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

NCT03257943 | Completed Phase 1 FDA Drug

• 1 other identifier: IVRL 1604
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lice; Head Lice

Outcome Measures

Primary Outcomes (1)

• Demonstration of Bioequivalence in proportion of index subjects who are lice free

  Demonstration of Bioequivalence in proportion of index subjects who are lice free

  Day 15 (14 days after application of study treatment)

Study Arms (3)

Ivermectin Lotion, 0.5%

EXPERIMENTAL

One 10 minute application, under at-home use conditions

Drug: Ivermectin Lotion, 0.5%

SKLICE (ivermectin) Lotion, 0.5%

ACTIVE COMPARATOR

One 10 minute application, under at-home use conditions

Drug: SKLICE (ivermectin) Lotion, 0.5%

Vehicle of the Test product

PLACEBO COMPARATOR

One 10 minute application, under at-home use conditions

Drug: Vehicle of the Test product

Interventions

Ivermectin Lotion, 0.5% DRUG

Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)

Also known as: ivermectin

Ivermectin Lotion, 0.5%

SKLICE (ivermectin) Lotion, 0.5% DRUG

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

Also known as: ivermectin

SKLICE (ivermectin) Lotion, 0.5%

Vehicle of the Test product DRUG

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

Also known as: placebo

Vehicle of the Test product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, 10532, United States

Location

MeSH Terms

Conditions

Lice Infestations

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Catawba Research

  http://catawbaresearch.com/contact/

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: August 22, 2017
• Study Start: March 20, 2017
• Primary Completion: June 27, 2017
• Study Completion: August 18, 2017
• Last Updated: May 18, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)