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A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice

NCT03337490 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2020-09-17

Study results available
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Summary

This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study.

Conditions

  • Head Lice

Interventions

DRUG

Ivermectin 0.5% Topical Application Lotion

Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.

DRUG

Ivermectin 0.5% Topical Application Lotion [SKLICE]

Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.

DRUG

Placebo 0% Lotion

Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.

Sponsors & Collaborators

  • bioRASI, LLC

    collaborator INDUSTRY

  • Mayne Pharma International Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-02
Primary Completion
2017-12-04
Completion
2017-12-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03337490 on ClinicalTrials.gov