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

May 16, 2018 updated by: Taro Pharmaceuticals USA

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Ivermectin Lotion, 0.5% in the Treatment of Subjects With Active Infestation With Head Lice and Their Ova

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5% to Sklice (Ivermectin) Lotion, 0.5% and both active treatment to a placebo control in the treatment of subjects with active infestation with head lice and their Ova

Study Type

Interventional

Enrollment (Actual)

413

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Hawthorne, New York, United States, 10532
        • Taro Pharmaceuticals USA Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects 18 years of age or older must have provided IRB-approved written informed consent and sign a HIPAA authorization.
  • Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.

Exclusion Criteria:

  • Subjects with a history of hypersensitivity or allergy to or any component of the study product.
  • Subject with history of irritation or sensitivity to pediculicides or hair care products.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ivermectin Lotion, 0.5%
One 10 minute application, under at-home use conditions
Drug: Ivermectin Lotion, 0.5%
Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
Other Names:
  • ivermectin
Active Comparator: SKLICE (ivermectin) Lotion, 0.5%
One 10 minute application, under at-home use conditions
Drug: SKLICE (ivermectin) Lotion, 0.5%
SKLICE (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC)
Other Names:
  • ivermectin
Placebo Comparator: Vehicle of the Test product
One 10 minute application, under at-home use conditions
Drug: Vehicle of the Test product
Vehicle for Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstration of Bioequivalence in proportion of index subjects who are lice free
Time Frame: Day 15 (14 days after application of study treatment)
Demonstration of Bioequivalence in proportion of index subjects who are lice free
Day 15 (14 days after application of study treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taro Pharmaceuticals USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2017

Primary Completion (Actual)

June 27, 2017

Study Completion (Actual)

August 18, 2017

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

August 18, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

May 18, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVRL 1604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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