MedTrace Logo

Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

NCT02022215 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2024-03-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Meiji Seika Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Meiji Study Director · Meiji Seika Pharma Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-19
Primary Completion
2015-10-28
Completion
2016-03-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02022215 on ClinicalTrials.gov