJul 2026
First PostedFeb 12, 2010
Enrollment StartMar 1, 2010
Primary CompletionJun 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.4 years ago
Interventions
0.5% Ivermectin Creamdrug
Up to 4 ounces of 0.5% Ivermectin Cream applied to hair and scalp on day 1.
Placebo controldrug
up to 4 ounces of topical vehicle control to head and scalp on day 1.