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A Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5%

NCT03257943 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2018-05-18

No results posted yet for this study

Summary

A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5%

Conditions

  • Lice; Head Lice

Interventions

DRUG

Ivermectin Lotion, 0.5%

Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)

DRUG

SKLICE (ivermectin) Lotion, 0.5%

SKLICE (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC)

DRUG

Vehicle of the Test product

Vehicle for Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Catawba Research · http://catawbaresearch.com/contact/

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2017-06-27
Completion
2017-08-18
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 NCT03257943 on ClinicalTrials.gov