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Clinical Endpoint Study of Ivermectin 0.5% Lotion

NCT03301649 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 905

Last updated 2019-12-20

Study results available
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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.

Conditions

  • Head Lice

Interventions

DRUG

Generic Ivermectin Lotion 0.5%

Topical lotion, generic formulation of the brand product.

DRUG

Sklice® (Ivermectin) Lotion 0.5%

Topical lotion, brand product.

DRUG

Vehicle Lotion

Topical lotion, placebo. Has no active ingredient.

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Actavis Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-07
Primary Completion
2018-03-12
Completion
2018-03-12
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 NCT03301649 on ClinicalTrials.gov