CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 905 enrolled
Drug / intervention
Generic Ivermectin Lotion 0.5% +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.

Search/NCT03301649
NCT03301649Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Ivermectin Lotion 0.5% (Actavis Laboratories UT, Inc.) to SKLICE® (Ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC) in the Treatment of Human Head Lice Infestation

Actavis Inc.·interventional·Posted Oct 4, 2017·Updated Dec 20, 2019

In Brief

A Phase 3 clinical trial evaluating Generic Ivermectin Lotion 0.5%, Sklice® (Ivermectin) Lotion 0.5%, and 1 other intervention for Head Lice. Completed, enrolled 905 participants across 1 site.

Detailed Summary

This clinical study is designed to evaluate the clinical (therapeutic) effect of a generic ivermectin lotion 0.5% (Actavis Laboratories UT, Inc.) relative to that of the Food and Drug Administration (FDA) Reference Listed Drug (RLD) SKLICE® (ivermectin) lotion, 0.5% (Arbor Pharmaceuticals, LLC) in participants with active head lice infestation. Additionally, both the test and reference (that is; the RLD) treatments were tested for superiority to a placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead Lice
CountriesUnited States
CollaboratorsTeva Pharmaceuticals USA

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 4, 2017
Enrollment StartOct 7, 2017
Primary CompletionMar 12, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.7 years ago

Interventions

Generic Ivermectin Lotion 0.5%drug

Topical lotion, generic formulation of the brand product.

Sklice® (Ivermectin) Lotion 0.5%drug

Topical lotion, brand product.

Vehicle Lotiondrug

Topical lotion, placebo. Has no active ingredient.