NCT02022215

Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Dose-Ranging Study to Investigate the Efficacy and Safety of ME1111 in Patients With Mild to Moderate Onychomycosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Meiji Seika Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the safety and efficacy of high and low strength of ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	ME1111 Solution, Low strength	ME1111 Solution, Low strength, applied once daily for 48 weeks
DRUG	ME1111 Solution, High strength	ME1111 Solution, High strength, applied once daily for 48 weeks
DRUG	Matching Vehicle Solution	Matching Vehicle Solution, applied once daily for 48 weeks

Timeline

• Start date: 2013-12-19
• Primary completion: 2015-10-28
• Completion: 2016-03-01
• First posted: 2013-12-27
• Last updated: 2024-03-18

Locations

31 sites across 1 country: United States