Back to resultsA Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5%
Primary Purpose
Lice; Head Lice
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ivermectin Lotion, 0.5%
SKLICE (ivermectin) Lotion, 0.5%
Vehicle of the Test product
Sponsored by
About this trial
This is an interventional treatment trial for Lice; Head Lice
Eligibility 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.
Sites / Locations
- Taro Pharmaceuticals USA Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Ivermectin Lotion, 0.5%
SKLICE (ivermectin) Lotion, 0.5%
Vehicle of the Test product
Arm Description
One 10 minute application, under at-home use conditions
One 10 minute application, under at-home use conditions
One 10 minute application, under at-home use conditions
Outcomes
Primary Outcome Measures
Demonstration of Bioequivalence in proportion of index subjects who are lice free
Demonstration of Bioequivalence in proportion of index subjects who are lice free
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03257943
Brief Title
A Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5%
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
June 27, 2017 (Actual)
Study Completion Date
August 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5%
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lice; Head Lice
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
413 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ivermectin Lotion, 0.5%
Arm Type
Experimental
Arm Description
One 10 minute application, under at-home use conditions
Arm Title
SKLICE (ivermectin) Lotion, 0.5%
Arm Type
Active Comparator
Arm Description
One 10 minute application, under at-home use conditions
Arm Title
Vehicle of the Test product
Arm Type
Placebo Comparator
Arm Description
One 10 minute application, under at-home use conditions
Intervention Type
Drug
Intervention Name(s)
Ivermectin Lotion, 0.5%
Other Intervention Name(s)
ivermectin
Intervention Description
Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
Intervention Type
Drug
Intervention Name(s)
SKLICE (ivermectin) Lotion, 0.5%
Other Intervention Name(s)
ivermectin
Intervention Description
SKLICE (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC)
Intervention Type
Drug
Intervention Name(s)
Vehicle of the Test product
Other Intervention Name(s)
placebo
Intervention Description
Vehicle for Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
Primary Outcome Measure Information:
Title
Demonstration of Bioequivalence in proportion of index subjects who are lice free
Description
Demonstration of Bioequivalence in proportion of index subjects who are lice free
Time Frame
Day 15 (14 days after application of study treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catawba Research
Organizational Affiliation
http://catawbaresearch.com/contact/
Official's Role
Study Chair
Facility Information:
Facility Name
Taro Pharmaceuticals USA Inc.
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5%
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