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

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ClinicalTrials.gov Identifier: NCT03257943
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

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

Condition or disease Intervention/treatment Phase
Lice; Head Lice Drug: Ivermectin Lotion, 0.5% Drug: SKLICE (ivermectin) Lotion, 0.5% Drug: Vehicle of the Test product Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 20, 2017
Actual Primary Completion Date : June 27, 2017
Actual Study Completion Date : August 18, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

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 Name: 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 Name: 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 Name: placebo




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257943


Locations
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United States, New York
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, United States, 10532
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Catawba Research http://catawbaresearch.com/contact/

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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT03257943     History of Changes
Other Study ID Numbers: IVRL 1604
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Ivermectin
Antiparasitic Agents
Anti-Infective Agents