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Bioequivalence Study for Benzyl Alcohol Lotion 5%.

NCT02624843 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2021-01-27

Study results available
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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.

Conditions

  • Head Lice

Interventions

DRUG

Benzyl Alcohol Lotion 5%

White topical lotion

DRUG

Ulesfia (benzyl alcohol lotion) 5%

White topical lotion

DRUG

Placebo

White topical lotion

Sponsors & Collaborators

  • South Florida Family Health and Research Centers

    collaborator NETWORK

  • Axis Clinical Trials

    collaborator OTHER

  • Akorn, Inc.

    lead INDUSTRY

Principal Investigators

  • Elisabeth Rivera · South Florida Family Health and Research Centers

  • Lydie Hazan, MD · Axis Clinical Trials

  • Patrick Clarke, MD · Axis Clinical Trials

  • Lidia E Serrano · South Florida Family Health and Research Centers

  • Nancy Pyram-Bernard, D.O. · South Florida Family Health and Research Centers

  • Ian F Burgess, M.Phil. · Insect Research and Development LTD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02624843 on ClinicalTrials.gov