NCT03337490

A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice

A Randomized, Multi-Center, Double-blind, Placebo Controlled, Parallel Group Trial to Evaluate Efficacy and Safety of Mayne Pharma's Ivermectin 0.5% Lotion Compared to Sklice® Ivermectin 0.5% Lotion in the Treatment of Head Lice

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: Mayne Pharma International Pty Ltd · Industry
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study.

Detailed description

This study is comprised of two phases: screening and treatment. The screening period is 24 hours, followed by the treatment phase of 15 ± 3 days. During the treatment phase, subjects will be randomized to either test, reference of placebo treatments (3:3:1) in a double-blind manner in an outpatient setting. Once eligibility is confirmed, randomization will occur at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 15 ± 3 days in duration wherein subject will receive treatment with investigational product (either test, reference or placebo) on Day 1 or baseline (visit 2). Efficacy will be evaluated at Day 15. Safety and tolerability will be evaluated based upon AEs and patient self-assessments and self-assessments collected during follow-up visits.

Conditions

• Head Lice

Interventions

Type	Name	Description
DRUG	Ivermectin 0.5% Topical Application Lotion	Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.
DRUG	Ivermectin 0.5% Topical Application Lotion [SKLICE]	Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.
DRUG	Placebo 0% Lotion	Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.

Timeline

• Start date: 2017-10-02
• Primary completion: 2017-12-04
• Completion: 2017-12-18
• First posted: 2017-11-09
• Last updated: 2020-09-17
• Results posted: 2020-09-17

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study