CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 239 enrolled
Drug / intervention
Benzyl Alcohol Lotion 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/NCT02624843
NCT02624843Phase 3Completed
CompareCT.gov

Bioequivalence Study for Benzyl Alcohol Lotion 5% (Hi-Tech Pharmacal Co. LTD) and Ulesfia (Benzyl Alcohol Lotion 5%) (Shionogi Inc.) in the Treatment of Head Lice and Their Ova.

Akorn, Inc.·interventional·Posted Dec 9, 2015·Updated Jan 27, 2021

In Brief

A Phase 3 clinical trial evaluating Benzyl Alcohol Lotion 5%, Ulesfia (benzyl alcohol lotion) 5%, and 1 other intervention for Head Lice. Completed, enrolled 239 participants across 4 sites.

Detailed Summary

To establish the therapeutic equivalence and safety of a generic Benzyl Alcohol Lotion 5% with Ulesfia Lotion 5% in eradication of head lice in the study subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead Lice
CountriesUnited States
CollaboratorsSouth Florida Family Health and Research Centers, Axis Clinical Trials

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 9, 2015
Enrollment StartAug 1, 2015
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.6 years ago

Interventions

Benzyl Alcohol Lotion 5%drug

White topical lotion

Ulesfia (benzyl alcohol lotion) 5%drug

White topical lotion

Placebodrug

White topical lotion